OFFICE FOR CIVIL RIGHTS (OCR)

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The U.S. Department of Health and Human Services (HHS) has announced a new general policy on what factors the agency will take into account when considering whether to make a criminal referral to the Department of Justice (DOJ) for individuals and entities who violate HHS regulations.

The notice, published on June 24, is in response to Executive Order 14294, which was issued by President Trump on May 9, 2025 and is designed to fight “overcriminalization in federal regulations.” That executive order pointed to the Code of Federal Regulations and its reams of pages in which lurk regulations that could result in criminal liability.

Under the executive order, agencies were required to issue guidance in the Federal Register (so, more pages to read) to identify their plan to address criminal regulatory offenses. In addition to this policy guidance, the agencies are required to submit a report within a year to the Office of Management and Budget (OMB) detailing all potentially criminal regulatory offenses as well as the potential punishment for violation of those regulations.Continue Reading HHS Announces Policy on Criminal Referrals for Regulatory Violations

Health care and health care-adjacent organizations are seeing a steep increase in risk arising from the frequently utilized third-party analytics and advertising services on their websites, mobile applications, patient portals, and other Internet-connected services. Those organizations should pay attention to new regulatory guidance, published settlements with regulators, and an onslaught of class action filings stemming…

Starting in 2019, the Department of Health and Human Services Office for Civil Rights (“OCR”) has taken an increased interest in protecting patients’ right of access to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act (“HIPAA”). Over the past twenty months, OCR has announced nineteen settlements under its Right of Access…

Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1]  In the past year…

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient).
Continue Reading Patient access to health information at the forefront of government initiatives and scrutiny