• Search in Protiviti.com

Collaborative Security for Medical Devices – Best Practices for Device Manufacturers and Healthcare Delivery Organisations

Download

The proliferation of connected medical devices continues to introduce new cybersecurity risks that could impact patient safety and the security and privacy of patient data. To address these challenges, it is imperative that medical device manufacturers (MDMs) and healthcare delivery organisations (HDOs) collaborate effectively and prioritise medical device security (including design, implementation and maintenance) as a key priority for both entities. HDOs and MDMs can draw on guidance from the U.S. Food and Drug Administration (FDA), as well as industry standards from the National Institute on Standards and Technology (NIST) and key regulatory requirements like the Health Insurance Portability and Accountability Act (HIPAA) Security Rule as best practices.

Download
  1. Cybersecurity | U.S. Food and Drug Administration (FDA)
  2. NIST Cybersecurity Framework
  3. ISO 14971:2019; Medical devices — Application of risk management to medical devices
  4. NEMA - Manufacturer Disclosure Statement for Medical Device Security (MDS2)
  5. MedISAO (Medical Information Sharing and Analysis Organisation)
  6. H-ISAC (Health Information Sharing and Analysis Center)
  7. HIMSS (Healthcare Information and Management Systems Society)
  8. MDIC (Medical Device Innovation Consortium)
  9. HHS 405(d) Programme: A collaborative effort between the Health Sector Coordinating Council and the federal government
  10. Health Sector Coordinating Council Cybersecurity Working Group
  11. Archimedes Center for Medical Device Security
  12. Principles and Practices for Medical Device Cybersecurity - IMDRF
  13. There’s a Culture Shift Happening in Medical Device Manufacturing. Are CISOs Ready?
  14. Global Medical Device Company Assembles the Right Team and Microsoft Azure and IoT Solutions to Revolutionise Patient Care
  15. Top Security Pitfalls for Medical Devices at Healthcare Providers
  16. NIST Securing Internet Connected Medical Devices
Loading...