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HHS final rule requires HIPAA compliance changes for reproductive health care information

The HIPAA Privacy Rule has been modified by the US Department of Health and Human Services (HHS) to increase privacy protections for reproductive health care information. These changes, which will take effect in early 2026,...more

Updated OCR guidance does not solve HIPAA’s tracker uncertainty

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance concerning compliance obligations for HIPAA covered entities and business associates using online tracking...more

HHS finalizes Part 2 substance use disorder rules enhancing privacy protections and care integration

The U.S. Department of Health and Human Services (HHS) has finalized amendments to more closely align the Part 2 substance use disorder (SUD) regulations with HIPAA. These changes have the potential to streamline compliance...more

The White House AI Executive Order: reshaping AI use in the health sector

President Biden’s groundbreaking Executive Order on artificial intelligence carries significant implications for the health and life science industry. The Order tasks federal agencies, including those responsible for health...more

The online health data ecosystem takes another regulatory hit

Health companies cannot use online tracking technologies like other consumer organizations. This refrain, repeated frequently by regulators, litigants and the media in recent months, may now have found its clearest voice in...more

Not so fast: HHS OCR warns that HIPAA applies to online tracking technologies

Covered Entities and Business Associates must comply with HIPAA in their use of online tracking technologies, including cookies, pixels or similar code. The U.S. Department of Health and Human Services (HHS), Office for Civil...more

HHS proposes significant changes to Part 2 substance use disorder records regulations

The U.S. Department of Health and Human Services (HHS) has proposed to significantly revise rules governing patient records in substance use disorder (SUD) programs, commonly known as the Part 2 rules, with important...more

HHS highlights significance of new healthcare technologies in series of regulatory actions

Recent U.S. Department of Health Human Services (HHS) regulatory actions emphasize the role emerging technologies play in the provision of healthcare, particularly as clinical innovations proliferate in response to the...more

HHS issues guidance on disclosures of patient reproductive health information

In the wake of the Supreme Court’s seismic decision in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services (HHS) has issued guidance to help patients, providers, and other health...more

HHS seeks comment by June 6 on recognized security practices as mitigating factor in HIPAA enforcement

The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...more

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