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News Briefs - March Healthcare Data Breaches Declined 46% to Lowest Since 2022 - Healthcare data breaches appear to be on the decline for now. The HIPAA Journal reported just 58 breaches in March -- the lowest total for the...more
Last year saw growing investment in digital health startups addressing women+ health needs—but women still lag behind men when it comes to adopting these new technologies, according to a new report from Rock Health....more
News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more
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
News Briefs - Hospitals Urged to Check for Accuracy as AI Use Increases -About 65 percent, or 1,696, of U.S. hospitals surveyed reported using artificial intelligence or predictive models integrated with their electronic...more
Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more
As we kick off 2025, it's worth reflecting on the forces that shaped digital health in 2024. From early-stage innovation capturing investor attention to mega funds like a16z and General Catalyst driving dealmaking, the year...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin’s Health-e Law Podcast, Deirdre O’Neill, Chief Commercial & Legal Officer at...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
Expansion of AI in Healthcare - At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more
Today, a tale of two markets are seen in healthcare mergers and acquisition (M&A): the present (as reflected in the data about declining dealmaking) and the future (reflected in the increasingly positive outlook by...more
200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
News Briefs - FTC Aims to Take Action on Non-Competes, M&A Enforcement - Healthcare lobbying organizations' efforts to carve out industry-specific exemptions in recently proposed Federal Trade Commission policies are...more
At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be...more
Funding Environment Toughest in 40 Years - The consensus of the four members of a panel on funding and financing healthcare is that the environment is tougher than they experienced in the wake of the 2008 financial crisis....more
Artificial intelligence and healthcare are hardly strangers, as machine learning programs have been aiding in the diagnosis of disease, drug discovery, the streamlining of clinical workflows and the analysis of medical data...more
During this session, CEOs and founders of transformative digital-health companies shared their experiences and offered thoughts on today’s market and where care delivery is heading next...more
During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more
Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more