Expert Analysis

• Addressing Legal Issues Raised By AI Use In Health Care

  Excerpt from Practical Guidance

  

  With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.

• New Health Data Compliance Considerations For Pa. Lawyers

  

  Given the regularity with which attorneys handle private health information, it is important for Pennsylvania firms to understand recent significant amendments to the state's data breach law, which address information not currently covered by federal law, says Mark Mattioli at Post & Schell.

• Mitigating Risks Of Developing Drugs And Devices With AI

  

  As the use of artificial intelligence in drug and medical device development advances, companies should implement five key steps to identify and mitigate areas of potential risk before regulatory frameworks catch up, say attorneys at King & Spalding.

• Scope Of FTC's Health Info Enforcement May Expand

  

  The Federal Trade Commission's proposed amendments to the Health Breach Notification Rule signal the agency's mounting efforts to regulate consumer health information beyond the reaches of the Health Information Portability and Accountability Act, which does not cover many recent health apps and technologies, say Jodi Daniel and Brandon Ge at Crowell & Moring.

• How Attys Can Avoid Exposing Their Firms To Cyberattacks

  

  Attorneys are the weakest link in their firms' cyberdefenses because hackers often exploit the gap between individuals’ work and personal cybersecurity habits, but there are some steps lawyers can take to reduce the risks they create for their employers, say Mark Hurley and Carmine Cicalese at Digital Privacy & Protection.

• 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.