Digital Health & Technology

Expert Analysis

• HHS Lab Test Rule's Likely Impact During And After COVID-19

  

  The U.S. Department of Health and Human Services' recent announcement rescinding the U.S. Food and Drug Administration's premarket review requirement for laboratory-developed tests upends regulatory expectations for the clinical laboratory industry and raises questions regarding implementation during the pandemic and beyond, say attorneys at Ropes & Gray.

• Compliance Lessons From $1M HHS Fine For Data Breach

  

  The U.S. Department of Health and Human Services recently fined Lifespan Health over $1 million for Health Insurance Portability and Accountability Act breaches, showing that health care companies should take protective compliance measures, such as encrypting devices and utilizing business associate agreements, say attorneys at Spencer Fane.

• Analyzing Upward And Downward Trends In Legal Tech

  

  Advances in legal technology are often accompanied by bombastic overstatements, but it is important to separate the wheat from the chaff by looking at where various technologies stand on the hype curve, says Lance Eliot at Stanford Law School.

• Telehealth Providers Should Beware ADA Litigation

  

  Health providers making the transition to remote care should furnish communication aid and necessary accommodation for individuals with disabilities, or else plaintiffs may assert claims under the Americans with Disabilities Act, say Frank Morris and Shira Blank at Epstein Becker.

• Prepare For DOJ's Pandemic-Related Enforcement Priorities

  

  Although the U.S. Department of Justice recently said False Claims Act enforcement around coronavirus relief funds won't target good faith actions, companies should proactively monitor regulatory changes and ensure compliance documentation because convincing the government of one's honest intentions can be an uphill battle, say attorneys at Akin Gump.

• 5 Compliance Lessons From Novartis' FCPA Settlement

  

  Novartis' parallel settlements with the U.S. Department of Justice and U.S. Securities and Exchange Commission to resolve criminal Foreign Corrupt Practices Act allegations emphasize risk points for life sciences companies, especially for repeat offenders, say attorneys at Paul Hastings.

• How Health Info Interoperability Rule Affects Providers

  

  The Centers for Medicare and Medicaid Services' new rule implementing interoperability requirements of the 21st Century Cures Act creates new compliance challenges for health care providers and will ultimately require investments in information technology, say Elizabeth Hein and Cynthia Haines at Post & Schell.

• COVID-19 Telehealth Boom Demands Better Privacy Practices

  

  With demand for telemedicine skyrocketing during the pandemic, health care providers should not be lulled into complacency regarding data privacy simply because the U.S. Department of Health and Human Services has relaxed its standards, as pre-pandemic practices may be inadequate, says Geoffrey Lottenberg at Berger Singerman.

• What COVID-19 Means For The Future Of Health Mergers

  

  Health industry sectors, including hospitals and physician organizations, are likely to see growth in consolidation activity as a result of COVID-19, but remote deal-making and other challenges will increase the difficulty of finalizing deals, says Larry Gage at Alston & Bird.

• Health Info Interoperability Rule Raises Privacy Concerns

  

  A new Office of the National Coordinator for Health Information Technology rule requires health care providers to supply patients' health information upon request, but compliance may be complicated when patient privacy laws prohibit information sharing, say Elizabeth Hein and Cynthia Haines at Post & Schell.

• Cybersecurity Steps For Law Firms Amid Heightened Risks

  

  With large swaths of the population indoors and primarily online, cybercriminals will be able to exploit law firms more easily now than ever before, but some basic precautions can help, says Joel Wallenstrom at Wickr.

• Consumer Device Data May Pose Problems In Med Mal Suits

  

  Information generated by smart watches and other consumer technology may help doctors assess patient health, but could be subject to challenges during medical malpractice suits since it is still unclear who can legally authenticate it, says Marilyn Skrocki at Saginaw Valley State University.

• Health Cos.' Biz Associate Agreements Need COVID-19 Update

  

  Health providers should update their business associate agreements to account for increased federal enforcement related to COVID-19, rising usage of telehealth and new rules regarding interoperability, say Cynthia Haines and Elizabeth Hein at Post & Schell.