Digital Health & Technology

Expert Analysis

• 3 Practice Tips For Patenting Medical Devices In A Digital Age

  

  In light of a recent surge in digital therapeutic applications that help manage or treat diseases, there are several best practices to follow when patenting medical devices and software, including improving upon existing technology and making the claims as specific as possible, say attorneys at Crowell & Moring.

• How To Minimize FCA Cyber Fraud Enforcement Risk

  

  As the U.S. Department of Justice’s new Civil Cyber-Fraud Initiative signals a rise in False Claims Act enforcement and whistleblower actions for cybersecurity-related fraud, government contractors and grantees should take five preventative steps to mitigate increased risks, say Brenna Jenny and Sujit Raman at Sidley.

• What Blockchain Means For The Future Of US Health Care

  

  As the U.S. plays catchup with other countries that have introduced blockchain into their health care systems, the technology is poised to drastically change the industry's revenue cycles, data management and beyond, which will result in better care for patients and more assurance for provider reimbursements, say Michael Ruggio and Jacob Butz at Ice Miller.

• How To Navigate California's New Intrastate CBD Route

  

  Businesses and consumers should prepare for rigorous compliance checks on manufacture, distribution and retail sale of consumer products made with CBD and other hemp-derived cannabinoids. following California's new law opening the potentially enormous market for these items, says Christian Foote at Clark Hill.

• Manufacturers Face Evolving COVID-19 Legal Challenges

  

  Product manufacturers must adopt new strategies to defend against pandemic-related legal challenges, including discovery delays in health care litigation, novel consumer protection claims, aggressive government enforcement actions and supply chain disputes, says Stephanie Laws at Maslon.

• FTC's Hasty Health Data Rule Change Could Cause Confusion

  

  The Federal Trade Commission's recent policy statement expanding the scope of its Health Breach Notification Rule appears to bypass appropriate administrative processes and may delay effective privacy and security policies that can advance interoperability and health innovation, says Jodi Daniel at Crowell & Moring.

• 'McMorris Factors' Create Obstacles For Data Breach Plaintiffs

  

  The factors for evaluating standing in the context of data breach allegations set forth by the Second Circuit in McMorris v. Carlos Lopez & Associates earlier this year may be difficult, if not impossible, for plaintiffs to satisfy, but the standard varies from circuit to circuit, say David Topol and Pamela Signorello at Wiley.

• Telehealth Providers Must Beware Of Fraud As Industry Grows

  

  A recent fraud charge against a telehealth executive highlights the rise we're seeing in telefraud scams during the industry's pandemic growth, and there are some steps that all health providers should take to stay clear of potentially illegal arrangements, says LaTawnda Moore at Dinsmore.

• The Regulatory Growing Pains For Digital Health Companies

  

  The meteoric rise of digital health services during the pandemic has been matched with increasing regulatory scrutiny in the U.S. and abroad, resulting in a patchwork of laws and approaches that could leave a damper on the industry's growth, say attorneys at Kobre & Kim.

• Policyholder Best Practices As Cyberattacks Escalate

  

  As ransomware attacks increasingly target corporate victims, policyholders should enhance cybersecurity and privacy efforts to avoid regulatory hot water and mitigate the effects of rising insurance premiums and coverage restrictions, say Lee Epstein and Krishna Jani at Flaster Greenberg.

• Navigating Asia-Pacific Health M&A In The Wake Of COVID

  

  Bernard Lui and Vanessa Ng at Morgan Lewis discuss new legal considerations for participants in health care mergers and acquisitions with entities in Singapore and elsewhere throughout the Asia-Pacific region as the pandemic continues.

• Life Sci Cos. Should Prep For Enforcement After COVID Pause

  

  With the U.S. Food and Drug Administration and other federal agencies beginning to turn their sights back to pre-COVID-19 agendas, now is the time for life sciences companies to proactively address certain key areas that are likely to draw enforcement action, including physician speaker programs and data integrity, say attorneys at Buchanan Ingersoll.

• 4 Considerations In Light Of Cyber Incident Notification Bill

  

  Following the recent introduction of a bipartisan bill that would require government contractors and critical infrastructure operators to report cyber intrusions to the federal government within 24 hours, companies should take several steps to assess their preparedness for identifying vulnerabilities and mitigating the risk of cyberattacks, say attorneys at Squire Patton.