Expert Analysis

• The State Of FDA Regulation Of Software As A Medical Device

  

  Though the U.S. Food and Drug Administration has accelerated activities related to software as a medical device, developers should carefully consider guidance gaps and challenges regarding transparency and change management in software that utilizes artificial intelligence and machine learning, says Nicholas Diamond at C&M International.

• What DOJ's Cyberfraud Initiative Means For Health Cos.

  

  Though the U.S. Department of Justice's new cyberfraud initiative does not single out the health care industry, health and life sciences companies may be subject to heightened scrutiny under the False Claims Act and should prepare accordingly, say attorneys at Ropes & Gray.

• How Medical Device Cos. Can Limit Enforcement, Legal Risks

  

  With recent cases highlighting the myriad consequences that compliance failures can bring to medical device manufacturers, it is imperative that companies take proactive steps to avoid U.S. Food and Drug Administration enforcement and pay particular attention to keeping warning letters out of evidence in product liability suits, say attorneys at Phillips Lytle and Compliance Team.

• How Growing Cyber Scrutiny Affects Corporate Compliance

  

  In the face of overlapping cybersecurity initiatives at the U.S. Departments of Justice and Health and Human Services, health care companies and government contractors should prepare for microscopic scrutiny by ensuring specific components are included in compliance programs and being mindful of reporting obligations under existing corporate integrity agreements, say attorneys at Verrill Dana.

• Choosing The Right IP Protections For Telehealth Innovations

  

  Telemedicine and digital health innovations are likely to stay after the COVID-19 pandemic ends, so inventing companies must decide on a comprehensive intellectual property strategy, considering the goals, risks and upfront requirements offered by both patent and trade secret protections, say Eric Sophir and Matthew Horton at Foley & Lardner.

• A Phased Approach To In-House Legal Tech Adoption

  

  In-house legal departments that adopt new technologies too quickly often face frustration or failure, so to help ensure a smooth transition, companies should consider a multistep approach, depending on where they stand with respect to modernizing legal processes, says Tariq Hafeez at LegalEase Solutions.

• 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.