Expert Analysis

• Navigating Decentralized Clinical Trials With FDA's Guidance

  

  The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

• What To Expect Next From Federal Health Tech Regulation

  

  Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

• Defending AI, Machine Learning Patents In Life Sciences

  

  Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.

• Takeaways From Texas AG's Novel AI Health Settlement

  

  The Texas attorney general's recent action against a health tech company marks another step in rapidly proliferating enforcement against artificial intelligence and privacy issues across multiple states, and highlights important risk mitigation considerations for health companies that implement AI systems, say attorneys at Troutman Pepper.

• Proposed Legislation May Crack Down On Online Drug Ads

  

  A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.

• Navigating Restrictions Following Biotech Bill House Passage

  

  Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.

• What's In Colorado's 1st-Of-Its-Kind Neural Privacy Law

  

  Colorado recently became the first U.S. state to directly regulate neurotechnology with new legislation amending the Colorado Privacy Act to specifically protect biological and neural data, offering an example of how lawmakers can tackle the perceived regulation gaps in this area, say attorneys at Goodwin.

• Assessing Algorithmic Versus Generative AI Pricing Tools

  

  A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.

• What FCA Cases May Look Like In The Age Of Generative AI

  

  Generative artificial intelligence raises unique considerations both in the context of potentially leading to False Claims Act cases and in the discovery and litigation phases of these lawsuits, says attorney Rachel Rose.

• The Regulatory Headwinds Facing Lab-Developed Tests

  

  Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

• How Cos. With Chinese Suppliers Should Prep For Biotech Bill

  

  A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

• The Road Ahead For Regulation Of Digital Twins In Healthcare

  

  Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

• After Chevron: Slowing Down AI In Medical Research

  

  The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.