Digital Health Industry Take Note: New HIPAA Comment Opportunity and Guidance Addresses Growing Risk of Cybersecurity Attacks
Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations.
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released a request for information (RFI) … Read More
Using Data De-Identification to Protect Companies
Many companies hope to benefit from amassing large amounts of data by mining it for market insights, creating internal business models, and supporting strategic, data-driven decisions. But as companies collect and store increasingly enormous volumes of data, they may unknowingly take on significant legal risks, including potential violations of data … Read More
HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health … Read More
OCR 2020 Settlements Target HIPAA Security Rule Non-Compliance
In almost the first three quarters of 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) has settled three cases related to alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”), totaling $1,165,000. These settlements underscore OCR’s continued focus on enforcement of the … Read More
SAMHSA Releases Final 42 CFR Part 2 Revised Rule
On July 13, the Department of Health and Human Services’ Substance Abuse and Mental Health Services (“SAMHSA”) announced final revisions to the Confidentiality of Substance Use Disorder Patient Records regulation codified at 42 CFR Part 2 (so-called “Part 2” regulations). These regulations—which apply to certain information relating to patients being … Read More
HHS Issues Limited Waiver of Certain HIPAA Privacy Rule Obligations and Exercises Enforcement Discretion with Respect to Telehealth Services In Light of COVID Public Health Emergency
This week the U.S. Department of Health and Human Services (HHS) took action to waive penalties and refrain from enforcing certain federal health information privacy restrictions under the Health Insurance Portability and Accountability Act (HIPAA) in response to COVID-19.
Part 2 Proposed Rule Seeks to Reduce Barriers to Coordination of Care for Substance Use Disorders
In an effort to reduce barriers to coordination of care, the U.S. Department of Health and Human Services (“HHS”) is considering changes to Federal restrictions on the sharing of substance use disorder (“SUD”) records. The proposed changes would modify 42 C.F.R. Part 2 (“Part 2”) regulations that place restrictive conditions … Read More
OCR Reduces HIPAA Penalties and Clarifies Liability for Transferring ePHI to Third-Party Health Apps
New Annual HIPAA Penalty Tiers
Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) has announced that it is exercising its enforcement discretion to lower maximum annual HIPAA penalties.
First Multistate HIPAA Data Breach Lawsuit May Signal Increased State Interest in Data Security Enforcement
On December 3, 2018, twelve attorneys general (“AGs”) jointly filed a data breach lawsuit against Medical Informatics Engineering and its subsidiary, NoMoreClipboard LLC (collectively “the Company”), an electronic health records company, in federal district court in Indiana. See Indiana v. Med. Informatics Eng’g, Inc., No. 3:18-cv-00969 (N.D. Ind. filed … Read More
HHS Requests Feedback on HIPAA Changes Designed to Improve Care Coordination
On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve Coordinated Care.” The RFI seeks public input on a broad range of potential reforms to Health … Read More