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- Title
THE REGULATORY ARMS RACE: MOBILE-HEALTH APPLICATIONS AND AGENCY POSTURING.
- Authors
Schulke, Daniel F.
- Abstract
Mobile-health applications are largely unregulated by the federal government. These applications have tremendous potential to reduce the costs of caring for chronic disease patients. This is particularly true in rural communities where mobile-health applications could increase patient engagement and improve the quality of care. While these applications can be helpful in transforming and improving patient care, unregulated applications may harm patients or unintentionally release protected health information. The U.S. Food and Drug Administration (FDA) has asserted jurisdiction over some mobile-health applications as medical devices. FDA, however, lacks experience regulating the data security and interoperability of devices -- an area in which the Office of the National Coordinator for Health Information Technology (ONC) has substantial experience. This Note explores several frameworks for regulating mobile-health applications as well as the advantages and disadvantages of each framework. This Note concludes by proposing two separate regulatory frameworks for mobile-health applications with different agencies responsible for each framework. Ultimately, FDA should use its authority to regulate the clinical safety and effectiveness of mobile-health applications because of the substantial health risks that they pose to patients. While data security, and to a lesser extent interoperability, is an important consideration in safeguarding patients, private regulators operating under the supervision of ONC should have the ultimate responsibility for implementing protections in these areas.
- Subjects
UNITED States; MOBILE health; MEDICAL care; GOVERNMENT regulation; UNITED States. Food &; Drug Administration; JURISDICTION; UNITED States. Office of the National Coordinator for Health Information Technology; DATA security
- Publication
Boston University Law Review, 2013, Vol 93, Issue 5, p1699
- ISSN
0006-8047
- Publication type
Article