Digital health in the United States is rapidly and continuously evolving to enhance patient
care and revolutionize health care delivery. This technology offers substantial promise to
both patients and providers, but lacks a comprehensive regulatory structure to ensure adequate
safety and privacy. While the Department of Health and Human Services, the Food
and Drug Administration, and the Federal Trade Commission regulate portions of the
digital health industry, their oversight is incomplete, with numerous digital health companies
falling between the cracks and assuming an unregulated status. This article analyzes
the state of digital health legal and regulatory oversight in the United States, discusses how
state legislatures and industry organizations have worked to fill existing legal gaps, and
presents strategies for encouraging compliance for unregulated entities.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:32046 |
| Date | 26 October 2018 |
| Creators | Nahra, Kirk J., Corbin, Bethany A. |
| Publisher | Universität Leipzig, University of Miami |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/acceptedVersion, doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | urn:nbn:de:bsz:15-qucosa2-320423, qucosa:32042 |
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