Digital Health & Technology

Expert Analysis

• Digging Into The Debate On FDA's Proposed Lab Test Rule

  

  A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

• AI Executive Order's Life Science, Healthcare Industry Effects

  

  The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

• 5 Most Notable Class Action Standing Cases Of 2023

  

  Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.

• How SEC And NY Cyber Reporting Rules Affect Key Industries

  

  The new U.S. Securities and Exchange Commission and New York State Department of Financial Services cybersecurity disclosure requirements, and their competing obligations, reveal the increasing complexity for organizations evaluating and reacting to cybersecurity incidents — particularly those in the healthcare and financial services industries, say attorneys at Manatt.

• In The World Of Legal Ethics, 10 Trends To Note From 2023

  

  Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

• 5 Steps For Healthcare Companies After Biden's AI Order

  

  Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

• The Basics Of Law Firm Cyber Liability Insurance Applications

  

  Cyber liability insurance has become a common consideration for law firms as cyber threats have escalated, but these insurance forms can be quite complicated given the nature of the industry and associated risks, so simply filling out the form won't necessarily result in an ideal policy for your firm, says Kevin Haight at WAMS.

• AI Brings New Insurance Concerns For Healthcare Providers

  

  As the healthcare industry increasingly invests in medical artificial intelligence tools, it confronts a variety of liability risks that necessitate careful consideration and potential recalibration of providers' insurance programs, say Marialuisa Gallozzi and Megan Mumford Myers at Covington.

• Writing Thriller Novels Makes Me A Better Lawyer

  

  Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

• White House Activity Is A Band-Aid For Regulating AI In Health

  

  In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

• How Legal Teams Can Prep For Life Sciences' Tech Revolution

  

  The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

• General Counsel Need Data Literacy To Keep Up With AI

  

  With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

• Life Sciences Regulators Must Write Cloud-Specific Guidance

  

  As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.