News & Analysis as of

Food and Drug Administration (FDA) Data-Sharing

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

Holland & Knight LLP

FTC Seeks First-Ever Health Breach Notification Rule Enforcement: Pixel Users Beware

Holland & Knight LLP on

For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more

King & Spalding

GAO Issues Report on Artificial Intelligence in Health Care

King & Spalding on

On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more

Morgan Lewis - Tech & Sourcing

Metaverse Health: A Chance to Respawn Data Interoperability, Privacy, and Security

As we all try to keep up with the Metaverse and as the healthcare system wilts under a data deluge, the convergence of realities in a shared online space is not merely a chance for practitioners and patients to find each...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

McDermott Will & Emery

Modernizing FDA’s Data Strategy: Agency Announces March 27 Public Meeting, Requests Written Comments by End of April

McDermott Will & Emery on

On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Cooley LLP

Blog: New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

Cooley LLP on

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of...more

Knobbe Martens

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

Knobbe Martens on

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more

Troutman Pepper

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Troutman Pepper on

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

Mintz - ML Strategies

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

Mintz - ML Strategies on

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

Bergeson & Campbell, P.C.

EPA and FDA Sign Memorandum of Understanding to Share Data

The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential...more

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