The Food and Drug Administration
Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices.
All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks. While the increased use of wireless technology and software in medical devices also increases the risks of potential cybersecurity threats, these same features also improve health care and increase the ability of health care providers to treat patients.
Addressing cybersecurity threats, and thus reducing information security risks, is especially challenging. Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them. There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance. The FDA looks for and encourages reports of cybersecurity issues through surveillance of devices already on the market FDA recommendations for mitigating and managing cybersecurity threats include:
The FDA’s ongoing efforts to protect the public health from cybersecurity vulnerabilities include:
To establish mechanisms by which information regarding medical device cybersecurity vulnerabilities and threats can be shared with the NH-ISAC, MDISS, and FDA in a trusted space; and
To foster the development of a shared risk assessment framework to enable stakeholders to consistently and efficiently assess patient safety and public health risks associated with identified cybersecurity vulnerabilities, and take timely and appropriate action to mitigate the risks.
The FDA issued three product-specific safety communications discussing cybersecurity vulnerabilities:
In each of the above cases, the FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, nor are we aware that any specific devices or systems in clinical use have been purposely targeted. However, these vulnerabilities could allow unauthorized users to remotely access, control, and issue commands to compromised devices, potentially leading to severe patient harm. Health care facilities can reduce the risk of unauthorized access by implementing recommendations in the safety communications.
On October 29, 2014, the FDA held a webinar on the guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Stakeholders were invited to learn more about the guidance and ask questions. The final guidance, issued on October 2, 2014, contains recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement the following FDA guidance documents:
On October 21-22, 2014, the FDA held a public workshop, Collaborative Approaches for Medical Device and Healthcare Cybersecurity, to seek input from the health care and public health sector on medical device and health care cybersecurity. The goals of the workshop were to encourage collaboration among stakeholders, identify challenges and discuss strategies and best practices for promoting medical device cybersecurity.
On June 13, 2013, the FDA issued a safety communication, Cybersecurity for Medical Devices and Hospital Networks, in which the FDA recommends that medical device manufacturers and health care facilities take steps to ensure that appropriate safeguards are in place to reduce the risk of device failure due to cyber attack.
Link: http://www.fda.gov/medicaldevices/digitalhealth/ucm373213.htm