Expert Analysis

• How To Minimize Risk When Launching Smart Medical Devices

  

  Prior to launching a smart medical device, there are several critical steps that companies can take in order to protect their intellectual property, get approval from the U.S. Food and Drug Administration and ensure the safety of their data, say attorneys at Crowell & Moring.

• Health Issues To Watch In Inflation Act, Other Policy Initiatives

  

  The newly signed Inflation Reduction Act includes a number of significant drug pricing reforms, and the future holds a wider array of health issues that may be addressed in pending legislation when Congress returns in September, says Miranda Franco at Holland & Knight.

• DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

  

  The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.

• Digital Health Cos. Should Expect More Scrutiny Amid Growth

  

  As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.

• Anti-Kickback Circuit Split Holds Implications For Defendants

  

  The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.

• Post-Dobbs HHS Guidance Brings Privacy Considerations

  

  The U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, and ensuing guidance from the U.S. Department of Health and Human Services, will create new privacy compliance issues for health care providers and other companies collecting personal information concerning the use of reproductive health services, say attorneys at Ropes & Gray.

• HHS Fraud Alert Is A Major Warning To Telehealth Industry

  

  The U.S. Department of Health and Human Services recently issued a rare fraud alert, indicating potential changes in telemedicine enforcement, and suggesting that digital health entities are likely to face subpoenas, civil investigative demands and other inquiries, say attorneys at Hooper Lundy.

• FDA Medical Device Cyber Guidance Protects Patients, Cos.

  

  By carefully following the U.S. Food and Drug Administration regulations on cybersecurity for medical devices — including its latest guidance on premarket submissions — and anticipating, tracking and fixing vulnerabilities, manufacturers can reduce risks to patients, as well as their own risks of product liability and data breach claims, say attorneys at Dechert.

• The State Of Digital Health Care's Pandemic Transformation

  

  Two years into the COVID-19 pandemic, tech companies are helping to drive the health industry's transition into a new era of greatly expanded digital health and remote care, though some new challenges involving system compatibility and cybersecurity have arisen as well, says Carter Gage at Sheppard Mullin.

• Readying Cybersecurity Protocols For The Quantum Age

  

  As there is a significant likelihood that quantum computers will be able to break the majority of current encryption methods within the next decade, organizations should make preparations now to transition to post-quantum security mechanisms, says Ryan McKenney at Orrick.

• 2 FCA Settlements Highlight Gov't Cyber Liability Focus

  

  Recent False Claims Act settlements with Comprehensive Health Care Services and Aerojet Rocketyne illustrate government contractors' growing cybersecurity liability, and underscore how important it is for companies to comply with new incident reporting regulations and live up to standing contractual obligations, say attorneys at O'Melveny.

• What CMS E-Records Proposal Means For Hospitals

  

  The Centers for Medicare & Medicaid Services has proposed significant changes to the Medicare Promoting Interoperability Program — including increasing transparency through public reporting and requiring history queries of prescription drug monitoring programs — that will have far-reaching ramifications for participating hospitals, say Christine Moundas and Gideon Palte at Ropes & Gray.

• How To Protect Health Care Trade Secrets With Covenants

  

  Post-employment restrictive covenants such as noncompetes are an effective way for health companies to protect confidential information and trade secrets, but employers must be cognizant of the rapidly changing state laws governing the enforceability of such agreements, say Erik Weibust and Katherine Rigby at Epstein Becker.