MEMORANDUM OF UNDERSTANDING
AMONG TH FEDERAL COMMUNICATIONS COMMISSION,
THE OFFICE OF THE NATIONAL COORDINATOR
FOR HEALTH INFORMATION TECHNOLOGY,
AND THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
The Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC) and the Food and Drug Administration (FDA) as parts of the Department of Health and Human Services, all United States Federal Government entities and hereinafter also referred to as "agencies," agree to work together to promote a health information technology (IT) framework that promotes innovation, protects patient safety, and avoids regulatory duplication.
The FCC is an independent federal establishment created by the Communications Act of 1934, 47 U.S.C. § 151 et seq. The FCC is responsible for, among other things, governing radio devices so as to provide for effective operation and communication, including allocations of frequencies and specification of technical requirements to avoid harmful interference between users.
The ONC is the principal Federal entity charged with coordination of nationwide efforts to implement and use health information technology and the electronic exchange of health information. The position of National Coordinator was created in 2004 through Executive Order 13335 and legislatively established in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009.
The FDA is a regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including drugs, biological products, animal drugs, and medical devices. The FDA administers the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. § 321 et seq) and applicable sections of the Public Health Service Act (see 42 U.S.C. § 262), among other statutes. Among its duties, the FDA approves pre-market applications, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events.
The FCC enters into this MOU in furtherance of its responsibility to provide for effective operation and communication between radio devices, including allocation of frequencies and specification of technical requirements to avoid harmful interference between users. See 47 U.S.C. 151, 152, 301, 302
The ONC enters into this MOU in furtherance of its responsibilities to coordinate HHS health information technology policy and programs with those of other relevant executive branch agencies to avoid duplication of efforts and help ensure that each agency undertakes health IT activities primarily within the areas of its greatest expertise and technical capability. See 42 U.S.C § 300jj–11.
The FDA enters into this MOU in furtherance of its responsibilities related to the safety and effectiveness of medical devices, which include certain health IT. See 21 U.S.C. § 321.
The MOU among the agencies is intended to promote collaboration and to support development of a nationwide health IT infrastructure that promotes innovation, protects patient safety, and avoids regulatory duplication.
This MOU is designed to enhance knowledge and understanding among the agencies and to share information and expertise between the agencies for health IT. This MOU aims to:
1. Enhance the ways in which the agencies will exchange information with each other;
2. Demonstrate the agencies’ commitment to discuss safety issues that may involve more than one agency on an ongoing basis;
3. Establish mechanisms by which the agencies will coordinate relevant regulatory activities, guidance, and other policy development where there are mutual interests; and
4. Identify the procedures the three agencies will follow to address emergent technologies.
The agencies have long-standing, established mechanisms for collaboration. The FCC and FDA have conducted quarterly meetings and worked together to ensure that communications-related medical innovations can swiftly and safely be brought to market. Similarly, ONC and FDA have worked together to help promote the safe adoption of health IT.
The agencies have developed a collaborative working group to support the development of the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT report which proposes a health IT framework that promotes innovation, protects patient safety, and avoids regulatory duplication. The working group plans to continue working collaboratively and interactively on health IT-related activities to ensure an efficient, coordinated, transparent federal approach that actively engages and interacts with the stakeholder community on an ongoing basis.
This MOU is intended to enhance the coordination among the agencies with respect to health IT. It is anticipated that this will be an ongoing effort, and it may be followed by additional MOUs or amendments to this MOU.
VI. Substance of Agreement:
a. The agencies will establish mechanisms and expectations for the agencies to continue to collaborate and interact.
b. The agencies will coordinate with other Federal agencies involved in health IT as appropriate.
c. The agencies will provide ongoing opportunities for feedback, input and dialogue among health IT stakeholders.
d. The agencies will collaborate, where appropriate, in holding public meetings to gather information and perspective from all affected parties.
e. Each agency will name a liaison to facilitate the actions carried out under this MOU.
f. Each agency agrees to share information pursuant to the protocols established herein in Appendix A.
g. Each agency agrees to notify the others, pursuant to the protocols established herein in Appendix A, when each obtains information that it recognizes will be useful to the other agency(ies), in the performance of its duties or in its general knowledge and understanding of developments and regulatory concerns in the field of health IT.
h. The agencies agree that each initial contact will be made by and transmitted to the agency liaison designated according to Section VI.e. of this MOU. Subsequent communications pertaining to that issue may occur between other staff as outlined in the initial request for information.
i. The agencies agree that each agency may decide, in its discretion whether it will share information or expertise in response to a particular request for information made according to the procedures established under Section VI.f., or to limit the scope of information and expertise sharing in response to a particular request. A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding agency’s priorities, or legal restrictions. In the event that the agencies can not reach consensus on a decision to share or not share information, the issue will be referred to the respective agency signatory for resolution.
j. The agencies agree to establish reasonable timelines for responding to information requests and to refer instances of delays to the agency liaison officer for resolution.
VII. General Provisions:
The FCC, FDA, and ONC shall utilize procedures that include proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. Proper safeguards shall include the observation of policies and procedures that ensure that the information shared under this MOU shall be used solely in accordance with each agency’s respective statutory duties and responsibilities for the purposes outlined in Section IV, and in compliance with the Trade Secrets Act (18 U.S.C. 1905), the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Freedom of Information Act (5 U.S.C. 552), 44 U.S.C. 3510, and their implementing regulations, as well as the HIPAA Privacy Rule (45 CFR Parts 160 and 164). The ONC, FCC and the FDA shall utilize appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of information governed by the above statutes, as well as internal agency information, and to prevent unauthorized access to the information provided by the other agency.
Access to confidential information shared under this MOU shall be restricted to authorized FDA, ONC and FCC employees, agents, and officials who require access to perform their official duties in furtherance of the provisions and the objectives of this MOU. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards required to protect the information, and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors, their subcontractors, and agents requiring access to the information shared under this agreement, in order to perform their duties for one of the parties to this MOU, must sign the appropriate confidentiality or nondisclosure agreement required by the agency providing the information. By signing such an agreement, contractors, their subcontractors, and agents will commit to keep the information confidential. Authorized use of derivative works that include such confidential information shall observe the same practices as described in Section VII of this MOU with respect to the confidential information contained therein.
The FCC, FDA, and ONC agree to promptly notify the other agency of any actual or suspected unauthorized disclosure of information shared under this MOU.
If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for the shared information, it will immediately refer the request to the information-originating agency, via the designated liaison identified below, for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency. If an agency receives a FOIA request for a document that it has generated and which includes information received under this MOU, the agency shall consult with the providing agency before acting on the FOIA request.
If an agency that has received information under this MOU receives a subpoena that may cover the shared information, it will immediately notify the information-originating agency, via the designated liaison officer identified below, and the two agencies will confer on how to respond.
VIII. Resource Obligations:
This MOU represents the broad outline of the agencies’ intent to enter into specific agreements for collaborative efforts in areas of mutual interest to the FCC, FDA, and ONC. This MOU shall not be construed to obligate any particular expenditure or commitment of funds and/or resources. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing agreements or arrangements among the agencies and does not affect the ability of the agencies to enter into other agreements or arrangements related to this MOU. The FCC, FDA, and ONC agree to take actions under this collaboration that are consistent with existing laws and regulations, and that nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by the FCC, FDA, and ONC including but not limited to: Title 42 of the United States Code, the Federal Food, Drug, Cosmetic Act, Title 47 of the United States Code, and the Communications Act of 1934. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on FCC, FDA, or ONC that is additional to the mandates or requirements imposed on the FCC, FDA or ONC by Federal statutes and regulations.
A. For the Federal Communications Commission:
Director of Healthcare Initiatives
445 12th St, SW, Washington, DC 20554
B. For the Food and Drug Administration:
10903 New Hampshire Ave
WO 66, RM 5456
Silver Spring MD 20993
C. For the Office of the National Coordinator:
Director, Federal Policy Division, Office of Policy and Planning
355 E Street, SW
Washington, DC 20024
X. Term, Termination, and Modification:
This agreement will be effective when accepted by the Agencies. This agreement may be modified or terminated by mutual written consent by the Agencies at any time, or may be unilaterally terminated by any of the agencies upon a ninety-day advance written notice to the others.
APPROVED AND ACCEPTED FOR APPROVED AND ACCEDPTED FOR
THE FEDERAL COMMUNICATIONS COMMISSION THE FOOD AND DRUG ADMINISTRATION
Jeff Shuren, M.D., J.D.
Acting Managing Director
Federal Communications Commission
Center for Devices and Radiological Health
April 22, 2014
April 17, 2014
APPROVED AND ACCEPTED FOR
OFFICE OF THE NATIONAL COORDINATOR
FOR HEALTH INFORMATION TECHNOLOGY
Karen B. DeSalvo, MD, MPH, MSs
National Center for Health Information Technology
April 20, 2014
Process for Information Sharing
Pursuant to Section VI.i. of the Memorandum Of Understanding (MOU) entered into by the Federal Communications Commission (FCC), the Office of National Coordinator (ONC), and the Food and Drug Administration (FDA), each agency “may decide, in its discretion whether it will share information or expertise in response to a particular request for information made according to the procedures established under Section VI.f., or to limit the scope of information and expertise sharing in response to a particular request.” Nothing in the process described below changes Section VII.
When, under the current MOU, staff at the FCC, ONC, or FDA request from one of these agencies the other agencies information that may contain confidential material, the request should be in writing, which includes an informal email, and need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:
"Handling of information shared under this request will be governed by the terms of the 2014 FCC-ONC-FDA Memorandum of Understanding to Share Information. We agree not to disclose any shared information except as provided therein.” With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.
A response to a request should also be in writing, but it, too, can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response:
"Pursuant to the 2014 FCC-ONC-FDA Memorandum of Understanding to Share Information, this communication may contain privileged and/or confidential information exempt from public disclosure. “It may not be disclosed or shared in any manner except as provided by the 2014 FCC-ONC-FDA Memorandum of Understanding to Share Information.” With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.