Expert Analysis

• Rare FDA Move Shows Stance On Remote Monitoring Devices

  

  The U.S. Food and Drug Administration's recent warning letter to iRhythm Technologies represents a relatively unprecedented degree of scrutiny to the remote monitoring device industry, say attorneys at Sheppard Mullin.

• Tips For In-House Legal Leaders In A Challenging Economy

  

  Amid today's economic and geopolitical uncertainty, in-house legal teams are running lean and facing increased scrutiny and unique issues, but can step up and find innovative ways to manage outcomes and capitalize on good business opportunities, says Tim Parilla at LinkSquares.

• Health Providers Must Beware FCA Risks When Using AI

  

  Though recent innovations in artificial intelligence can potentially bring increased productivity, greater efficiency and reduced costs to the healthcare industry, providers must take appropriate precautions to avoid risks and potential False Claims Act liability, says Sara Lord at Arnall Golden.

• New Considerations In Med Device Cybersecurity Compliance

  

  Recent guidance from the U.S. Food and Drug Administration clarifies premarket submission procedures related to medical device cybersecurity, and indicates a significant expansion in the agency's expectations surrounding risk management practices for both manufacturers and providers, says Meghna Parikh at Buchalter.

• Federal Oversight Of AI In Healthcare Is Taking Shape

  

  A recent proposed rule from the U.S. Department of Health and Human Services provides early insights into how the federal government intends to oversee artificial intelligence and machine learning in healthcare, highlighting priorities like transparency, equity and potential kickback implications, say attorneys at Hooper Lundy.

• A Close Look At Pennsylvania's Data Breach Law Changes

  

  New amendments to Pennsylvania's Breach of Personal Information Notification Act will hold state agencies to stricter notification requirements more in line with those in other states, and will allow entities to determine a breach has occurred before their notification obligations take effect, says Lauren Godfrey at Constangy.

• Abortion Pill Rulings Will Hinder FDA Authority

  

  Although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the U.S. Food and Drug Administration's approval of a commonly used abortion medication, several points made by the courts are worth considering for their potentially chilling effect on FDA authority and the challenges they may create for the life sciences industry, say attorneys at Morgan Lewis.

• Key Guidelines For Conducting Clinical Trials Overseas

  Excerpt from Practical Guidance

  

  Conducting clinical trials outside the U.S. offers many benefits to researchers, but these benefits come with countervailing ethical and legal challenges that must be carefully addressed, say attorneys at Bass Berry.

• Recent Growth Factors Driving Life Sciences Transactions

  

  In view of challenges posed by last year's economic downturn, life sciences companies have increasingly turned to collaboration and licensing arrangements, with a focus on deal activity in artificial intelligence, digital health and gene therapy, say attorneys at Ropes & Gray.

• How Cannabis Cos. Can Keep Up With Privacy Compliance

  

  With the cannabis industry's rapid growth and access to sensitive consumer information, and the ever-changing patchwork of state data privacy laws, it is becoming increasingly important for marijuana businesses to treat cybersecurity as a significant risk and management priority, say attorneys at Goodwin.

• FTC's Health Privacy Actions Offer 5 Advertising Takeaways

  

  The Federal Trade Commission's recent enforcement actions against GoodRx and BetterHelp highlight the need for any company engaging in common online advertising practices to pay close attention to the personal information they collect and share with third parties, say Kate Black and Sam Castic at Hintze Law.

• States Shouldn't Fear HIPAA When Improving Gov't Services

  

  As the looming end of the COVID-19 public health emergency motivates states to streamline their processes for individuals seeking public benefits, they should generally not have to worry about violating the Health Insurance Portability and Accountability Act when sharing data across government services, says Jodi Daniel at Crowell & Moring.

• 5 Data Privacy Practices Cos. Should Implement Now

  

  Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.