Digital Health & Technology

Expert Analysis

• Mapping The Predicate Chain For Medical Device Approval

  

  Omar Robles at Emerging Health analyzes the potential magnitude of predicate chains created by the 510(k) pathway for medical device approval, in light of common criticism that the approval process can create chains of devices that reach the marketplace without recent clinical testing.

• Where Health Care Enforcement Is Headed Under Biden

  

  Early actions by President Joe Biden's administration signal a robust health care enforcement environment in which federal agencies will aggressively scrutinize pandemic-related and Medicare Advantage fraud, nursing homes, and medical technology, and False Claims Act activity will likely increase, say attorneys at Alston & Bird.

• Mitigating Anti-Kickback Risks Of Health Tech Stock Warrants

  

  While stock warrants are a practical way for the health technology industry to finance growth, companies should utilize statutory safe harbors to mitigate federal Anti-Kickback Statute compliance risks, which could arise from an improperly structured arrangement that encourages referral of business to a vendor, say Meenakshi Datta and Jon Zucker at Sidley.

• ABA Remote Work Guide Raises Bar For Atty Tech Know-How

  

  A recent American Bar Association opinion on lawyers' ethical duties of competence and confidentiality when working remotely should be viewed as part of a larger movement by which attorneys are being exhorted to develop competence in 21st century technology, say Jennifer Goldsmith at Ironshore and Barry Temkin at Mound Cotton.

• 3 Cybersecurity Questions To Ask Before A Remote Mediation

  

  Lawyers preparing to mediate or arbitrate a case through videoconference should take steps to ensure they and their alternative dispute resolution providers are employing reasonable security precautions to protect digital client data and conform to confidentiality obligations, say F. Keith Brown and Michael Koss at ADR Systems.

• Expect Aggressive Health Care Scrutiny From Mass. US Atty

  

  As we await a new presidentially appointed U.S. attorney for Massachusetts, health business leaders and in-house counsel should reexamine their compliance structures, as the office will likely continue to prioritize enforcement efforts against both traditional areas of focus and pandemic-related fraud, say Jack Pirozzolo and Doreen Rachal at Sidley.

• 4 Areas Of Cyberattack Vulnerability For Law Firms

  

  Recent data breaches involving Goodwin and Jones Day show that cyberattacks are very real threats to the legal profession, especially in the era of remote work, so law firms should revisit common business practices that expose them to unnecessary risks, says Ara Aslanian at Inverselogic.

• 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.