News & Analysis as of

Risk Management Digital Health

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Benesch

Dental/DSO Intelligence Monthly Report: January 2025

Benesch on

Moving into 2025, the dental industry faces a series of transformative shifts driven by evolving patient expectations, the rise of Dental Support Organizations (DSOs) and persistent operational challenges. The industry will...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Hogan Lovells

FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI

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Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more

Fenwick & West LLP

Key Takeaways from Digital Health Counsel 2024 AI Summit

Fenwick & West LLP on

Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...more

Foley & Lardner LLP

Technology Trends in Manufacturing and Associated Legal Risk Management: Driving Technological Advancement with an Ecosystem View 

Foley & Lardner LLP on

The importance of building technology-driven manufacturing businesses with an ecosystem focus—i.e., a comprehensive view of the complex network of suppliers, partners, and customers in a market—emerged as a critical theme for...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #3

News Briefs - Joint Employer Rule Withdrawn by National Labor Relations Board - The National Labor Relations Board withdrew its appeal of a district court ruling that enjoined its "joint employer" final rule....more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

McDermott Will & Emery

[Webinar] AI Risk Management 101 - June 29th, 12:00 pm - 1:00 pm ET

McDermott Will & Emery on

Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

NAVEX

What Risk Managers Can Learn From the Health Care Industry

NAVEX on

The COVID-19 pandemic had the silver lining of accelerating the digital transformation of countless industries, and as the dust settles over health care’s own evolution, risk managers will need to navigate an ever-more...more

McDermott Will & Emery

[Webinar] Digital Health Venture Series, Part 2: Preparing Your Start-Up for the Funding Process - December 15th, 1:00 pm - 2:00...

McDermott Will & Emery on

The unique business opportunities created by digital health companies can carry heightened regulatory risks. As investors increase their focus on the digital health sector and as digital health companies engage in more...more

McDermott Will & Emery

[Webinar] Digital Health Venture Series, Part 1: What to Look For When Investing in Digital Health - December 8th, 1:00 pm - 2:00...

McDermott Will & Emery on

The unique business opportunities created by digital health companies can carry heightened regulatory risks. As investors increase their focus on the digital health sector and as digital health companies engage in more...more

Foley & Lardner LLP

Payvider: The Blurring of the Lines Between Payer and Provider in Digital Health Deals

Foley & Lardner LLP on

Hosted by the Health Plan Alliance, I was joined by Ken Barrette, Managing Director of Health Care at Alvarez and Marsal, and Marshall Votta, Operating Partner at Nautic Partners, to discuss the unique opportunities that...more

McDermott Will & Emery

[Webinar] Telemedicine Update: Professional Insurance - April 22nd, 1:00 pm - 2:00 pm EDT

McDermott Will & Emery on

Telemedicine guidance continues at a rapid pace at both the federal and state levels. To keep you in the know, our Digital Health team has joined forces with Larry W. Hansard of Arthur J. Gallagher Risk Management Services,...more

McDermott Will & Emery

Collaborative Transformation - Focus on Innovation Centers - Key Considerations for Investments in Entities Developing Innovative...

McDermott Will & Emery on

Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug...more

Hogan Lovells

French legal and regulatory update - July/August 2019

Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more

Hogan Lovells

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

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