HHS Proposed Rule Aligns Regulation on Confidentiality of Substance Use Disorder Treatment Records with HIPAA

by Kathie McDonald-McClure

UPDATE: On February 16, 2024, HHS published a Final Rule (89 Fed Reg 12472) to amend Part 2 rules on patient confidentiality of SUD records. While the Final Rule’s effective date is April 16, 2024, the deadline for compliance is February 16, 2026. Based on public comments to the Proposed Rule, HHS included further substantive modifications in the Final Rule, which HHS outlines in a Fact Sheet on the Part 2 Final Rule.

On November 28, 2022, the Secretary for the United States Department of Health & Human Services (HHS) released a Proposed Rule to amend the requirements in Title 42, Part 2, on confidentiality of substance use disorder (SUD) patient records in federally assisted Part 2 Programs.  Part 2 protects the confidentiality of SUD patient records (which generally include alcoholism, alcohol abuse, and drug abuse treatment and prevention records) by restricting the circumstances under which Part 2 Programs or other lawful holders can disclose such records.

Continue reading

OCR Issues Guidance on HIPAA, COVID-19 Vaccination and the Workplace

By: Margaret Young Levi

On September 30, 2021, the Office for Civil Rights (OCR) issued welcome guidance concerning when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies to disclosures and requests for information about whether a person has received a COVID-19 vaccine—and when it does not apply.

The guidance aims to clear up misperceptions about who can ask questions about vaccination. In general, OCR reminds that HIPAA only applies to HIPAA covered entities, such as health care providers (physicians, hospitals, etc.) and health plans, and it does not apply to employers or employment records. The guidance addresses common workplace situations, provides helpful examples, and answers frequently asked questions for HIPAA covered entities, businesses, and the public.

HIPAA does not prohibit businesses, individuals, or HIPAA covered entities from asking whether their customers or clients have received a COVID-19 vaccine. HIPAA does not prohibit any person, whether an individual or a business or a HIPAA covered entity, from asking individuals whether they have received a COVID-19 vaccine. First, OCR makes it clear that HIPAA only applies to HIPAA covered entities, and it does not apply to other individuals or entities. Second, even though HIPAA regulates how and when HIPAA covered entities may use or share information about COVID-19 vaccinations, it does not limit the ability of covered entities to ask patients or visitors whether they have been vaccinated.

The guidance clarifies that HIPAA does not apply when an individual:

  • Is asked about their vaccination status by a school, employer, store, restaurant, entertainment venue, or another individual.
  • Asks another individual, their doctor, or a service provider whether they are vaccinated.
  • Asks a company, such as a home health agency, whether its workforce members are vaccinated.
Continue reading

HITECH Act Amendment: Using “Recognized Security Practices” May Lead to More Favorable HHS Review and Reduced Fines After Data Breach

by Margaret Young Levi and Kathie McDonald-McClure

Congress amended the Health Information Technology for Economic and Clinical Health Act (HITECH Act) on January 5, 2021.  This Amendment requires the U.S. Department of Health and Human Services (HHS) to favorably consider whether covered entities and business associates have implemented specific security measures when making decisions regarding penalties and audits under the Health Insurance Portability and Accountability Act (HIPAA). 

Specifically, the Amendment mandates HHS to “consider whether the covered entity or business associate has adequately demonstrated that it had, for not less than the previous 12 months, recognized security practices in place” when HHS is making decisions to (1) decrease fines, (2) decrease the length and extent of an audit or terminate an audit, and (3) mitigate other remedies with respect to resolving potential violations of the HIPAA Security Rule. 

Continue reading

Audio-Video Conferencing Risks and Tips for Healthcare Providers

by Margaret Young Levi and Kathie McDonald-McClure

Federal and state governments have relaxed restrictions on telehealth to encourage and empower medical providers to serve patients at home during the novel coronavirus (COVID-19) national public health emergency (PHE). Both medical providers and patients have embraced this new way of connecting due to its convenience and, as a result, the expanded use of telehealth is likely here to stay.  The use of audio and video conferencing for patient care, while convenient, risks an unauthorized disclosure of sensitive information if it is used without due regard for whether the connections are secure. 

Following expansion by the U.S. Department of Human Health Services’ Office for Civil Rights (OCR) and the Centers for Medicare and Medicaid Services (CMS) of federal telehealth services and relaxation of certain requirements during the COVID-19 PHE, Kentucky Medicaid followed suit.  See our previous post about Kentucky Medicaid’s expansion of coverage for telehealth. 

OCR Relaxes HIPAA enforcement for telehealth during COVID-19 PHE.  OCR, the agency responsible for enforcement of HIPAA, issued guidance on its enforcement discretion with regard to certain telehealth practices under HIPAA.  This guidance makes it clear that OCR will not enforce penalties for the use of technology that is not HIPAA compliant, when used in the good faith provision of telehealth services.

Under this Notice, covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 PHE. 

Continue reading

Kentucky Medicaid Further Expands Telehealth Coverage

By Lindsay K. Scott

Following expansion by the Department of Human Health Services’ Office for Civil Rights (“OCR”) and the Centers for Medicare and Medicaid Services (“CMS”) of federal telehealth services and relaxation of certain requirements, Kentucky Medicaid is following suit.

On March 17, 2020, the Centers for Medicare and Medicaid Services published guidance expanding the use of telehealth and relaxing restrictions on its use. The Office for Civil Rights, the agency responsible for enforcement of HIPAA, followed up with guidance making it clear that it will not enforce penalties for the use of technology that is not HIPAA compliant, when used in the good faith provision of telehealth services:

Under this Notice, covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency.  Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications.

Continue reading