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In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more
In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more
Federal agencies proposed or finalized several important rulemakings during the third quarter of 2024, raising new opportunities and considerations for government contractors. Below, we highlight some of these changes and...more
In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more
Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care are among the principal current focuses of U.S. Department of Health and Human Services (HHS) and were included in...more
Last week, the White House issued an update on President Biden’s October 30, 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (the “AI EO” or “EO”). The update detailed...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
As companies increasingly integrate AI into their products, services, processes, and decision-making, they need to do so in ways that comply with the different laws that have been passed and proposed to regulate the use of AI...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) on April 11, 2023, released a Notice of Proposed Rule Making called the Health Data,...more