Medical Device Legal News with Sam Bernstein: Episode 11
On August 21, the National Institute of Standards and Technology (NIST) released the second draft of its revised Digital Identity Guidance, which NIST first published in 2004 and last revised in 2017. The draft guidance...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
On July 26, the U.S. Department of Commerce announced new guidance and tools to enhance the safety, security, and trustworthiness of AI systems pursuant to President Biden’s Executive Order on AI (covered by InfoBytes here)....more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
The flurry of AI-related activity has certainly begun. Earlier this week, the Department of Commerce’s National Institute of Standards and Technology (NIST) released new draft guidance to improve the safety, security and...more
The U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI) systems. Two drafts provide guidance to...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more
The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more
Regulators and plaintiffs’ attorneys are increasingly focused on privacy harms related to the collection and use of personal data. Could privacy enhancing technology (PETs) be a solution to these concerns?...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
The Biden Administration’s recent publication of the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and its request for comments on the draft guidance will impact how march-in rights...more
On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
In this month's edition, we examine the European Commission's Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more
The National Institute of Standards and Technology has issue a set of draft principles for “explainable” artificial intelligence and is accepting comments until October 15, 2020. The authors of the draft principles outline...more
NIST’s news draft guidance, Special Publication 800-53B, Control Baselines for Information Systems and Organizations, provides important information on selecting both security and privacy control baselines for the Federal...more
NIST recently released the final public draft of SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information: A Supplement to NIST Special Publication 800-171 (formerly Draft NIST SP...more
On January 7, 2019, the federal Office of Management and Budget (OMB) released a draft of a memorandum setting forth guidance to assist federal agencies in developing regulatory and non-regulatory approaches regarding...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more
The National Institute of Standards and Technology (NIST) announced this week that it has issued draft cybersecurity guidance for hospitals to consider when using infusion pumps, particularly since infusion pumps are no...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more