Medical Device Safety and Security (MeDSS)

Medical device risks are evolving

The safety of medical devices has long been a concern of patients, health care delivery organizations, regulators, and the manufacturers. Through innovation, the definition of medical devices, and associated capabilities, have expanded, introducing a new risk area and an imperative consideration when determining the safety and trustworthiness of a medical device: cybersecurity.

Because of the risks to safety and privacy, cybersecurity threats demand attention and organizations should balance transforming patient care with associated risks.

Appropriate protections – by design

Regulators such as the United States Food and Drug Administration (FDA), European Union (EU) Parliament, and China FDA have issued regulations, guidance, and standards so that appropriate protections are built into medical device by design. However, the operating environment of connected medical devices are highly dynamic, marked by threats that change from one day to the next.

In addition to embedding cybersecurity, privacy, and safety in premarket product development, manufacturers should consider post-market through ongoing and proactive threat and vulnerability monitoring and risk management in coordination with health care delivery organizations.

Health care delivery organizations should also embed security into their product lifecycle processes, starting from when the identify and vet vendors to assessing if particular products meet their product security and privacy requirements, to securely onboarding and using those devices in a clinical setting.

We can help – across the health care ecosystem

Deloitte’s Medical Device Safety and Security (MeDSS) solutions can help entities in the health care ecosystem—medical device manufacturers, health care delivery organizations, third-party software providers, and digital health companies—support better patient outcomes by lowering the risks that come along with advanced medical technology through:

• Identify and helping remediate cybersecurity and privacy gaps across the device lifecycle through security and privacy-by-design principals 
• Conduct vigilant post-market surveillance
• Help establish and maintain a resilient supporting infrastructure

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