
Tips & FAQs
You have questions. We have answers.
HCP Program Questions
Does your program include support?
Yes—clients get a dedicated specialist available year-round via phone and email to support both technical and compliance needs.
Is your system complicated and difficult?
Not at all. The software is easy to use, and each client is guided by a specialist from day one.
Do you offer a preview of your services?
Yes—a free consultation and review of your current compliance circumstances is available to show how the program can fill gaps or create a complete solution.
We are a small group; can we afford a custom compliance program?
Absolutely. Pricing is scaled based on the number of users, so small groups can access the same level of support as larger organizations.
How do you sign up for your services?
You're assigned an account manager who handles billing and activates your account following your payment information.
Do you require long‑term contracts?
Most of our services are a 12-month agreement; longer-term commitments come with a price lock guarantee.
How long does your program take to set up?
Depending on your practice size, the program and training reminders can go live in a couple of weeks. Your specialist works with your schedule to ensure a smooth launch.
What if I get audited?
Audits can happen at any time, whether from OCR (HIPAA), OSHA, CMS, or state agencies. If you don't have proper documentation in place, audits can lead to significant fines, corrective action plans, or even loss of contracts.
The good news: if you've built a compliance program and kept records up to date, an audit becomes much less stressful. Regulators want to see that your organization has policies, training, risk assessments, and corrective actions documented and actively maintained.
With HCP, you'll have all of this organized in one place. We provide policies, training records, risk analysis reports, breach logs, and more. Backed by expert support, so you can respond quickly and confidently if an audit occurs.
Is the hotline only for FW&A or can clients use it as they choose?
It is not used exclusively for FW&A reports. It can be used to report harassment, discrimination, HIPAA violations, etc. Clients can utilize the hotline however they choose.
General Compliance Questions
How often do compliance regulations change?
Compliance regulations don't follow a set schedule; they can change at any time. Agencies like HHS (HIPAA), OSHA, CMS, and state regulators regularly update requirements in response to new laws, technology, enforcement priorities, and industry risks. Some years bring only small clarifications, while others introduce sweeping changes that affect every healthcare organization.
That's why it's critical to have a program that not only meets today's standards but also keeps up with tomorrow's updates. Ongoing monitoring, policy updates, and staff training ensure your organization stays protected and audit-ready.
Why do I need a compliance program?
A compliance program isn't just a box to check; it's your organization's safety net. Healthcare is one of the most heavily regulated industries, and government agencies expect providers and business associates to proactively prevent violations. Without a formal program, your practice is at higher risk for:
-
Costly fines and penalties from HIPAA, OSHA, or CMS violations
-
Audits and investigations that disrupt operations and drain resources
-
Patient safety issues from overlooked workplace or privacy requirements
-
Reputational damage that erodes trust with patients, payers, and partners
A well-structured compliance program helps you stay ahead of changing regulations, train your staff effectively, and document your efforts. This not only reduces risk but also shows regulators you're committed to protecting patients, employees, and your organization.
Do my employees have to be trained each year?
Yes. Annual training is required for most healthcare compliance areas, including HIPAA, OSHA, and Corporate Compliance. Regulations expect organizations to provide regular, up-to-date education so employees understand their responsibilities and can respond appropriately to risks.
In addition to yearly training, employees must also receive training when new policies or procedures are introduced, when regulations change, or when their job duties expose them to new risks (for example, a new chemical hazard in the workplace or access to patient health information).
Annual training not only meets regulatory requirements, it also helps reinforce a culture of compliance, reduces the risk of violations, and protects both your patients and your staff.
What are the essential elements of a robust corporate compliance program?
An effective compliance program should include the following essential elements:
- Written Policies and Procedures: Clearly define the organization's commitment to compliance with federal and state regulations.
- Designated Compliance Officer and Committee: Appoint a Chief Compliance Officer (CCO) independent from business operations and establish a Corporate Compliance Committee with senior management and departmental representatives.
- Effective Training and Education: Develop and implement regular training programs for all employees and related entities, covering topics such as compliance, HIPAA, fraud, waste, and abuse prevention.
- Strong Lines of Communication: Foster an open and transparent communication environment, encouraging employees to report suspected compliance violations without fear of retaliation.
- Enforcement and Discipline: Clearly define disciplinary actions for non-compliance and apply them consistently and fairly.
- Internal Monitoring and Auditing: Regularly monitor and audit operational activities to identify potential compliance risks.
- Prompt Response to Compliance Issues: Establish a process for investigating reported compliance violations, taking appropriate disciplinary action, and implementing corrective action plans to prevent future violations.
Does a compliance committee meeting need to include a certain number of people and do they need to be the same assigned people each time?
We recommend that the members of the compliance committee include anyone who has oversight over compliance issues; HIPAA, OSHA, contracting, billing/coding, etc. This will include compliance officers and can include other managers/administrators. If not met already through the inclusion of managers, it should also have representatives from the various departments of the organization to make sure that the various needs and perspectives of those departments are being represented. Additional members can be added temporarily as the focus of the compliance activities change; i.e. an audit or other special project, but the core members will always be the same.
Regulatory Updates
How often do compliance regulations change?
Assessments need to be conducted annually as healthcare compliance regulations are frequently changing.
How is Open AI impacting compliance?
Proper
implementation of AI in healthcare must be used to protect medical practice,
the employees, and the patients. Here are some concerns relating to Open AI in healthcare:
Data Breaches: HIPAA's primary concern regarding AI is the storage and processing of patient data. If these systems are not adequately protected, they can become targets for cyber-attacks. Medical practices account for about a quarter of all online cyber-attacks, exposing private patient data and resulting in significant fines.
Inadequate Data Anonymization: AI models rely on substantial datasets to produce results. If patient data is not correctly anonymized, sensitive information might be exposed.
Misuse of Data: A significant concern with AI models is the potential misuse of data. AI algorithms can inadvertently use patient data for purposes beyond the intended scope. For instance, research applications of AI may proceed without proper patient consent, leading to compliance violations.
Insufficient Audit Trails: Proper documentation is critical in healthcare, and audit trails are essential for maintaining HIPAA compliance. Tracking data processed by AI is complex, increasing the risk of violations if proper measures are not in place.
What are the recent regulatory updates announced by HHS and the FTC regarding healthcare privacy and breach notifications?
On February 8, 2024, the Department of Health and Human Services (HHS) issued a final rule modifying the Confidentiality of Substance Use Disorder Patient Records regulation (SUD) at 42 CFR part 2 (Part 2). This modification aligns SUD more closely with HIPAA, allowing healthcare providers to use a single consent form and implementing breach notification requirements similar to HIPAA. Additionally, the final rule replaces the criminal penalties in SUD with both civil and criminal enforcement authorities, mirroring HIPAA's enforcement mechanisms.
On April 22, 2024, the HHS Office for Civil Rights issued the final HIPAA Privacy Rule to support reproductive health care privacy, enhancing patient-provider confidentiality for those seeking lawful reproductive health care (RHC). Key updates include prohibiting covered entities from using and disclosing PHI for purposes related to RHC under certain conditions, requiring a signed attestation for requests for PHI potentially related to RHC, and necessitating updates to the Notice of Privacy Practices.
Finally, on April 26, 2024, the Federal Trade Commission (FTC) finalized changes to its Health Breach Notification Rule (HBNR) under a split party-line vote. These changes clarify the applicability of the HBNR to health apps and similar technologies. The rule now mandates that vendors of health records, including health apps—generally not covered by HIPAA—must notify individuals, the FTC, and, in some cases, the media, in the event of a breach or impermissible disclosure of unsecured personally identifiable health data. For further details, refer to the previous alert on the HBNR updates.
HIPAA Compliance
Do you include a security risk analysis (SRA)?
Yes. A Security Risk Analysis (SRA) is a core requirement under the HIPAA Security Rule, and it's also tied to CMS and payer attestation programs. Every healthcare organization is expected to review potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI).
Our compliance program includes an annual SRA. We don't just generate a checklist; we provide a detailed summary report, identify gaps, and recommend corrective actions to help you reduce risk and stay compliant. The SRA also serves as important documentation if your organization is ever audited.
What are the best practices for safeguarding patient data in a digital age?
Safeguarding patient data in the digital age requires a multifaceted approach that includes robust security measures, employee education, and compliance with regulatory frameworks.
- Healthcare organizations should conduct comprehensive risk assessments to identify vulnerabilities and implement measures such as encryption, firewalls, and intrusion detection systems to protect patient data.
- Regular software updates, secure backup systems, and reliable recovery processes are also crucial to ensure data integrity.
- Additionally, organizations should establish clear policies for data handling and sharing, and train employees on these policies to minimize human error.
- Implementing access controls, such as role-based access and multi-factor authentication, can further reduce the risk of unauthorized access.
By adopting these best practices, healthcare organizations can significantly enhance the security of patient data and maintain compliance with regulations like HIPAA.
How can healthcare organizations protect against ransomware and other cyber threats?
Healthcare organizations can protect against ransomware and other cyber threats by implementing robust cybersecurity measures. This includes conducting regular vulnerability assessments and penetration testing to identify weaknesses in their systems. Implementing advanced security tools, such as intrusion detection systems and antivirus software, can help detect and prevent cyberattacks.
Furthermore, organizations should establish incident response plans to quickly respond to security incidents and minimize the impact of a breach. Employee education and training are also essential to prevent human error, which is a common entry point for cybercriminals. Healthcare organizations can reduce the risk of ransomware and other cyber threats by adopting a proactive approach to cybersecurity.
What are the legal implications of social media use for healthcare providers, and how can we mitigate risks?
The legal implications of social media use for healthcare providers are significant, as they must comply with regulations like HIPAA and maintain patient confidentiality. Healthcare providers should establish clear social media policies that outline appropriate use and ensure that employees understand the risks of sharing patient information online. Implementing training programs and regular audits can help mitigate risks and ensure compliance.
This cannot be stressed enough: Healthcare providers must be aware of the potential for cyber-attacks/data breaches through social media platforms and take steps to protect their online presence. HCP recommends a cautious approach to social media usage so healthcare providers can minimize legal risks and maintain patient trust.
How should organizations handle data breaches and notify affected patients in compliance with HIPAA?
Under HIPAA, covered entities and business associates are required to have a clear process for identifying, documenting, and responding to data breaches. Here's what that involves:
-
Investigate quickly: As soon as a potential breach is suspected, you must investigate to determine what happened, what data was involved, and how many individuals were affected.
-
Document findings: Keep detailed records of the incident, including how it was discovered, actions taken, and the outcome.
-
Notify affected individuals: If the breach involves unsecured protected health information (PHI), you must notify affected patients without unreasonable delay and no later than 60 days after discovery. Notices must be written in plain language and explain what happened, what information was involved, and what patients can do to protect themselves.
-
Notify regulators and, in some cases, the media: For breaches affecting 500 or more individuals, you must notify the U.S. Department of Health and Human Services (HHS) and local media outlets. Smaller breaches must still be logged and reported to HHS annually.
-
Mitigate and prevent future breaches: Implement corrective actions to reduce the risk of recurrence, such as updating policies, retraining staff, or strengthening security safeguards.
Having a breach response plan in place and training your team on it is critical for HIPAA compliance and for maintaining patient trust.
With HCP, you don't have to navigate this alone. We help clients log and track breaches, prepare compliant notification letters, and document corrective actions, so your organization is ready to respond quickly and confidently.
What are the key elements of a comprehensive cybersecurity policy for healthcare organizations?
A strong cybersecurity policy protects electronic protected health information (ePHI), safeguards patient trust, and keeps your organization compliant with HIPAA's Security Rule. Key elements include:
-
Access Controls - Ensure only authorized staff can access ePHI, with unique user IDs, secure passwords, and role-based permissions.
-
Risk Analysis & Management - Conduct regular security risk analyses (SRAs) and implement safeguards to reduce identified vulnerabilities.
-
Data Encryption - Encrypt ePHI both in transit and at rest to protect against unauthorized access.
-
Incident Response Plan - Establish clear procedures for detecting, reporting, and responding to security incidents or breaches.
-
Audit Logs & Monitoring - Track system activity to identify suspicious behavior and maintain compliance documentation.
-
Device & Network Security - Apply firewalls, antivirus tools, secure configurations, and timely software updates.
-
Training & Awareness - Provide ongoing staff training on phishing, secure data handling, and emerging threats.
-
Vendor Management - Ensure business associates meet HIPAA requirements through contracts and regular oversight.
Together, these elements create a layered defense strategy that helps healthcare organizations prevent, detect, and respond to cybersecurity threats while maintaining compliance.
With HCP, you also gain expert guidance, automated tools, and ongoing policy updates so your cybersecurity program stays current and audit-ready.
What are the best practices for conducting a comprehensive Security Risk Analysis (SRA) to identify potential vulnerabilities?
Best practices for conducting a comprehensive SRA include:
1. Identifying potential vulnerabilities: Conducting a thorough risk assessment to identify potential vulnerabilities in the organization's systems and processes.
2. Evaluating the likelihood and impact of each vulnerability: Assessing the likelihood and potential impact of each identified vulnerability.
3. Prioritizing and mitigating risks: Prioritizing and mitigating the identified risks based on their likelihood and potential impact.
4. Implementing security measures: Implementing security measures to address the identified vulnerabilities.
5. Regularly reviewing and updating the SRA: Regularly reviewing and updating the SRA to ensure that it remains comprehensive and effective.
How can healthcare organizations ensure compliance with the latest OCR guidance on patient privacy and data breaches?
The Office for Civil Rights (OCR) regularly issues guidance to clarify how healthcare organizations should protect patient privacy and respond to data breaches under HIPAA. To stay compliant, organizations should:
-
Monitor OCR updates - Assign responsibility for tracking new guidance and incorporating it into your compliance program.
-
Update policies and procedures - Revise your HIPAA privacy and security policies to reflect the latest expectations.
-
Conduct regular risk analyses - Review vulnerabilities to ePHI and document corrective actions, especially when OCR guidance highlights new areas of concern.
-
Train staff promptly - Provide updated training so employees understand how new requirements impact their daily work.
-
Maintain breach response readiness - Have clear, documented procedures for investigating, reporting, and notifying patients of breaches.
-
Document everything - Regulators look for proof of compliance, not just intent. Keep thorough records of policies, training, and incident response activities.
HCP helps make this process seamless by monitoring OCR guidance for you, updating your policies, training your staff, and documenting every step so you can demonstrate compliance and focus on patient care.
How can healthcare providers ensure their telehealth services remain HIPAA compliant in 2025?
Telehealth continues to expand, and regulators expect providers to safeguard patient privacy and secure electronic protected health information (ePHI) just as they would during in-person visits. To remain HIPAA compliant in 2025, healthcare providers should:
-
Use HIPAA-compliant platforms - Choose telehealth technology that provides end-to-end encryption, secure login, and a signed Business Associate Agreement (BAA).
-
Update policies and procedures - Incorporate telehealth-specific guidelines into your HIPAA policies, including how staff should verify patient identity, share information, and document visits.
-
Secure devices and networks - Ensure both provider and patient connections are encrypted, and require staff to use organization-approved devices with updated security patches.
-
Train staff regularly - Provide role-based training on telehealth privacy, cybersecurity best practices, and patient communication standards.
-
Maintain proper documentation - Keep records of telehealth encounters, policies, and risk assessments to demonstrate compliance if audited.
-
Conduct annual Security Risk Analyses (SRAs) - Include telehealth workflows in your SRA to identify vulnerabilities unique to remote care.
With HCP, you don't have to figure this out on your own. We provide updated HIPAA policies, training, and risk assessments designed for telehealth, so your organization can adapt quickly to changing requirements while protecting patients and staying audit-ready.
A healthcare provider is required by state law to offer patients one free copy of their medical records, but HIPAA allows the provider to charge a fee. Does HIPAA supersede State law?
No, in this scenario, the health care provider must abide by state legislation and provide the one complimentary copy. HIPAA does not supersede State laws that give people more access rights to their health information than the HIPAA Privacy Rule does, in contrast to State laws that authorize fees that are higher or different than those allowed under HIPAA (See 45 CFR 160.202 and 160.203).
"This includes State laws that: (1) prohibit fees to be charged to provide individuals with copies of their PHI; or (2) allow only lesser fees than what the Privacy Rule would allow to be charged for copies." - HHS
When a covered entity uses a patient's payment of the permitted charge for a copy of their PHI to settle an unpaid bill for services rendered, can a health care provider refuse to give the patient the copy even though the patient requested it?
No, just as a covered entity cannot refuse or withhold access to a person's PHI on the grounds that the person has not paid the bill for the medical services the covered entity rendered to them, neither can a covered entity refuse or withhold access on the grounds that the person's payment of the fee for a copy of his PHI was used to settle or cover the person's unpaid medical bill.
What are the stages of a record?
The lifecycle of a record includes four basic steps:
- Creation - Once a document is completed, it becomes a record. At this point, it enters the records management cycle.
- Active use - When in active use, records are stored in file folders if they are paper-based, electronically in files on a computer system if they are electronic, or filed on microfilm or other recording media for regular use. As most records age, they are referred to less often. When records reach the time that they are referred to less often than once every six months, they should be moved to less costly storage.
- Inactive use - When records become inactive, they are normally boxed if in paper form or achieved electronically to a CD or magnetic tape. Inactive storage is considerably less expensive than active storage and frees up space for active storage of more active records.
- Disposition - The final step in the life cycle of a record is its final disposition. This can mean simple destruction by throwing it in a waste can or have the record shredded or incinerated. Some records should not be destroyed, and they need to have a way to be identified and stored for very long time periods.
When someone just asks to see her PHI at a covered entity without asking the covered organization to create a copy of the PHI, can they still be assessed a fee?
No. Fees for persons who exercise their right to access their PHI are only applicable when such individuals are receiving a copy of their PHI rather than just having the option to view and inspect it. In addition to requiring covered businesses to arrange for a suitable time and location for the individual to view their PHI, the HIPAA Privacy Rule gives individuals the right to inspect their PHI maintained in a specified record set. See § (1) and § (2) of 45 CFR 164.524.
As a result, covered entities must set up appropriate processes that allow individuals to view their PHI. Requests for inspections should also result in the least amount of extra work on the part of the entity, especially if the PHI is the kind that can be readily accessed on-site by the entity during regular business hours. If the persons consent to the use of this functionality, covered entities may, for instance, utilize Certified EHR Technology (CEHRT) to allow individuals to inspect their PHI.
Furthermore, a covered entity is not allowed to charge someone who makes notes, takes pictures of her PHI using a smartphone or other device, or uses other personal resources to record the information while viewing her PHI. The covered entity may not charge a fee for copies of PHI that the individual makes using her own resources since she is the one creating the copies, not the entity. To ensure that an individual's use of her own camera or other device for copying PHI does not interfere with the entity's operations and is used in a way that allows her to copy or otherwise memorialize only the records to which she is entitled, a covered entity may set reasonable policies and safeguards. Furthermore, connecting a personal device to a covered entity's systems is not a requirement for the covered entity.
Is it possible for a person's personal representative to request that their health care provider or health plan communicate their personal health information to a third party under the HIPAA right of access?
Indeed. A person's personal representative, typically someone authorized by state law to make health care decisions on the person's behalf—has the right to obtain a copy of PHI about the person in a designated record set and to instruct the covered entity, in accordance with the parameters of such representation and 45 CFR 164.524 requirements, to forward a copy of the PHI to another individual or entity upon request. 45 CFR 164.502(g) is cited. Those made by an individual's personal representative must meet the same standards as those made by the individual to communicate the individual's PHI to a third party (e.g., regarding timeliness, form and format, basis for refusal, fee limitations, etc.).
When a person requests access to their PHI, what obligations does a covered entity have when replying to their request?
For the purpose of confirming that the designated third party is an authorized receiver, covered organizations may rely on the written information supplied by the individual regarding the name of the designated person and the address to which to send the PHI. Covered entities must, however, put adequate safeguards in place before fulfilling the request in any other way.
For example, they must take reasonable measures to confirm the identity of the person submitting the access request and to ensure that the right data is entered into the covered entity's system. For instance, a covered organization must have reasonable procedures in place to guarantee that the supplied email address is accurately entered into the covered entity's system, even though the covered entity is not required to verify that the person submitted the third party's proper email address.
Moreover, covered entities are accountable for breach reporting, must protect PHI while it is in transit, and may be held accountable for any unauthorized disclosures of PHI, except in the specific circumstances outlined below. The only exception is when a person, who has the right to request it, asks for the PHI to be communicated to a third party via unencrypted email or in another insecure way. The covered entity is exempt from breach reporting obligations and liability for disclosures made during transmission as long as the individual was informed of and consented to the security risks to the PHI connected with the insecure transfer.
Furthermore, after the selected third party receives the information as instructed by the individual in the access request, the covered entity is not responsible for what happens to the PHI.
What is a covered entity's responsibility under theBreach Notification Rule if it sends a person's PHI to a third party that theperson designates access to and later finds out the data was compromised intransit?
In general, a covered entity must notify the individual and HHS of the breach and otherwise comply with the HIPAA Breach Notification Rule at 45 CFR 164, Subpart D, if it finds that the PHI was compromised while it was being transferred to the designated third party and that the PHI was "unsecured PHI" as defined at 45 CFR 164.402. The covered entity is not liable for any disclosure of PHI to the designated third party while it is being transmitted, including any breach notification obligations that would otherwise be necessary, if the individual requested that the PHI be transmitted in an insecure manner (such as unencrypted) and she maintained her preference to have the PHI sent in that manner after being informed of the security risks to the PHI associated with the insecure transmission. Furthermore, after the information is sent to the authorized third party under the requester's instructions, a covered business is not responsible for what happens to the PHI.
The covered entity is exempt from reporting requirements under the Breach Notification Rule if the compromised PHI is "secured" in accordance with the guidelines in the HHS Guidance Specifying the Technologies and Methodologies that Render Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals (accessible at https://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html).
How long do HIPAA-related medical records need to be retained?
HIPAA regulations require that all HIPAA-related records and documents be retained for six (6) years. This applies to authorizations, audit records, business associate agreements, and contracts, etc. They may then be destroyed in a manner that does not allow for the disclosure of any PHI (e.g., burning, shredding, etc.).
What should be included in a well-documented medical record?
A properly documented medical record should:
- Be complete and legible
- Include the reason for the encounter, any relevant history, physical examination findings, prior diagnostic test results, assessment, clinical impressions or diagnosis, plan for care, the date, and identity of the observer
- Include the rationale for ordering diagnostic and other ancillary services
- Support the CPT and ICD-10-CM codes used for claims submission
- Identify appropriate health risk factors
- Document the patient's progress, response to or changes in treatment, or any revision in diagnosis
Where should the signed release of information and assignment of benefits forms be kept?
All patients must sign a release of information and assignment of benefits form before they receive services. These forms should be placed in the patient's chart or record after the patient and/or the responsible party signs them. There are strict rules regarding the assignment and reassignment of billing rights in both Medicare and Medicaid programs.
What does the 21st Century Cures Act provide?
The 21st Century Cures Act, passed in 2016, is a wide-ranging law designed to accelerate medical research and innovation, improve patient access to their health information, and strengthen mental health and substance use disorder services. For healthcare organizations, one of the most important impacts is the Information Blocking Rule, which requires providers, health IT developers, and payers to give patients easy, secure access to their electronic health information (EHI).
Key provisions include:
-
Patient access to records - Patients have the right to access their medical records electronically without unnecessary delays or fees.
-
Information sharing - Healthcare providers and vendors must not "block" or unreasonably restrict the exchange of health data.
-
Interoperability - Encourages the use of standardized APIs and technology that make it easier to share health data across systems.
-
Research and innovation - Provides funding for biomedical research, precision medicine, and faster drug and device approval processes.
-
Mental health and opioid response - Expands programs to address behavioral health and substance use disorders.
For compliance teams, the Cures Act means organizations must review their policies, patient portals, and EHR practices to ensure patients can access their information quickly and without unnecessary barriers.
HCP helps healthcare organizations adapt to these requirements by updating policies, training staff, and documenting compliance so you can support patient rights and avoid penalties.
What is the Preventing Harm Exception?
The Preventing Harm Exception is part of the Information Blocking Rule under the 21st Century Cures Act. While the law generally requires healthcare providers to give patients access to their electronic health information (EHI) without unnecessary delay, there are limited situations where access can be restricted.
The Preventing Harm Exception allows a provider to withhold access to EHI if releasing the information is reasonably likely to cause harm to a patient or another person. For example, if a provider believes that immediate access to certain mental health records could cause substantial harm to a patient's well-being, they may delay or limit disclosure.
Key points include:
-
The decision must be based on professional judgment, not convenience.
-
The potential harm must be physical harm or a substantial risk of harm, not just embarrassment or upset feelings.
-
Providers must document the reason for withholding information and apply the exception consistently and narrowly.
-
The exception is not meant to be a loophole—its use is closely scrutinized by regulators.
In practice, healthcare organizations should have policies and training in place so staff know when and how the Preventing Harm Exception can be applied and how to document it properly. HCP helps clients update their policies and educate staff on these nuanced requirements.
If I don't have an EHR, do I have to conduct an SRA?
Yes, an accurate and thorough SRA includes ALL ePHI that is created, received, maintained, or transmitted. This includes billing systems, cloud storage, email applications, copy and fax machines, personal devices such as smartphones, laptops, tablets, and any electronic media involving ePHI. So, even if a healthcare organization doesn't use an EHR, there are most likely other locations where ePHI is stored, meaning an SRA should still be conducted.
What is best practice and how often should vulnerability scans and penetration tests be run?
HIPAA does not require vulnerability scans or penetration testing to be performed on a specific timeline. It should be based on the specific needs of the covered entity or business associate. If your organization is looking to maintain a high level of security, vulnerability scanning needs to be added to your information security program. Vulnerability scans should be conducted after any major system, organization, or infrastructure change to ensure you're aware of any security gaps. Overall, an industry best practice is to perform vulnerability scanning at least once per quarter. Quarterly vulnerability scans tend to catch any major security holes that need to be assessed, but depending on your unique organizational needs, you may end up performing scans monthly or even weekly. The best way to assess vulnerability scanning frequency is to thoroughly understand your own security structure and the threats you face.
OSHA
What are the new OSHA regulations for 2024 that healthcare organizations need to be aware of?
Organizations need to be aware of several new OSHA regulations that aim to enhance workplace safety and reduce the risk of injuries and illnesses. These regulations include expanded electronic submission requirements, new requirements for injury and illness recordkeeping, and a nationwide emphasis program for warehouse and distribution center operations. Healthcare organizations must ensure they understand and comply with these regulations to avoid penalties and maintain a safe work environment.
What are the best practices for maintaining an effective OSHA compliance program?
Organizations can prepare for an unexpected OSHA inspection by:
1. Designating a compliance officer: Designate a compliance officer to serve as the primary point of contact during an OSHA inspection.
2. Maintaining accurate and up-to-date records: Ensure that all records, including OSHA 300 logs and hazard assessments, are accurate and up-to-date.
3. Conducting regular self-audits: Conduct regular self-audits to identify and address potential hazards and compliance issues.
4. Developing an OSHA inspection protocol: Develop an OSHA inspection protocol to ensure that employees know what to expect and how to respond during an inspection.
5. Regular workforce training is needed: Provide training to employees on OSHA regulations and workplace safety, as well as how to respond during an inspection.
How should healthcare facilities conduct a comprehensive workplace hazard assessment?
Conducting a comprehensive workplace hazard assessment in healthcare facilities involves several critical steps. Initially, it's essential to identify potential hazards across various categories, including physical, chemical, biological, and psychological risks. Once identified, each hazard's likelihood and potential impact should be thoroughly evaluated. This evaluation helps prioritize which hazards need immediate attention and mitigation. Implementing appropriate controls and preventive measures is crucial to effectively minimizing the identified risks. Additionally, regular reviews and updates of the hazard assessment are necessary to ensure its continued relevance and effectiveness in addressing new and emerging threats. By following these steps, healthcare facilities can create a safer working environment for their employees.
How can organizations prepare for an unexpected OSHA inspection?
The key components of an effective workplace safety training program for healthcare employees include:
- OSHA regulations and compliance: Training on OSHA regulations and compliance requirements.
- Workplace hazards and risk management: Training on identifying and managing workplace hazards and risks.
- Emergency response and preparedness: Training on emergency response and preparedness, including fire safety, evacuation procedures, and more.
- Personal protective equipment (PPE) and safety protocols: Training on the proper use of PPE and safety protocols, such as infection control and bloodborne pathogen protocols.
- Regular refresher training and updates: Regular refresher training and updates to ensure that employees remain knowledgeable and competent in workplace safety and OSHA regulations.
Do you provide Global Harmonization (GHS) transitioning and training?
Yes. OSHA adopted the Globally Harmonized System (GHS) for classifying and labeling chemicals, which means healthcare organizations must use standardized Safety Data Sheets (SDS) and train employees on the new labeling requirements. Transitioning to GHS ensures that chemical hazards are communicated consistently and clearly across all industries.
We provide training to help your staff understand the GHS labeling system, SDS requirements, and how to handle hazardous chemicals in the workplace safely. We also support you in maintaining an up-to-date, fully managed virtual SDS binder, so your organization stays OSHA compliant and your employees stay protected.
Corporate Compliance
How can healthcare organizations detect and prevent fraud, waste, and abuse?
Detecting and preventing fraud, waste, and abuse in healthcare organizations requires a multi-faceted approach. At the core lies a robust compliance program emphasizing regular training, monitoring, and auditing of operational activities. This proactive stance empowers employees to identify potential risks and vulnerabilities within the organization's systems and processes. However, merely having a compliance program is not enough. Healthcare organizations must leverage advanced data analytics and machine learning algorithms to uncover suspicious patterns and anomalies that may indicate fraudulent activities. These sophisticated tools and a confidential reporting system for employees to voice concerns without fear of retaliation create a comprehensive defense against fraud, waste, and abuse. Ultimately, fostering a culture of transparency and collaboration with law enforcement agencies is crucial to staying ahead of ever-evolving schemes and sharing best practices in fraud prevention.
What are the latest guidelines from the OIG regarding corporate compliance and fraud prevention?
The Office of Inspector General (OIG) has developed guidelines for corporate compliance and fraud prevention, including:
Seven Fundamental Elements of an Effective Compliance Program:
- View the OIG's PDF Guide here: "The Seven Fundamental Elements of an Effective Compliance Program." (https://oig.hhs.gov/documents/provider-compliance-training/945/Compliance101tips508.pdf)
General Compliance Program Guidance:
- The General Compliance Program Guidance (GCPG) is a reference guide for healthcare professionals and other stakeholders. The GCPG provides information on pertinent federal legislation, compliance program architecture, OIG tools, and other information that might help you understand health care compliance.
- The GCPG is a voluntary guideline that outlines broad compliance risks and compliance initiatives. The GCPG is not legally obligatory on any individual or corporation. Notably, the OIG utilizes the word "should" in the GCPG to give voluntary, nonbinding guidance.
- For more information, view the OIG's guide here: "General Compliance Program Guidance (GCPG)." (https://oig.hhs.gov/compliance/general-compliance-program-guidance/)
How should organizations handle whistleblower reports and ensure confidentiality?
Organizations must treat whistleblower reports with the utmost seriousness and confidentiality to foster an environment where employees feel safe to report misconduct without fear of retaliation. This begins with establishing a secure and anonymous reporting system, managed by a designated compliance officer who is trained to handle such sensitive information discreetly.
Upon receiving a report, the compliance officer should initiate a prompt and thorough investigation to address the alleged misconduct. Throughout this process, it is crucial to maintain the confidentiality of the whistleblower to protect them from any potential retaliation.
Additionally, organizations should keep detailed documentation of all reports and the subsequent actions taken, not only to ensure accountability but also to monitor the effectiveness of the compliance program in identifying and mitigating risks.
What are the consequences of non-compliance with the False Claims Act?
Non-compliance with the False Claims Act (FCA) carries severe consequences for healthcare organizations, including substantial civil penalties for each false claim filed, and in egregious cases, criminal charges. Organizations may also face exclusion from participating in federal healthcare programs, which can have a devastating impact on their operational consistency and brand reputation. Suffice it to say that non-compliance will always be the most costly option.
How can an organization minimize these risks?
The only certain protection against legal scrutiny is effective compliance with good faith effort documentation.
To minimize risk, organizations can:
- Implement an effective compliance program: Establishing effective compliance programs that include regular training, monitoring, and auditing.
- Conduct regular risk assessments: Identifying potential risks and vulnerabilities in the organization's systems and processes.
- Implement fraud detection tools: Utilizing data analytics and machine learning algorithms to identify suspicious patterns and anomalies.
- Respond to law enforcement as soon as possible and collaborate: Working with law enforcement agencies to share information and best practices in fraud prevention.
How long do the Centers for Medicare & Medicaid Services (CMS) require healthcare providers and organizations to retain patient records for?
CMS requires healthcare providers and organizations to retain patient records for Medicare beneficiaries for at least five (5) years. CMS requires Medicare managed care program providers to retain records for ten (10) years.
If fraudulent behavior is reported through the compliance hotline, does it need to be reported to a government agency?
The purpose of a compliance hotline is to provide an anonymous way for individuals to report "suspected" fraudulent behavior. When the report comes in, it is just a report. It must be investigated by the organization. If found to be true, then the organization should determine next steps for dealing with the fraudulent behavior. It could include self-reporting and potentially paying back claims. This decision is typically made by the organization with the guidance of legal counsel.
Is Corporate Compliance training only required if the organization is contracted with Medicare?
No. As part of participation in any federal payment program, like Tricare or Medicaid, a provider is required to have an effective corporate compliance program. Part of an effective program includes corporate compliance training. Additionally, many payors are contractual obligated to ensure that all of their FDRs maintain a corporate compliance program. Healthcare providers would be considered an FDR and therefore would be required by their contracts with payors to have a compliance program which includes training.
It's a good idea for our clients who think they don't have to have a corporate compliance program in place to check their payor contracts to see exactly what is required of them and if a corporate compliance program with training is a requirement of their payors. The only time that a corporate compliance program is certain to not be required is if the provider only accepts cash-paying patients.
Cultural Competency & Equity
What are the best practices for promoting cultural competence in healthcare settings?
Promoting cultural competence in healthcare settings requires a multifaceted approach. Education and training are essential for healthcare professionals to improve their understanding and skills in working with diverse populations. Culturally sensitive communication is critical, recognizing the complexity of language interpretation and facilitating learning between providers and communities. A diverse workforce that reflects the patient population can also improve patient-provider interactions and satisfaction. Additionally, offering culturally and linguistically appropriate services that respond to individual preferences and needs is crucial. Community engagement and involvement in defining and addressing health disparities are also vital components of promoting cultural competence.
How can healthcare providers improve patient engagement and satisfaction among diverse populations?
Healthcare providers can significantly improve patient engagement and satisfaction among diverse populations by delivering culturally competent care that respects and integrates patients' cultural beliefs and values. This involves developing tailored treatment plans that address individual needs and preferences and fostering a patient-centered approach that considers patients' perspectives and values. By facilitating cross-cultural communication, healthcare providers can enhance patient understanding and build trust.
Addressing health disparities by recognizing and tackling differences in healthcare access and outcomes is crucial. By creating an inclusive environment where diverse cultural backgrounds are acknowledged and respected, healthcare providers can ensure that all patients feel valued and understood, leading to higher levels of engagement and satisfaction.
What are the key components of an effective cultural competence training program?
Key components of an effective cultural competence training program include:
- Cultural Awareness: Educating healthcare professionals about their own cultural biases and assumptions.
- Cross-Cultural Skills: Teaching cross-cultural communication and interaction skills.
- Cultural Knowledge: Providing knowledge about diverse cultural backgrounds and health beliefs.
- Practice and Feedback: Offering opportunities for practice and feedback to improve cultural competence.
- Organizational Support: Ensuring organizational support and commitment to cultural competence.
How can organizations assess and address health disparities within their patient population?
There are five key areas for any organization to assess and address health disparities within its patient population by:
- Data Analysis: Analyzing data to identify disparities in healthcare access and outcomes.
- Community Engagement: Engaging with the community to understand their needs and preferences.
- Cultural Competence Training: Providing cultural competence training for healthcare professionals.
- Language Access Services: Ensuring language access services are available to address language barriers.
- Quality Improvement Initiatives: Implementing quality improvement initiatives to address disparities and improve health outcomes.
For more information, check out HCP's blog about "Cultural Competency Rules: What Health Providers Must Know Going Forward" here: (https://www.healthcarecompliancepros.com/blog/cultural-competency-rules-what-health-providers-must-know-forward)
I have heard the terms "cultural competence," "cultural humility," and "cultural responsiveness." Do these words mean the same?
As in any field or topic of discussion, you can articulate multiple words that mean similar ideas from subtle perspectives, and that is the case with these three terms.
- Cultural competence implies that one can meet the needs of culturally diverse clients. Perhaps a person might shy away from the term's use because of a misconception: you either have or do not have the skills (i.e., that one can actually "arrive," so to speak). However, a person does not arrive at cultural competence. Instead, a individual can find instructive exposure to diverse cultures, having conversations, routinely discussing diversity, and learning new skills may help us appreciate the perspectives of culturally distinct people.
- Cultural humility is the awareness that working with culturally diverse individuals may require experts who understand a specific culture and thought processes. An individual can remain humble by allowing these experts to help guide this process. This does not mean the practitioner knows nothing. Instead, the practitioner engages each family as unique, from a strengths perspective, and allows for mutual learning toward a common goal: inclusive care.
- Cultural responsiveness helps people learn about culture, ethnicity, and language. The key difference is "responsiveness," which does not imply that one can be perfect and have attained all the skills and views needed to work with culturally diverse clients. It assumes one has the openness to adapt to the cultural needs of those with whom they work.
Are cultural competence trainings the way to ensure that my organization is culturally competent?
Cultural competence is an ongoing developmental process. While cultural competence trainings serve as a good means to increase provider knowledge, skills, and awareness, it is insufficient in and of itself to make your organization culturally competent. Cultural competence trainings work best when they exist within a complete framework that supports it, such as, but certainly not limited to:
- The existence of policies that ensure equitable hiring practices;
- An environment that is welcoming to those of different cultures (e.g., pictures and brochures that have people of different ethnicities or types of families);
- Connections with cultural resources in the community.
What is my role as administrator in working towards cultural competence?
As an administrator, you can work to ensure cultural competence in a variety of ways. However, it is important that you see yourself as part of the change process. It does little good to schedule cultural competence trainings for your staff, if you and other administrators do not attend these trainings. You are a cultural being, and as such, you are also prone to bias. Increasing your knowledge, skills, and awareness will help you better scrutinize practices in your organization to ensure that bias does not exist. It also supports your role as a leader and change agent. In addition, your attendance at these workshops also shows your staff how much you care about the ideas of cultural competence. There are other means of working towards cultural competence. Your attendance at trainings alone will not do the trick. You can:
- Avail yourself of resources on cultural competence
- Regularly assess cultural competence on both the practitioner and organizational level
- Include items that assess progress towards becoming culturally competent in staff evaluations
- Include cultural competence in your strategic plan
- Enact policies that make cultural competence a priority
- Recruit staff that is representative of the population you serve
- Reward & incentivize personal and professional attempts at becoming more culturally competent • Engage your staff in regular discussions about diversity • Consider culture in treatment planning and staff meetings • Form relationships with cultural brokers/liaisons/resources in your community and seek their expertise when in doubt • Evaluate whether or not there are barriers to service provision based on cultural preference for treatment options
There are many things that can be done at the level of administration. This list is not exhaustive, but will definitely point you in the right direction.
What is ethnicity? How is it different from race?
Ethnicity and race are often spoken about interchangeably, but they are not the same. Ethnicity refers to one's ethnic culture; the vast structures of behaviors, ideas, values, habits, rituals, ceremonies, and practices common to a particular group of people that provides them with a general design for living and patterns for interpreting reality. Conversely, race is a fictitious construct. There is no biological basis for race. That being said, when we say, "Race," we typically are identifying people by skin color; black, white, Asian or Indian. Race, or skin color, is not a way to identify ethnicity or culture. One can be a black American or a white American. As well as one can be a black Trinidadian or an Indian Trinidadian; a white Puerto Rican or a black Puerto Rican. The two often intersect.
What are the typical areas in which there will be cross-cultural differences?
Kevin Avruch and Peter Black, who primarily work from the business relations' perspective, outline six fundamental patterns of cross-cultural differences:
- Communication styles
- Attitudes towards conflict
- Approaches to completing tasks
- Decision making styles
- Attitudes towards disclosure
- Approaches to knowing
A simple Google search for these authors will yield detailed, insightful information with definitions and examples of what these differences mean as well as what they look like. However, as it pertains to mental health, there will be more differences, such as; differences in the ways in which we describe these issues (some cultures have a limited vocabulary for emotion words, and the notion of "mental illness," does not exist), differences in what we think causes these issues ("God must be mad with us," "She is being punished for her early promiscuity," etc.), and differences in the ways we think we should go about solving these problems (individual therapy, medication management, prayer, reiki, chi gong, meditation, etc.).
Why does cultural competence matter?
Cultural competence is essential for a few reasons. The first major reason is because we live in a diverse society. We are diverse with respect to race/ethnicity, social class, gender, sexual orientation, ability, age and religion/spirituality. It should not be assumed that any perspective is better than the other. Each perspective is valid. Despite this truth, those who have traditionally been in positions of power have made rules and policies that are reflective of their cultural points of view, without realizing that they look at the world from a particular cultural lens. This unintentional bias has resulted in such things as the overrepresentation of African American and Hispanic groups in prison, juvenile detention, special education and foster care. In addition, these and other ethnic minority groups have been underrepresented in less punitive, treatment-oriented systems such as mental health and inpatient facilities.
We talk about ethnicity a lot, are there other culture or diversity issues we should be aware of?
How does OSHA define a recordable injury or illness?
- Any work-related fatality.
- Any work-related injury or illness that results in loss of consciousness, days away from work, restricted work, or transfer to another job.
- Any work-related injury or illness requiring medical treatment beyond first aid.
- Any work-related diagnosed case of cancer, chronic irreversible diseases, fractured or cracked bones or teeth, and punctured eardrums.
- There are also special recording criteria for work-related cases involving: needlesticks and sharps injuries; medical removal; hearing loss; and tuberculosis.
How does OSHA define first aid?
- Using a non-prescription medication at nonprescription strength (for medications available in both prescription and non-prescription form, a recommendation by a physician or other licensed health care professional to use a non-prescription medication at prescription strength is considered medical treatment for recordkeeping purposes);
- Administering tetanus immunizations (other immunizations, such as Hepatitis B vaccine or rabies vaccine, are considered medical treatment);
- Cleaning, flushing or soaking wounds on the surface of the skin Using wound coverings such as bandages, Band-Aids™, gauze pads, etc.; or using butterfly bandages or Steri-Strips™ (other wound closing devices such as sutures, staples, etc., are considered medical treatment);
- Using hot or cold therapy;
- Using any non-rigid means of support, such as elastic bandages, wraps, non-rigid back belts, etc. (devices with rigid stays or other systems designed to immobilize parts of the body are considered medical treatment for recordkeeping purposes);
- Using temporary immobilization devices while transporting an accident victim (e.g., splints, slings, neck collars, back boards, etc.). Drilling of a fingernail or toenail to relieve pressure, or draining fluid from a blister;
- Using eye patches;
- Removing foreign bodies from the eye using only irrigation or a cotton swab;
- Removing splinters or foreign material from areas other than the eye by irrigation, tweezers, cotton swabs or other simple means;
- Using finger guards;
- Using massages (physical therapy or chiropractic treatment are considered medical treatment for recordkeeping purposes); or
- Drinking fluids for relief of heat stress.
What is the HIPAA Breach Notification Rule?
The Breach Notification Rule says that covered entities and business associates must tell affected patients, HHS, and the media when there is a breach of PHI. You must notify authorities of most breaches without reasonable delay and no later than 60 days after discovering the breach. Submit notifications of smaller breaches affecting fewer than 500 patients to HHS annually.
Most of the time, a HIPAA breach is an unauthorized use, transmission, or disclosure of PHI that compromises its security or privacy. If PHI is used or shared without permission, this is a breach, unless a risk assessment shows that there is a low chance that the PHI has been compromised. The severity of a breach incident are determined by factors including, but are not limited to:
- The nature and extent of the PHI involved (i.e., the types of identification or the chances of re-identification)
- The unauthorized person who used the PHI or got the disclosed PHI
- Whether an individual acquired or viewed the PHI
- The extent to which you reduced the PHI risk
HIPAA requirements detail how a covered entity and business associate can handle protected health information (PHI). When a covered entity discovers a breach of unsecured PHI, the Department of Health and Human Services (HHS.gov) sets different recordkeeping and notification requirements depending on the severity of the incident.
Learn more specific information about "Submitting Notice of a Breach to the Secretary" here: (https://www.hhs.gov/hipaa/for-professionals/breach-notification/breach-reporting/index.html)
What if a PHI breach incident affects 500 or moreindividuals?
The HIPAA Breach Notification Rule outlines the requirements
for breach incidents affecting 500 or more individuals. A covered business must
notify the Secretary within 60 days of discovering a breach of unsecured
protected health information (PHI) affecting 500 or more individuals. The
covered entity must submit the breach notification form electronically and fill
out all essential fields of the breach notification form.
View a list of breaches affecting 500 or more individuals on
OCR Portal here: (https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf)
What if a PHI breach incident affects fewer than 500 individuals?
For breaches that affect fewer than 500 individuals, a covered business shall notify the Secretary within 60 days of the end of the calendar year in which a breach of unsecured protected health information (PHI) affects fewer than 500 people. A covered entity can report breaches impacting fewer than 500 people at the moment they are detected. The covered company may notify all breaches impacting fewer than 500 people on one date, but each breach incidence must be reported separately. The covered entity must fill out the breach notification form to submit the notice electronically.
Who enforces HIPAA rules and regulations?
The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) is a primary enforcement agency for rules set within the Health Insurance Portability and Accountability Act (HIPAA). The aim is for safeguards that ensure the privacy and security of protected health information (PHI).
Who must comply with HIPAA rules?
Covered entities and business associates must follow HIPAA rules. The goal is to protect the privacy and security of protected health information (PHI) and ensure a patients' right of access. Examples of a Covered Entity may include, but are not limited to:
A Healthcare Provider
- Doctors
- Clinics
- Psychologists
- Dentists
- Chiropractors
- Nursing Homes
- Pharmacies
A Health Plan:
- Health insurance companies
- Health Maintenance Organizations (HMO)
- Company health plans
- Government programs that pay for health care including Medicare, Medicaid, Military, and Veteren's health care programs
A Health Care Clearinghouse:
- Including establishments that process nonstandard health information received from another entity into a standard (i.e., data content or standard electron formats, or vice versa).
If you don't meet the definition of a covered entity or business associate, you don't have to comply with the HIPAA rules. For definitions of covered entities and business associates, see 45 CFR 150.103 (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.103)
Can biohazard specimen bags be reused if not visibly soiled?
Biohazard specimen transport bags should not be reused. Best practice and OSHA's recommendation is to dispose of each bag after use. Looking for visible contamination is not infallible because certain body fluids are colorless, meaning that although you may not see a spill, there is still the possibility of contamination. While the idea of reusing them to reduce waste is a valid one, the need for infection control precautions outweighs financial or excess trash considerations.
How long should autoclave results logs be kept?
We recommend following the CDC's guidelines as a best practice and retaining them for at least 3 years or as long as your state law requires if it is a longer timeframe. Healthcare providers may want to check with their local health department as well to see if there are local retention requirements.
Should a healthcare provider keep a log of biohazardous waste that is collected from them for disposal?
Yes, we recommend maintaining a log of when the hazardous waste is collected and removed from a healthcare provider's facility in addition to when they received the manifest that it was destroyed. Additionally, federal regulations require providers to keep the manifest, along with the biohazardous waste log and any other pertinent documents related to the packaging, storage, transport, or disposal of the medical waste for at least 3 years. HCP has a sample log available for clients to use when tracking the removal of biohazard waste, along with the transporter and date the certification of destruction is received.
What is considered “regulated waste”?
OSHA's Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials (OPIM)
- items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or OPIM and are capable of releasing these materials during handling
- contaminated sharps
- pathological and microbiological wastes containing blood or OPIM.
Q What are the differences between personal and professional use on social media platforms?
Personal use of social media is often referred to as social media use on an account registered to an individual who is not used for business purposes. Professional use is generally using social media for approved business purposes on behalf of an account registered to an organization, practice, or provider.
Q Can organizations respond directly to patients who post comments or questions on social media?
When posting a response to a question, use limited information and suggest another communication method. If a patient asks you a question on a social media platform that could potentially lead to a disclosure of PHI, it would be best to suggest the patient contact you using another form, a more private form of communication. It is important to limit unnecessary or inappropriate access to and disclosure of PHI. Avoid accessing or discussing PHI that is not essential to the task at hand.
When posting on your personal social media account, if it is something you don't want the public to know or access, it is also a good idea to communicate with a private form of communication. This includes when sharing information in "private" groups.
Q What are the risks involved with making social media posts?
Whether you are posting on your own or a professional account, it is important to understand the potential risks.
Some risks include:
- Anything that is posted has a risk of receiving negative feedback from the public that could hurt the success of the business and its reputation.
- The accidental sharing of PHI, proprietary information, or other content that could be used by those with malicious intent from the post.
- Having a difficult time managing and/or responding to posts and comments from users. Organizations need to train employees on how to respond to negative or inaccurate statements made on their posts.
Q If your organization has a social media account for professional use, what should be included in a social media policy for employees?
You may have language in place in a social media policy that states if personal use of social media is or is not permitted during business hours. Your policy may also explain the professional help of social media on behalf of the organization, practice, or provider. In other words, who should post, who should update, what should be published, etc. We have a Social Media template available for customization for your organization. Ask your support team for access.
Q Can healthcare organizations post pictures?
Never post any photos involving patients without authorization! Even then, be extremely cautious and always have written authorization. When pictures or patient information are used for purposes other than Treatment, Payment, and Operations (TPO), a valid HIPAA authorization must be obtained from the patient or the patient's legally authorized representative. This includes when posting on social media. When in doubt, check with your compliance officer before posting anything that could be considered PHI.
What if we are a non-medical facility? Does HCP offer a compliance program that suits us?
Yes! HCP offers a program tailored for Non-Medical Facilities. We help you maintain compliance with the following areas: OSHA, Human Resources, and Learning Management System. Working with HCP means you no longer have to wonder if you comply with your industry requirements.
We are Business Associates. How can HCP help support us in our compliance journey?
HCP offers a Healthcare Business Associate Package. That package helps you maintain compliance as it applies to HIPAA, Corporate, Human Resources, and Learning Management Systems, with an optional Compliance Risk Analyzer.
With so many compliance programs out there, what sets HCP apart from its competitors?
With HCP, you get a
custom program tailored to meet your needs and have access to a dedicated
support team that is there to work with you every step of the way. With our
support team, you have a personally dedicated group to your facility. They are
consistently monitoring your program and reaching out to you with quarterly
updates to keep you informed on how you are doing and assist you with any areas
that need improvement. You also have the ability to meet with your support team
and discuss any questions or concerns that may arise. You will have their
direct phone numbers and email addresses. So please, reach out to them and you
will truly see the value of HCPs Compliance Services, and why our Support Team
is one of our best features!
How is our Employee Handbook incorporated into HCP online training?
Healthcare Compliance Pros provides your organization with HIPAA Privacy, HIPAA Security, Corporate Compliance, OSHA, and Human Resources policies and procedures. While these policies and procedures are a blanket set, meaning these policies and procedures ensure your organization follows Federal requirements; taking some time to add language specific to your organization is an important step. (The first step of our program is completing the Organization Questionnaire - we take your answers and incorporated them into the compliance training.)
How does HCP help us stay compliant?
Being Compliant is a process that does not need to be completed all at once and doesn't need to be complicated. Rather, it is an ongoing process that we will be working with you to complete. For example, when you submit a Security Risk Analysis (SRA), a big part of that process is discussing HIPAA Security Policies and Procedures - addressable and required. Most of the policies that are discussed in your SRA, in addition to HIPAA Privacy policies and procedures, are included in our training modules.
How often Does HCP update their training information?
Whether HIPAA, OSHA, Corporate Compliance, and/or Human Resources, the policies and procedures are always reviewed and updated, as necessary. These policies and procedures are always available wherever you have internet access, can be printed out as necessary, and provide a good way for your employees to complete their training.
What are the seven elements from The Office of Inspector General (OIG) for an effective compliance program, and how can Healthcare Compliance Pros (HCP) help me?
- Implementing written policies, procedures, and standards of conduct: HCP has customized training modules, policies, and procedures for your organization. We also have a huge library of sample policies, procedures, and forms.
- Designating a compliance officer and compliance committee: Once you have designated a compliance committee, HCP can help store your compliance committee meeting minutes.
- Conducting effective training and education. - HCP has many training modules from Compliance, Code of Conduct, HIPAA, OSHA, HR, and many more, all of which are customizable for your organization.
- Developing effective lines of communication. - HCP can also help your organization establish an anonymous hotline.
- Conducting internal monitoring and auditing. - HCP is here to help check your employees and vendors monthly against the OIG Exclusion List and the SAMs List. We can even help run background checks. We also have a HIPAA incident reporting log that can help you determine if it is reportable or not reportable and provide steps in the mitigation process. We also offer a billing and coding audit service through our Compliance Risk Analyzer (CRA).
- Enforcing standards through well-publicized disciplinary guidelines. - HCP can help you develop a disciplinary policy, for we offer many sample templates of policies and procedures.
- Responding promptly to detected offenses and undertaking corrective action. - HCP has several ways to help you track and log compliance and HIPAA issues, along with forms to help you through the process of logging and responding and putting a corrective action plan in place. Plus, we also offer an anonymous hotline for your employees to report compliance issues.
What are the seven elements of an effective compliance program?
1) Written Policies and Procedures
2) Designation of a Compliance Officer and a Compliance Committee
3) Training and education
4) Auditing and monitoring
5) Open lines of communication
6) Response to detected problems and correction
7) Enforcement of disciplinary standards
How do you know what is expected of you?
Standards of Conduct (or Code of Conduct) state the organization's compliance expectations and their operational principles and values.
Is Corporate Compliance Training only required if the organization is contracted with Medicare?
No. As part of participation in any federal payment program, like Tricare or Medicaid, a provider is required to have an effective corporate compliance program. Part of an effective program includes corporate compliance training. Additionally, many payors contract with CMS in some way or another and as a part of that, require all contracted providers to maintain a corporate compliance program as part of their contract, regardless of if the provider contracts with a federal payment program or not. It's a good idea for our clients who think they don't have to have a corporate compliance program in place to check their payor contracts to see exactly what is required of them and if a corporate compliance program with training is a requirement of their payors. The only time that a corporate compliance program is certain to not be required is if the provider only accepts cash-paying patients.
Are there compliance policies and procedures that should be in place if an employee is allowed to work remotely from home?
Healthcare providers are required to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting PHI and ePHI. They may allow employees to work from home as long as they have conducted a risk analysis and implemented appropriate safeguards to ensure the privacy and security of ePHI that will be accessed and transmitted remotely. Employees who work from home must comply with the same security protocols as employees who work onsite within the facility. They also still need to complete training on the organization's HIPAA Privacy and HIPAA Security policies and procedures.
Are there penalties for not training employees on Fraud, Waste, and Abuse (FWA) laws?
Yes. Laws and regulations exist that prohibit FWA. CMS and the OIG have stated that organizations must create and implement effective training and education on these laws and have policies and procedures in place to maintain compliance. Penalties for violating these laws may include but are not limited to civil monetary penalties, civil prosecution, criminal conviction, fines, exclusion from all federal healthcare program participation, imprisonment, and loss of professional license.
False Claims. What are the consequences of violating the False Claims Act?
Knowingly submitting false or fraudulent claims to Medicare and Medicaid is illegal. You may receive fines of up to 3x the program's loss plus $11,000.00 per claim filed for filing false or misleading claims.
What penalties can you face for violating any of the laws or regulations of fraud, waste, and abuse?
Penalties for violating these laws may include but are not limited to Civil Monetary Penalties, Civil prosecution, Criminal conviction/fines, Exclusion from participation in ALL Federal Healthcare programs, Imprisonment, and even Loss of provider license.
What sets Fraud apart from Waste and Abuse? And what are the consequences of Fraud?
Fraud requires the person to have the intent to obtain payment and know that their actions are wrong. Waste and Abuse may involve obtaining an improper payment but do not require the same intent and knowledge. Fraud, being the more severe of the 3, has a devastating impact on not only the practice but the victims. Criminal penalties for submitting fraudulent claims include imprisonment and criminal fines. No one is safe from these repercussions. Even physicians have gone to prison for submitting false claims.
How serious is information blocking?
What are the penalties for blocking information? The 21st Century Cures Act empowers the HHS Office of Inspector General (OIG) to issue civil monetary penalties of up to $1 Million against software developers, networks, or exchanges that interfere with the proper exchange of ePHI. To put it simply, blocking health information is illegal.
How has the pandemic made fraud prevention more difficult?
Due to the increase in Remote working, this new work environment has made it more difficult to prevent fraud within organizations. With the new hurdles, a rise in security and fraud risk has become the new challenge. What is the main reason for this rise in fraud? More than a third of organizations are claiming to not have suitable fraud prevention and response plans established and in place.
What are the most common types of fraud the governments are seeing this year?
Kickback Schemes, Medically Unnecessary Services, Failure to properly charge Medicare/Medicaid patients for prescriptions, Allowing Nurses and Staff to Perform Examinations (essentially any staff members performing outside of their job duties/knowledge/training), and Upcoding.
What is the importance of completing compliance training?
When considering the requirement of providing a security awareness and training program, there are many real-life examples from which to learn. For example, recently, an Office for Civil Rights (OCR) investigation of an entity found long-standing non-compliance with HIPAA Rules, including failures to conduct a security risk analysis, provide a training program on security awareness, and implement HIPAA Security Rule policies and procedures. As a result of this investigation, the entity agreed to pay the Office for Civil Rights (OCR) $65,000 and adopt a corrective action plan to settle these violations of the HIPAA Security Rule.
Why is it essential to run my physicians, employees, and vendors through the OIG and SAM Exclusion List?
The Office of Inspector General was established to identify and eliminate fraud, waste, and Abuse in the U.S. Department of Health and Human Services. The Secretary gave authority to the OIG to exclude from participation in Medicare, Medicaid, and other Federal healthcare programs individuals that have engaged in fraud or Abuse, in which they may impose civil money penalties (CMPs) for misconduct related to Federal healthcare programs. Here is a recent example of CMPs set on an eye care provider. This provider had to pay civil monetary penalties of $17,562.24 for employing an individual excluded from participation in the Federal health care programs.
With COVID-19 transmission predicted to go up this fall, what can employers do to be prepared to operate during high-transmission time periods?
Healthcare organizations should follow the CDC's and OSHA's recommendations to prepare for pandemic outbreaks of varying severity levels. Additionally, the CDC recommends encouraging everyday preventative actions for employees such as staying home when you are sick, covering your coughs and sneezes with tissues, washing your hands with soap and water for at least 20 seconds as often as you can, using at least 60% alcohol-based sanitizer if soap and water are not available, and cleaning frequently touched surfaces and objects.
Beyond that, nonpharmaceutical interventions (NPIs) have been recommended by public health officials to prevent the spread of communicable diseases. These additional actions include allowing staff members to telework, flexibility in allowing staff to stay home if they or someone in their house is sick, increasing space between staff at work as much as possible, but at least 3 feet, decreasing the frequency of contact among staff members, thinking about postponing or canceling work events and canceling or postponing non-essential work travel.
Finally, because this is an evolving situation and the CDC is providing new guidance on a regular basis, we recommend keeping up with the news of the COVID-19 outbreak, following the instructions of public health officials, updating any policies to keep in line with new recommendations as they may be announced, and providing accurate and consistent information to employees reflecting the guidelines of OSHA, the CDC, and other governmental agencies that may be providing them.
What are the PPE requirements for administrative and clinical employees concerning COVID-19 exposure, including those clinical employees who perform aerosol-generating procedures (AGP)?
OSHA's guidance refers to the CDC's infection control guidance. Additionally, a healthcare facility must conduct a risk assessment and determine which employees are at risk, what the risk is, and what PPE would be appropriate to provide. Regardless of the risk, standard precautions should be followed. Transmission-based precautions should be implemented when in contact with a suspected COVID-19 patient.
The CDC states that healthcare providers should implement universal use of personal protective equipment for healthcare providers. In areas of substantial or high transmission, all employees should be provided additional PPE based on their job responsibilities.
What portions of the OSHA COVID-19 Healthcare ETS are still in effect?
Should an employer include an employee's name on a sharps injury log?
A sharps injury log is intended to track injuries and the departments, devices, or procedures that are causing them. It's not meant to track injured employees. As such, the sharps injury log does not need to include the employee's name. In fact, OSHA states that including the employee's name jeopardizes their confidentiality. If an employer chooses to keep employee names on their log, they have to remove them if asked to share the report with anyone to keep the employee information on the log confidential. However, the bloodborne exposure incident report completed after an exposure incident should include the employee's information, the situation leading to the incident, etc., and be kept in their employee medical records.
What should clients consider when designating an infection control safety coordinator?
The infection control safety coordinator should be someone who is able to understand and identify infectious disease hazards in the workplace and must be knowledgeable in infection control principles and practices as they apply to the workplace and employee job operations. Additionally, the safety coordinator must have the authority to ensure compliance with all aspects of the organization's infectious disease plan so that they can take prompt corrective measures when hazards are identified.
Employers' designated safety coordinators should implement and monitor the infectious disease plan, but the exact responsibilities of a safety coordinator may vary based on the employer and workplace.
Do OSHA regulations and standards apply to the home office?
The Department of Labor's Occupational Safety and Health Administration (OSHA) does not have any regulations regarding telework in home offices. The agency issued a directive in February 2000 stating that the agency will not conduct inspections of employees' home offices, will not hold employers liable for employees' home offices, and does not expect employers to inspect the home offices of their employees. If OSHA receives a complaint about a home office, the complainant will be advised of OSHA's policy. If an employee makes a specific request, OSHA may informally let employers know of complaints about home office conditions but will not follow up with the employer or employee.
Employers who are required to keep records of work-related injuries and illnesses will continue to be responsible for keeping such records for injuries and illnesses occurring in a home office.
Are employers required to have all employees vaccinated against Hepatitis B?
No, employers are required to offer the Hepatitis B vaccine when the employee starts work to comply with OSHA's Bloodborne Pathogens Standard 29 CFR 1910.1030. Employees can decline the Hepatitis B vaccine and would need to sign a declination form. HCP has a form called "Certification of Hepatitis B Vaccination and Declination Form" that can be used for documentation.
When must employers offer employees the Hepatitis B vaccine?
OSHA's Bloodborne Pathogens Standard 29 CFR 1910.1030 states the Hepatitis B vaccine must be offered after training and within ten days of the employee being assigned a job where there is occupational exposure unless the worker has already received the vaccine series previously.