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ONC Healthcare Food and Drug Administration (FDA)

MoFo Life Sciences

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

MoFo Life Sciences on

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 7, November 2024

Welcome to our seventh issue of The Health Record - our healthcare law insights e-newsletter. This will be our final issue of 2024. When we started this publication earlier this year, our goal was to provide our clients,...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Robinson+Cole Data Privacy + Security Insider

ONC and OCR Issue Joint Fact Sheet on Use of PHI for Public Health Activities

Whenever fact sheets or other guidance is issued by either the Office of the National Coordinator for Health Information Technology (ONC) or the Office for Civil Rights (OCR), it helps gain insight into the thinking of the...more

Foley & Lardner LLP

Details Emerge for President’s Precision Medicine Initiative

Foley & Lardner LLP on

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

Mintz - Health Care Viewpoints

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more

McDermott Will & Emery

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

McDermott Will & Emery on

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

Sheppard Mullin Richter & Hampton LLP

Proposed health IT strategy aims to promote innovation

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft...more

Sheppard Mullin Richter & Hampton LLP

House committee questions authority of a DHHS staff division to regulate health IT

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...more

Mintz - Health Care Viewpoints

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

Foley & Lardner LLP

Finally…FDASIA Health IT Regulation Report Released

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

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