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Health Care Providers Software Developers

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

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Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

McDermott Will & Emery

How the Utah Artificial Intelligence Policy Act Impacts Health Professionals

McDermott Will & Emery on

On March 13, 2024, Utah Governor Spencer Cox signed Utah State S.B. 149, the Artificial Intelligence Policy Act (the AI Act) into law, which amends the Utah consumer protection and privacy laws to require disclosure, in...more

Hogan Lovells

JPM2023 Trendspotting: commercializing digital therapeutics

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Clinical Decision Support (CDS) Software Guidance

In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Nutter McClennen & Fish LLP

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

Patrick Malone & Associates P.C. | DC Injury...

Deceptive software pushed MDs to prescribe opioids at overdose crisis’ peak

Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system....more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Sheppard Mullin Richter & Hampton LLP

Medical Devices - Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

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Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q2 2018

Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) - Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more

Jones Day

FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device

Jones Day on

On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an...more

Holland & Knight LLP

Malpractice by a Computerized Decision-Support Tool?

Holland & Knight LLP on

Mrs. Skounakis died of a coronary artery occlusion after being prescribed an unusual combination of drugs (phendimetrazine and liothyronine) by Dr. Sotillo for weight loss. Her husband sued Dr. Sotillo for malpractice. What...more

Akin Gump Strauss Hauer & Feld LLP

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

Holland & Knight LLP

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

Foley & Lardner LLP

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

Foley & Lardner LLP on

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

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