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21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

Federal District Court Casts Doubt on HHS HIPAA Tracking Technology Guidance

The U.S. District Court for the Northern District of Texas ruled that HHS's December 1, 2022, guidance applying HIPAA to online tracking technologies is unlawful with respect to its treatment of certain combinations of...more

HHS Amends HIPAA To Further Protect Privacy of Reproductive Health Care Information

The U.S. Department of Health and Human Services (HHS) this week released final amendments to the HIPAA Privacy Rule to further protect the privacy of protected health information (PHI) related to reproductive health care....more

OCR Updates Guidance on HIPAA and Online Tracking, But New Examples Lead to New Questions

Changes to guidance are unlikely to mitigate widespread concerns - On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) revised its controversial guidance on how HIPAA applies...more

LEAP, Don't Run, to Make this YEAR's Deadline: HIPAA Small Breach Notifications Due February 29

February 29, 2024, is the date by which HIPAA-covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of all "small" breaches of unsecured protected health information that...more

HHS Reveals Strategy for Addressing Healthcare Sector Cybersecurity

The U.S. Department of Health and Human Services ("HHS") issued a concept paper describing its overarching strategy to address healthcare cybersecurity. The concept paper builds on the Biden-Harris Administration's National...more

HHS Proposes Information Blocking Disincentives for Health Care Providers

While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more

Is AI Development "Research" Under HIPAA?

Continued advancement in artificial intelligence offers great promise to improve health care. But AI feeds on tremendous amounts of data, and using protected health information (PHI) to develop or improve AI often involves...more

Deadline Approaching for Comments on Proposed Changes to Substance Use Disorder Confidentiality Rule

The Department of Health and Human Services ("HHS") has proposed amendments to the Confidentiality of Substance Use Disorder Patient Records Rule, 42 C.F.R. part 2 (the "Part 2 Rule") with a comment deadline of January 31....more

HHS Publishes Guidance on Using Online Tracking Technologies Under HIPAA

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a bulletin on December 1, 2022, clarifying that "regulated entities are not permitted to use tracking technologies in a manner that would...more

Information Blocking Rule Expands to Cover Electronic Designated Record Set

In two weeks, on October 6, 2022, the scope of the 21st Century Cures Act Information Blocking Rule expands to prohibit health care providers from blocking or interfering with patient access to any electronic information in a...more

OCR Issues New Guidance Applying Security Rule to Digital Voice Transmissions and Storage

On June 13, 2022, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced new guidance on using remote communication technologies to provide audio-only telehealth services in compliance with...more

OCR Requests Comment on Significant HIPAA Enforcement Rulemaking

Just one month remains to comment on the U.S. Department of Health and Human Services (HHS) Office for Civil Rights' (OCR) current Request for Information (RFI), which seeks public input on the implementation of two statutory...more

Politics and PHI, Bad Online Reviews, and the Right of Access

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced four enforcement resolutions at the end of March 2022, with issues ranging from the misuse of protected health information (PHI)...more

Some Things Are Inevitable … Death, Taxes, and Rising HIPAA Penalties

It used to be easy to calculate HIPAA penalties in your head—$50,000 per violation and up to $1.5 million per calendar year for multiple violations of the same HIPAA provision. But those days of easy math are long gone since...more

More Time for Filing Comments on Proposed HIPAA Changes

The U.S. Department of Health and Human Services (HHS) recently announced a 45-day extension of the comment period for proposed changes to the HIPAA Privacy Rule. The deadline for submitting comments now has been pushed from...more

Will the Biden Administration Complete the "Regulatory Sprint" With HHS' Proposed HIPAA Amendments?

On January 21, 2021, the Department of Health and Human Services (HHS) published proposed changes to the privacy rule (Privacy Rule) of the Health Insurance Portability and Accountability Act (HIPAA). This Notice of Proposed...more

HIPAA May Apply to Employer COVID-19 Testing Programs

When COVID-19 first began to spread in the United States, a recurring question we received was whether employers become subject to HIPAA by taking employee temperatures or collecting medical information. The answer generally...more

Top HHS "Information Blocking" Regulatory Compliance Challenges

As the November 2 compliance date quickly approaches, healthcare providers are finding that tackling the new "information blocking" regulations from the U.S. Department of Health and Human Services requires substantial...more

What the ONC and CMS Final Rules For Interoperability Mean for Data Exchange and Patient Access to Health Information

While the healthcare industry is under siege battling COVID-19, on March 9, 2020, the U.S. Department of Health and Human Services (HHS) moved ahead and finalized two long-awaited and controversial rules related to...more

More Data Please! The Challenges of Applying Health Information Privacy Laws to the Development of Artificial Intelligence

Artificial intelligence (AI) has become part of our daily lives, from greeting us in the morning through smart home devices, creating shopping lists, playing music, setting timers, and alerting us of a traffic jam on our...more

HHS Reinterprets (and Significantly Lowers) Annual Penalty Caps for HIPAA Violations

The Department of Health and Human Services Office for Civil Rights (OCR) today announced that it is lowering the maximum total penalties it may assess against covered entities and business associates for multiple violations...more

Where Is the HIPAA Right to Defend One’s Self?

When a patient publicly disparages a health care provider, HIPAA leaves the health care provider in a seemingly impossible situation. If the health care provider does not respond and dispute the allegation, then its...more

Is OCR Moving the Goal Posts on Vendor Management?

Recent statements at the 27th National HIPAA Summit suggest that the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) may be changing its position and expecting a greater level of vendor due...more

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