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Meeting the Challenges of Security and Privacy Whe ...
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The document discusses the challenges of security and privacy when using digital technology tools for Serious Mental Illness (SMI) care. It highlights the importance of ensuring the safety of health and clinical data, as well as the regulations outlined by the Health Insurance Portability and Accountability Act (HIPAA) for digital technologies in SMI care. The document also addresses the evolving role of the Food and Drug Administration (FDA) in regulating digital technologies for SMI care and provides examples of apps that fall outside of HIPAA regulations. It emphasizes the need for a rapidly changing regulatory environment and mentions the FDA's Pre-Cert program, which aims to provide more streamlined regulatory oversight for software-based medical devices. The document concludes with the American Psychiatric Association's (APA) app evaluation framework and thanks the reader.
Keywords
Security challenges
Privacy concerns
Digital technology tools
Serious Mental Illness care
Health data safety
HIPAA regulations
FDA regulations
Digital technologies in SMI care
Regulatory environment
FDA Pre-Cert program
Funding for SMI Adviser was made possible by Grant No. SM080818 from SAMHSA of the U.S. Department of Health and Human Services (HHS). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, SAMHSA/HHS or the U.S. Government.
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