MOU 225-14-0019

MEMORANDUM OF UNDERSTANDING
BETWEEN THE 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 the Health Information Sharing & Analysis Center, Inc. (H-ISAC) have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.   The purpose of this collaboration is to establish a basis upon which to foster and improve the safety of medical devices from cybersecurity threats.  Both FDA and H-ISAC are referred to individually as a “Party” and collectively as the “Parties.” This Memorandum of Understanding (MOU) establishes the framework for collaboration between the Parties to promote this shared interest.

II. Background: 

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 ensuring 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.

1. H-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 US 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.
   
   H-ISAC is a member-driven 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, H-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 H-ISAC is to enable and preserve the global public trust by advancing health sector cyber and physical resilience and the ability to prepare for and respond to cyber and physical threats and vulnerabilities. 

2. Executive Order 13636 (“Improving Critical Infrastructure” issued February 12, 2013) articulates that cyber threats continue to grow and are one of the most serious threats to national security. Furthermore, Presidential Policy Directive 21 (“Critical Infrastructure Policy and Resilience” dated February 12, 2013) 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, the parties seek to create a collaborative information-sharing environment and decision framework that reduces risks to the public health and allows rapid sharing of medical device vulnerabilities, threats, and mitigations within the hospital and healthcare ecosystem.     
   
   H-ISAC, given its unique position as a non-profit organization, and it’s recognition by DHS, HHS, and Healthcare SCC 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 H-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 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 vulnerabilities that may affect the safety, effectiveness and security of the medical devices, and/or the integrity and security of the surrounding healthcare IT infrastructure. Ultimately, exploited vulnerabilities may have downstream public health and patient safety consequences.
2. Develop awareness of the Voluntary Cybersecurity Framework (established by the National Institute for Standards and Technology, herein referred to as NIST), and enable H-ISAC members within the HPH sector to successfully adapt and operationalize the framework for their organizations and products.
3. Encourage stakeholders within the HPH Sector, to develop innovative strategies to assess and mitigate cybersecurity vulnerabilities that affect their products.
4. Build confidence within the HPH community (including but not limited to medical device manufacturers, end user facilities, providers and healthcare organizations) so that H-ISAC members 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 publicly available information regarding cybersecurity vulnerabilities and threats can be shared with H-ISAC. This MOU does not authorize, and FDA does not intend to, share any confidential commercial, trade secret, or personal privacy information with H-ISAC pursuant to this MOU. 
2. H-ISAC intends to work with its members to establish a mechanism by which cybersecurity vulnerabilities relevant to medical devices are shared with FDA, such that the existing agreements among H-ISAC members will not be infringed upon.
3. The parties intend to work together to establish how stakeholders can interface with FDA regarding medical device or healthcare cybersecurity vulnerability information-sharing. This collaboration will help inform a common understanding of that risk threshold upon which exploit of a vulnerability might impact on patient safety and/or public health.
4. The parties intend to collaborate to develop a shared understanding of the risks posed by cybersecurity vulnerabilities to medical devices. The parties also intend 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, appropriate action to mitigate the risks. This approach will also enable stakeholders to provide timely situational awareness to the HPH community and take efforts to preemptively address the cybersecurity vulnerability through appropriate mitigation and/or remediation before it impacts the safety, effectiveness or security of medical devices, or the integrity/security of the Healthcare IT infrastructure.
5. Each Party’s Liaison Officers 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 H-ISAC operate.  Nothing in this MOU alters the statutory authorities or obligations of FDA/CDRH.  The Parties recognize that this MOU is not intended to and may not be relied on to create any right or benefit, substantive or procedural, enforceable by law by any party against the Parties. 
2. Data Sharing Guideline: 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, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with H-ISAC pursuant to this MOU. 

VI. Liaison Officers:

 
A. For the H-ISAC
 
Denise Anderson
President and CEO
H-ISAC

226 North Nova Rd. #391
Ormond Beach, FL 32174
danderson@h-isac.org  
703-476-6036  

or

Errol Weiss
CSO
H-ISAC
226 North Nova Rd. #391
Ormond Beach, FL 32174
eweiss@h-isac.org
703-623-9273
 
B. For the U.S. Food and Drug Administration 
 
Suzanne Schwartz, MD, MBA
Deputy Director
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Building 66, Room 5410
Silver Spring, MD 20993
301-796-6937
suzanne.schwartz@fda.hhs.gov

or
 
Aftin Ross, PhD
Senior Project Manager
All-Hazards Readiness Response and Cybersecurity (ARC)
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Building 66, Room 5558
301-796-5679
aftin.ross@fda.hhs.gov 

The liaison officer for each Party will be responsible for identifying a point of contact that will be responsible for facilitating exchanges of information and expeditiously informing other interested parties within each respective organization on matters requiring prompt attention.  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.  Such notification of a new liaison shall constitute an amendment to and not require a revision of this agreement.
 
VII. Term, Termination, and Modification:
 
This MOU, 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.
 

APPROVED AND ACCEPTED
H-ISAC
 

 

/s/

_______________________________________________________________________

Denise Anderson
President and CEO

 

Date:  _____January 31, 2020____________

 

APPROVED AND ACCEPTED
U.S. FOOD AND DRUG ADMINISTRATION
 

/s/

_______________________________________________________________________

Jeffrey Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Date:  _____February 3, 2020____________