Digital Health & Technology

Expert Analysis

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

• Considering CGL Defense For Social Media Addiction Claims

  

  A recent lawsuit filed in California state court against Meta seeks damages from technology companies for the costs of treating children allegedly suffering from social media addiction, but the prospects of defense coverage under commercial general liability insurance policies for a potential new wave of claims look promising, say Craig Hirsch and Tae Andrews at Pasich.

• HHS Opioid Rule Generally Benefits Providers And Patients

  

  The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.

• Defense Attys Must Prep For Imminent AI Crime Enforcement

  

  Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

• Direct Claims Ruling May Alter Gov't Ties To Software Firms

  

  A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.

• What To Know About State-Level Health Data Privacy Laws

  

  Companies that handle consumer health data, including those in the retail sector, should take a conservative approach when interpreting the scope of new health privacy laws in Washington, Nevada and Connecticut, which may include development of privacy notices, consent procedures, rights request response processes and processor contracts, say attorneys at Hunton.

• HHS' Updated Tracking Tech Guidance Offers Little Clarity

  

  The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

• Contract Disputes Recap: Facts Differ But Same Rules Apply

  

  Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

• Hospitals Must Adapt To Growing Cybercrime Threats

  

  As the tide of cybersecurity attacks targeting the healthcare industry continues to grow, hospitals and healthcare providers must take steps to protect themselves, including by replacing legacy records systems and ensuring that business associate agreements address responsibility for breaches, says Christine Chasse at Spencer Fane.

• Assessing FDA Pathways For Genome-Edited Plant Foods

  

  The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

• Spartan Arbitration Tactics Against Well-Funded Opponents

  

  Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

• How AI May Be Used In Fintech Fraud — And Fraud Detection

  

  Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.