FDA Regulation of Mobile Apps – Sure You are Fully Covered?

The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe? Can someone hack an app you rely on for life supporting / life sustaining medical care? Yes. Patients and caregivers receive and install “app updates” with no idea what just happened and place themselves and even others in jeopardy. FDA has started to implement a regulatory approach and is overwhelmed now with that task. How much can FDA do? How will you know about the risks faced by the healthcare sector and you as an individual?

FDA is not the only regulatory stakeholder. The FTC exercises overlapping regulation. Are the two agencies in-sync with each other? Each agency is concerned about false or misleading claims. Marketers of standalone medical app software may have no clue about the FTC’s and FDA’s regulatory purview and enforcement authority over how a mobile app is marketed. That knowledge gap can be brutal, expensive and bring your business to a standstill.

Areas Covered in the Session :

• FDA Strategy and Policy
• Medical App Definition
• Institutional and Home Use Risks
• Cybersecurity
• Labeling Claims
• Enforcement

Who Should Attend:

• Regulatory Affairs Departments
• Quality Assurance Departments
• Software Design Engineers
• Manufacturing Departments
• Complaint Departments
• Hospital Risk Departments
• Software Program Marketers
• IT Security Departments
• Marketing Departments
• Home Healthcare Services
• Healthcare Information Protection
• Capital Venture Firms
• Medical Device Consultants

Course Director: CASPER E. ULDRIKS ‎

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.