Digital Health & Technology

Expert Analysis

• Health Info Blocking Rule Creates Opportunities For Research

  

  The U.S. Department of Health and Human Services' information blocking rule taking effect in April will provide researchers with a new tool for obtaining electronic health information, which could lead to a proliferation of new endeavors and insights, say attorneys at Ropes & Gray.

• 7 False Claims Act Enforcement Trends To Watch

  

  False Claims Act enforcement statistics, along with anticipated enforcement priorities under the Biden administration, suggest that we will see a significant increase in FCA investigations and related litigation, targeting a widening array of industries and categories of defendants, say attorneys at Winston & Strawn.

• Data Compliance Issues For Cos. Making, Using Vaccine Apps

  

  To manage privacy concerns with COVID-19 vaccine verification tools, developers should look to the Federal Trade Commission's Fair Information Practice Principles to build secure applications consistent with U.S. privacy laws, and employers should ensure that notice, recordkeeping and retention requirements are in place, say attorneys at Troutman Pepper.

• A Look At Factors Influencing Medical Device Approval Speed

  

  Analysis indicates that several factors affect U.S. Food and Drug Administration medical device approval times, and that FDA mechanisms for speeding up the process are not especially effective, say analysts at Emerging Health.

• Prepare For NY Data Privacy Law To Catch Up To Calif.

  

  The proposed New York Data Accountability and Transparency Act, along with last year's SHIELD Act, means that the state may soon have comprehensive privacy laws that rival California's, and all businesses with New York customers should take several important compliance steps to prepare, say attorneys at Gibson Dunn.

• Predictions For How Telehealth Law Will Evolve In 2021

  

  Following the significant activity COVID-19 brought to telemedicine and digital health policy in 2020, legislators will likely continue reducing barriers to virtual care this year, but regulators' enforcement efforts will rise as well, says Nathaniel Lacktman at Foley & Lardner.

• Lessons From 2020 Life Sciences Securities Class Actions

  

  Life sciences companies can draw important insights from the many dismissal opinions that federal courts issued during 2020 in securities actions arising from adverse U.S. Food and Drug Administration actions and clinical development setbacks, say Yvonne Puig and Peter Stokes at Norton Rose.

• State AGs' 2020 Actions Offer Hints At 2021 Priorities

  

  A review of state attorney general actions in 2020 addressing consumer concerns including data privacy, product safety and marketplace competition can help companies prepare for the expected regulatory enforcement wave in 2021, say attorneys at Troutman Pepper.

• A Law Of The Digital Sea Could Expand Data Rights, Oversight

  

  Democracies should implement a law of the digital sea that can balance innovation with individual rights and national security by mandating personal ownership of data, rigorously enforcing antitrust law, and empowering agencies like the Consumer Financial Protection Bureau to grade cyberhygiene, says Luke Schleusener at QOMPLX.

• How 2020 Changed Product Liability — And What's Next

  

  Like many other legal sectors, product liability regulation and litigation felt the sharp impact of COVID-19 in 2020, especially in health care and life sciences — and 2021 may hold more pandemic-related changes, as well as a new regulatory approach from the Biden administration, say attorneys at MoFo.

• Gov't Pandemic Response Will Boost Life Sciences In 2021

  

  The U.S. government's response to the COVID-19 pandemic has shown increasing openness to collaborating with life sciences and health companies, leading to advancements in telemedicine and the use of virtual environments that will likely continue through 2021 and beyond, say attorneys at Hogan Lovells.

• FCA Whistleblowers Are More Important Than Ever Before

  

  Though a recent Law360 guest article argued that the new U.S. Department of Health and Human Services' False Claims Act working group is correctly deemphasizing the role of whistleblowers, the group does not actually favor defense counsel and whistleblowers are crucial now due to the surge in emergency funding caused by the pandemic, says attorney Neil Getnick.

• 2020 ERISA Litigation Trends Hint At What's Ahead This Year

  

  Trends from a record-setting year for Employee Retirement Income Security Act litigation show no signs of slowing down in 2021, with more excessive fee claims targeting smaller plans, health coverage continuation notice lawsuits, and challenges to defined benefit plans’ actuarial assumptions likely on the horizon, say attorneys at Groom Law.