On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more
10/11/2017
/ Algorithms ,
Carbon Monoxide Exposure ,
Endorsements ,
Enforcement Actions ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Mobile Health Apps ,
Settlement Agreements ,
Substance Abuse ,
Unfair or Deceptive Trade Practices
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
9/18/2017
/ App Developers ,
COPPA ,
Cybersecurity ,
Data Privacy ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Intellectual Property Protection ,
IP License ,
Medical Devices ,
Mobile Health Apps ,
Mobile Medical Applications ,
Software ,
Unfair or Deceptive Trade Practices
In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more
Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more