The agency will be focusing on driving synergy for digital health efforts and aligning strategy while maintaining FDA standards of safety and effectiveness.
Digital Health Center of Excellence (DHCoE) goals:
Areas of Focus:
The following documents are on The A-list (A list of prioritized device guidance documents the FDA intends to publish during FY2021).
* The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products1 that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions.
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) The Office for Civil Rights reached a settlement with the Athens Orthopedic Clinic for $1.5 million over a 2016 data breach caused by the notorious hacking group known as “thedarkoverlord” (TDO). TDO stole the data of more than 655,000 patients, including the Athens Orthopedic.
A journalist notified Athens Orthopedic that a database of their patient records may have been posted online for sale. Two days later, TDO contacted the clinic and demanded payment in order for the complete patient records to be returned.
OCR’s investigation discovered longstanding, systemic noncompliance with the HIPAA Privacy and Security Rules by Athens Orthopedic including failures to conduct a risk analysis, implement risk management and audit controls, maintain HIPAA policies and procedures, secure business associate agreements with multiple business associates, and provide HIPAA Privacy Rule training to workforce members.
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