FDA / Regulatory News
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:
- moving health care from the Clinic to the Patient
- understanding patient’s behavior and psychology “In the wild”
- focusing on prevention for early/smaller interventions
Areas of Focus:
- SaMD, AI
- Wearables
- SiMD (Software in a medical device)
- Cybersecurity
- Wireless Connectivity
- Digital Biomarkers and Pathology
- and more…
Timeline:
- Phase 1 (Fall 2020) – Communication (Raise Awareness and Engage Stakeholders)
- Phase 2 (Fall and Winter 2020) – Coordinate (Build Partnerships. Assemble FDA advisory groups)
- Phase 3 (Winter 2021 onwards) – Amplify (Build and Sustain Capacity)
The following documents are on The A-list (A list of prioritized device guidance documents the FDA intends to publish during FY2021).
Final Guidance:
- Surgical Staplers
- Safer Technologies Program for Medical Devices*
- Clinical Decision Support Software
- Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
- Product Labeling for Laparoscopic Power Morcellators
Draft Guidance:
- Post-market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
- Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
- Computer Software Assurance for Manufacturing and Quality System Software (this is CSV, Computer Software Validation like Jama etc.)
- Remanufacturing of Medical Devices
- Case for Quality Voluntary Improvement Program
- Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
- Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization (EUA) During the COVID-19 Public Health Emergency
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices
- Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
- Content of Premarket Submissions for Software Contained in Medical Devices
- Electronic Submission Template for Premarket Notification (510(k)) Submissions
* 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.
Data Privacy / HIPAA
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.
