Memorandum of Understanding
Between
Health Information Sharing & Analysis Center, Inc.
(H-ISAC)
And
The U.S. Food and Drug Administration
Center for Devices and Radiological Health

I. Purpose

The United States Food and Drug Administration (“FDA”)’s Center for Devices and Radiological Health (“CDRH”) and Health Information Sharing & Analysis Center, Inc. (“Health-ISAC”) have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices. FDA and Health-ISAC are each referred to individually as a “Party” and collectively as the “Parties.” This Memorandum of Understanding (“MOU”) establishes the terms for collaboration to promote this shared interest.

II. Background

1. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“the Act”) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices, and radiological products and the safety and security of foods and cosmetics. CDRH is responsible for assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. To accomplish its mission, FDA takes efforts to stay abreast of the latest technological advances and developments in research by communicating with stakeholders about complex scientific and public health issues.

2. Health-ISAC, a non-profit organization, is the Information Sharing and Analysis Center (“ISAC”) for the nation’s healthcare and public health critical infrastructure, recognized by the U.S. Department of Health and Human Services (“HHS”), the HHS Health Sector Coordinating Council (SCC), the U.S. Department of Homeland Security (“DHS”), the National Council of ISACs (representing all the nation’s critical infrastructures ISACs), intelligence agencies, law enforcement, and the health sector.

Health-ISAC is a community of critical infrastructure owners with a system of security intelligence information exchange among trusted entities for the purposes of providing members with actionable cybersecurity for intelligence situational awareness, information sharing capabilities supporting effective countermeasure solutions, and coordinated cybersecurity incident response. As a non-profit organization, Health-ISAC represents a trusted community comprised of national healthcare and public health critical infrastructure owners and operators and the organizations supporting the health sector.
 
The mission of Health-ISAC is to empower trusted relationships in the global healthcare industry to prevent, detect, and respond to cybersecurity and physical security events to improve health and save lives.

3. Executive Order 13636 articulates that cyber threats continue to grow and are one of the most serious threats to national security. Furthermore, Presidential Policy Directive 21 tasks federal government entities with the responsibility to strengthen the security and resilience of critical infrastructure (e.g., the Healthcare and Public Health sector) against physical and cyber threats such that these efforts reduce vulnerabilities, minimize consequences, and identify and disrupt threats. As part of sector-specific cybersecurity initiatives, CDRH seeks to create a collaborative information-sharing environment and decision framework that reduces risks to the public's health and allows rapid sharing of medical device vulnerabilities, threats, and mitigations within the hospital and healthcare ecosystem. Health-ISAC, given its unique position as a non- profit organization, and its recognition by DHS, HHS, and the Healthcare and Public Health Sector Coordinating Council as the ISAC for the Healthcare and Public Health (“HPH”) Sector, is an essential partner in developing this collaborative information- sharing environment and decision framework. By leveraging the relationships that Health-ISAC has already developed with public and private sector stakeholders, it will be able to develop the specialized knowledge, processes and analytical capabilities needed to assess and drive cybersecurity vulnerability mitigation and threat mitigation in the HPH sector.

III. Goals of Collaboration

1. Create an environment that fosters stakeholder collaboration and communication, and encourages the sharing of information about cybersecurity risks that may affect the safety, effectiveness, and security of medical devices and their related systems, and/or the integrity and security of the surrounding healthcare information technology (“IT”) infrastructure. Ultimately, exploited vulnerabilities and other cyber risks may have downstream public health and patient safety consequences.

2. Create an environment that fosters stakeholder collaboration and communication, and encourages the sharing of certain medical device software supply chain information, including software bills of material (“SBOMs”), to enable the tracking, analysis, and response to potential cyber risks within such software supply chains that may affect the safety, effectiveness, and security of medical devices and their related systems, and/or the integrity and security of the surrounding healthcare IT infrastructure. Ultimately, cyber risks revealed by SBOMs and software supply chain information may have downstream public health and patient safety consequences.

3. Develop awareness of resources related to cyber risk management produced by the Health Sector Coordinating Council, the recognized critical infrastructure industry partner for the HPH sector, and enable HPH sector stakeholders to successfully adapt and operationalize these resources for their organizations and products.

4. Encourage stakeholders within the HPH Sector to develop innovative strategies to assess and mitigate cybersecurity vulnerabilities and other cyber threats that affect their products.
 
5. Build a foundation of trust within the HPH community (including but not limited to medical device manufacturers, end user facilities, providers, and healthcare organizations) so that all healthcare technology and medical device stakeholders can directly benefit from the sharing of cybersecurity vulnerability and/or threat information identified within the HPH Sector, as well as intelligence feeds from other Critical Infrastructure Sectors that may secondarily affect healthcare and the public health. Gaining timely situational awareness of cybersecurity vulnerabilities that can have negative consequences for patient safety provides stakeholders with an opportunity to share solutions in advance of potential harm and possibly prevent economic or 'brand' damage. It would further enable owners and operators of critical infrastructure to proactively take appropriate measures to strengthen cybersecurity within the HPH sector with accuracy and agility.

IV. Substance of the Agreement

1. FDA intends to establish a mechanism by which information regarding cyber risks and certain software supply chain information can be shared with Health-ISAC. This MOU does not authorize, and FDA does not intend to, share any confidential commercial, trade secret, or personal privacy information with Health-ISAC pursuant to this MOU.

2. Health-ISAC intends to work with its members and partners to establish a mechanism by which cyber risks and appropriate software supply chain information relevant to medical devices are shared broadly throughout the HPH and with FDA, such that the existing agreements among Health-ISAC members will not be infringed upon.

3. The Parties intend to work together to establish mechanisms to ensure that essential medical device or healthcare cyber risk and software supply chain information can be shared with all stakeholders within the HPH Sector, including those who are not members of Health-ISAC, to the extent consistent with applicable law. This collaboration will help inform a common understanding of that risk threshold upon which exploit of a vulnerability, threat, or software supply chain information might impact on patient safety and/or public health.

4. The Parties intend to collaborate to foster the development of cyber risk and software supply chain analytics that will enable stakeholders to preemptively detect and address cybersecurity risks before they impact the safety, effectiveness, or security of medical devices, or the integrity of the Healthcare IT infrastructure.

5. Each Party will establish a principal point of contact to facilitate the actions carried out under this MOU.

V. General Provisions

1. This MOU represents the broad outline of the Parties' intention to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future understandings or arrangements between the Parties and does not affect the ability of the Parties to enter into other understandings or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Health-ISAC operate.

2. Data Sharing Guidelines: The Parties may enter into separate Confidential Disclosure Agreements (“CDAs”) pertaining to certain data and information shared in accordance with this MOU. In accordance with applicable law and regulations, including, but not limited to, 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63,
as well as 21 CFR 20.85 and 21 CFR 20.88, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with Health- ISAC pursuant to this MOU.

VI. Liaison Officers:

A. For Health-ISAC
Jon Crosson
Director of Health Sector Resilience
226 North Nova Road, Suite 391
Ormond Beach, FL 32174
jcrosson@h-isac.org
or
Phil Englert
Vice President, Medical Device Security
226 North Nova Road Suite 391
Ormond Beach, FL 32174
penglert@h-isac.org

B. For the Food and Drug Administration
Suzanne B. Schwartz, MD, MBA
Director
Office of Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Building 66, Room 5434
Silver Spring, MD 20993
301-796-6937
Suzanne.Schwartz@fda.hhs.gov
or
Jessica Wilkerson, J.D.
Senior Cyber Policy Advisor and Medical Device Cybersecurity Team Lead
All-Hazards, Readiness, Response, and Cybersecurity Team
Division of All Hazards Response, Science and Strategic Partnerships
Office of Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
240-401-8691
jessica.wilkerson@fda.hhs.gov

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within two (2) weeks and notify the other Party through the designated administrative liaison.

VII. Term, Termination, and Modification:

This agreement, when accepted by all participating Parties, will have an effective period of performance of five (5) years from the date of the latest signature and may be modified or terminated by mutual written consent by both Parties or may be terminated by either Party upon a thirty (30) day advance written notice to the other.

Authorized Signatures

Approved and Accepted For
Health-ISAC, Inc. dba Health-ISAC
By: /s/
Denise Anderson
President & CEO
Date: 12/14/2023

Approved and Accepted For
U.S. Food and Drug Administration
Center for Devices and Radiological Health
By: /s/
Jeffrey Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Date: 12/14/2023