Digital Health & Technology

Expert Analysis

• Compliance Considerations For Pharma Co. Testing Programs

  

  Diagnostic tests sponsored by pharmaceutical companies can provide real benefits to patients, but should be carefully structured to mitigate compliance risks related to possible fraud and patient privacy, say Eve Brunts and Alison Fethke at Ropes & Gray.

• Gov't Authorities Should Assist Ransomware Targets

  

  As more companies make the prudent decision to pay ransoms following cyberattacks — recently demonstrated by Colonial Pipeline's decision to make a multimillion-dollar payment — governments should use these opportunities to identify and punish perpetrators, rather than simply admonishing victims, say attorneys at Clifford Chance.

• Bracing For The Next Wave Of Health Care Enforcement

  

  Health companies should take proactive steps against a coming wave of federal enforcement, in light of massive new health funding, agencies' desire to protect COVID-19 relief funds, increased use of data analytics and a likely rise in qui tam suits, say attorneys at Foley & Lardner.

• Indoor Air Pollution Fix Will Require New Laws, New Tech

  

  The COVID-19 pandemic, an aging population and changing workplace dynamics all foretell more exposure to indoor air pollutants, so a multidisciplinary policy approach combining technology, insurance, funding and regulation will be needed to improve indoor air quality and health, says Ann Al-Bahish at Haynes and Boone.

• How Justices' AMG Ruling Affects Privacy And Cybersecurity

  

  The U.S. Supreme Court's recent ruling in AMG Capital Management v. Federal Trade Commission removes the regulator's ability to seek monetary damages that discouraged privacy and cybersecurity breaches, and as a result, companies should reassess their exposure in these areas, say attorneys at Orrick.

• COVID's Int'l Trade Impact Holds Health Co. Legal Implications

  

  Pandemic-prompted changes to international trade are highlighting novel legal issues related to the health care industry's reliance on an international supply chain, the proliferation of counterfeit supplies, and risks associated with offshoring administrative support, say Brett Johnson and Claudia Stedman at Snell & Wilmer.

• 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.