The FDA is increasing its focus on cybersecurity risks associated with medical devices, requiring manufacturers to implement robust security measures to protect patient data and device functionality from cyber threats.

The FDA is increasingly using real-world evidence (RWE) to support medical device approvals and post-market surveillance, requiring manufacturers to collect and analyze data from real-world settings to demonstrate product safety and effectiveness.

The Health Insurance Portability and Accountability Act (HIPAA) sets standards for protecting sensitive patient health information. Compliance requires robust data security and privacy measures to safeguard patient data from unauthorized access and disclosure. It mandates a Privacy Rule, Security Rule, and Breach Notification Rule, impacting how covered entities and their business associates handle protected health information (PHI). The Department of Health and Human Services (HHS) is responsible for enforcing HIPAA and its regulations. Non-compliance can result in significant penalties, including fines and legal action. Regular audits and updates to privacy practices are essential for maintaining HIPAA compliance in the evolving healthcare landscape. This is a summary for educational purposes only and should not be considered legal advice. Always consult with a legal professional for HIPAA compliance guidance pertaining to your organization and specific situation. This explanation is not a substitute for professional legal counsel.