Foundation for Innovation Translation and Safety Science

Fitss will:-establish appropriate committees to identify and address specific issues;-ensure representation across government, manufacturers, providers, payers and broader technology companies including infrastructure, security, device components and services companies;-establish a public/private reporting infrastructure to accurately assess the national exposure and identify, track and trend incidents;-ensure the public/private surveillance and adverse incident response model protects the interests of patients, providers, manufacturers and regulators to protect the public;-develop case definitions for security risks and medical device associated adverse events;-develop a data collection network that support premarket clinical trials and postmarked adverse event surveillance;-leverage the data collection network to support Innovation in medical devices.fitss first project is the medical device Innovation, Safety and security consortium (mdiss) which is designed to protect the public health and well-being by advancing Innovation and computing risk management practices to ensure wide availability of Innovation and safe medical devices.on september 8, 2015, fitss' mdiss initiative received written notice that it was awarded a $1,800,000 grant from the department of homeland security to support an important public health initiative over a two year period. It will support mdiss activities that will bring Innovation to assessing risk of medical devices, providing near real-time insights into health care delivery organizations' (hdo) cybersecurity requirements, provide an efficient crowd-sourcing approach to assessing a large number of diverse medical devices that will be useful for the fda and for hdos; and linkage to a newly emerging medical device vulnerability information sharing initiative (a collaboration between fda, mdiss and national health information and analysis center (nhisac)). The grant will support Foundation work to improve the Science (including but not limited to risk assessment and analytics), and its immediate Translation into platforms and methods that will be made available to medical device stakeholders for free or low cost. The overall activity strengthens a critical Innovation community that has been doing critical work to better secure medical devices and their associated health care delivery networks. Our nation's entire healthcare system rests upon this nationally connected biomedical device network that, like the internet, was never planned or properly secured.examples of how this proposal will advance the goals of this broad agency announcement call include:1. The medical device regulatory affairs program (mdrap) through vanderbilt university will collect comprehensive information about the medical devices in the healthcare delivery system environment, or other environments. This will provide the data and information needed for manufacturers or healthcare delivery organizations to add the necessary security enhancements to the design and implementation of cps.2. Consistent with executive order 13636 and presidential policy directive 21, mdrap will collect and analyze data on cps so that the medical devices in healthcare delivery systems will be made more robust and strengthen our nation's health critical infrastructure.3. The medical device security data collected by mdrap will provide near real-time requirements to manufacturers about the needs of the implementers, healthcare delivery organizations. This will improve the quality of security controls at design phase as well as in the implementation phase.4. The medical device networks in health care delivery systems are complex and mdrap will help systems plan, architect, and operate safer medical device ecosystems as manufacturers ramp up the design, build and marketing of more secure devices.5. Mdrap, as it collects data on medical devices, will provide important insights into the security posture for biomedical devices themselves, the biomedical device networks, health system infrastructure and community-wide health infrastructure. This knowledge will help dhs and its stakeholders better prepare and respond to events.6. Finally, mdrap, as has been encouraged by department of homeland security and the white house, is driving market-based Innovation through highly collaborative processes that cross the public-private sectors. This consortium of medical device manufacturers, healthcare delivery organizations, technology companies, collaborations with government agencies will help accelerate identification of security challenges and collaborate on identifying their solutions.