- Medical device security will become an increasing concern for healthcare organizations, particularly as more of these devices are connected to the Internet, internal networks, and Wi-Fi, predicted a new report by Transparency Market Research.
The increasing connectedness of these medical devices will force more and more healthcare organizations to implement security solutions. This will fuel demand for the connected medical devices security market, the report noted.
At the same time, lack of awareness among healthcare professionals about the availability and benefits from these security solutions could affect the demand in the connected medical devices security market, the report cautioned.
With the greater adoption of connected medical devices, a new hostile environment has emerged posing threats to the security of these devices and the healthcare organizations that use them. This has created an increasing need for security of connected medical devices to protect against unauthorized access and cyberattacks, the report observed.
Some of the major players in the field of connected medical devices security include UL, Whitescope, Battelle, Coalfire Systems, Drager Medical, Extreme Networks, and Synopsys, according to Transparency Market Research.
On a regional basis, the connected medical devices security market can be segmented into seven key regions: North America, Latin America, Western Europe, Eastern Europe, APEJ, Japan, and Middle East and Africa.
The connected medical devices security market in North America is expected to dominate because of strong presence of companies from the healthcare industry and companies providing connected medical devices security solutions in the region.
The FDA has issued guidance for connected medical devices security that should spur medical device manufacturers to implement a set of practices ensuring the security of medical devices from cyberattacks and unauthorized access.
The FDA’s guidance for implementation of connected medical devices security supported by increasing awareness among healthcare professionals about the need to implement these security solutions will drive the market, the report predicted.
The FDA also issued a medical device security action plan earlier this year. In the action plan, the FDA describes steps it plans to take in the following areas:
• Establish a medical device patient safety net
• Explore regulatory options to streamline implementation of postmarket mitigations
• Spur innovation towards safer medical devices
• Improve medical device cybersecurity
• Integrate the Center for Devices and Radiological Health's premarket and postmarket offices and activities to expand the use of a total product life cycle approach to device safety
The FDA said it was exploring steps it could take to spur innovation in medical devices. The agency’s Breakthrough Device Program could be used to improve patient access to innovative new devices and patient safety at the same time. In addition, a similar program just for innovations in device safety is under consideration.
In addition, the agency is asking Congress to expand its authority and funding to improve medical device safety, including reducing cybersecurity vulnerabilities in devices.
The FDA wants to set up a CyberMed Safety (Expert) Analysis Board—a public-private partnership between the FDA and devices makers to complement existing device vulnerability coordination and response mechanisms.
The board would include individuals with expertise in hardware, software, networking, biomedical engineering, and clinical environments.
The American Hospital Association has asked the FDA to include healthcare providers on the board. AHA said that providers “stand to benefit from the Board’s expertise on how to assess vulnerabilities, evaluate patient safety risks, assess proposed mitigations, and the other functions described in the safety plan.”
The board would assess vulnerabilities, evaluate patient safety risks, adjudicate disputes, assess proposed mitigations, serve as consultants to organizations navigating the coordinated disclosure process, and function as a “go-team” that could be deployed in the field to investigate a suspected or confirmed device compromise.
All this FDA action should help to further fuel growth in the medical device security market.