From Health and Human Services (HHS)
According to the report, the FDA had not adequately assessed the risk that cybersecurity in medical devices can pose, which is what led to these weaknesses.
Digital diagnostics linked to smart phones, smart medical devices, and big data have the potential to revolutionize medical dental care and improve the human condition. In my opinion they also offer the best solution to the health care crisis which is not really a “care” crisis but an affordability crisis.
Sadly cyber criminals have proven to be remarkably inventive and ares sure to exploit security vulnerabilities in medical devices. Vendors do need to be aware and address these issues.
On the other hand the final sentence is:
The safety announcement noted that “there have been no reports of patient harm related to these cybersecurity vulnerabilities.”