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Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know
June 27, 2024 | Blog | By Pat Ouellette
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 generated plenty of cross-industry interest, for good reason. In some ways similar to the risk-based approach taken by the European Union (EU) in the EU AI Act, the Act aims to regulate developers and deployers of AI Systems, which are defined by the Act as “any machine-based system that, for any explicit or implicit objective, infers from the inputs the system receives how to generate outputs, including content, decisions, predictions, or recommendations, that can influence physical or virtual environments.”
ACA Section 1557 Final Rule: OCR Prohibits Discrimination Related to Use of Artificial Intelligence in Health Care
April 29, 2024 | Blog | By Pat Ouellette
Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care is among the principal current focuses of U.S. Department of Health and Human Services (HHS) and was among the health care directives in the recent Biden Administration Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order). Consistent with these priorities, on April 26, 2024, the HHS Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) released an unpublished version of a new final rule under Section 1557 of the Affordable Care Act (ACA) that aims to broadly address inequity across health care but also requires certain actions of entities covered under Section 1557 around their use of AI in clinical decision-making (Final Rule).
FDA Needs a New Approach to AI/ML-Enabled Medical Devices
March 12, 2024 | Blog | By Benjamin Zegarelli
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the Digital Health Center of Excellence, implementing predetermined change control plans, and issuing various digital health guidances on device software functions, clinical decision support software, cybersecurity, and other topics. In anticipation of FDA’s Artificial Intelligence /Machine Learning (AI/ML) Medical Devices Workshop in October 2021, we posted a brief history of the agency’s regulatory oversight of software through the traditional medical device regulatory framework established in the 1970s, in which we highlighted the numerous challenges associated with such an approach. But now, with the rise of artificial intelligence and machine learning and the proliferation of AI/ML-enabled software throughout the health care industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices. It is becoming increasingly clear that innovation in the AI/ML and digital health technology space is advancing rapidly, as FDA Commissioner Rob Califf has emphasized in many recent public appearances, and that the traditional device framework is quickly becoming unworkable for such technologies.
Health Care Privacy and Security in 2024: Six Critical Topics to Watch
January 25, 2024 | Blog | By Dianne Bourque, Madison Castle, Lara Compton, Ellen Janos, Pat Ouellette, Cassandra Paolillo
As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the regulatory environment with modern health care delivery, cutting-edge technologies, and innovative data-sharing techniques. Some of this work has been done in the form of federal agency guidance in which health care organizations will be looking for additional updates and there are also a handful of pending U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) proposals that call for substantial changes to the HIPAA Privacy Rule.
HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT
January 8, 2024 | Blog | By Pat Ouellette
The Department of Health and Human Services (HHS) was tasked with formalizing and coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI EO) and has already begun its regulation of AI within certain certified health IT. HHS and Office of the National Coordinator for Health Information Technology (ONC) recently published the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
Biden Executive Order Calls for HHS to Establish Health Care-Specific Artificial Intelligence Programs and Policies
November 2, 2023 | Blog | By Pat Ouellette, Lara Compton, Madison Castle
On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House priorities and policies related to the use and development of artificial intelligence (AI) across different sectors, including health care.
The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?
March 14, 2023 | Blog | By Benjamin Zegarelli, Daniel Herling
The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming integration into multiple Internet search engines. This development creates exciting opportunities and potentially terrifying risks in the health care space. Inevitably, people will ask AI chatbot-enabled search engines for information on diseases, conditions, medicines, or medical devices and use the response in some way to make certain medical decisions. But what happens when the AI chatbot’s response is inaccurate or even provides advice that may lead to harm if the user follows it? Can AI chatbots be regulated by the U.S. Food and Drug Administration (FDA)? What are the liability implications if a user is harmed? We provide some initial thoughts on such legal issues in this post.
Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions
October 20, 2021 | Blog | By Lara Compton, Benjamin Zegarelli
Coverage of FDA’s AI/ML Medical Devices Workshop - Part 2: FDA’s Recent Digital Health Initiatives
October 12, 2021 | Blog | By Benjamin Zegarelli, Lara Compton
Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation
October 4, 2021 | Blog | By Benjamin Zegarelli, Lara Compton
Artificial Intelligence in Health Care
February 5, 2020 | Blog
Software Update: The Latest on FDA’s Pre-Cert Pilot
July 22, 2019 | Blog
Strategies to Unlock AI’s Potential in Healthcare Part 6: Commercialization of AI Tools in Healthcare – the Challenge of Securing Adequate Data Rights
November 26, 2018 | Blog | By Julie Korostoff
Strategies to Unlock AI’s Potential in Health Care, Part 5: Product Liability Prevention for AI Product Designers—and Their Lawyers
November 13, 2018 | Blog
Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?
November 2, 2018 | Blog
Strategies to Unlock AI's Potential in Health Care, Part 3: HIPAA and Other Privacy Considerations
October 25, 2018 | Blog | By Dianne Bourque
Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation
October 18, 2018 | Blog
Strategies to Unlock AI’s Potential in Health Care, a Mintz Series
October 12, 2018 | Blog | By Ellen Janos
Strategies to Unlock AI’s Potential in Health Care, Part 1: Common Pitfalls to Avoid When Getting a Patent
October 12, 2018 | Blog | By Christina Sperry
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