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MOU 225-11-0029



I. Preamble:

This Memorandum of Understanding (“MOU”) between the U.S. Food and Drug Administration (“FDA”) and MedStar Health, Inc. (“MedStar”), individually and by and through its wholly owned subsidiaries, MedStar Institute for Innovation (“MII”) and National Center for Human Factors Engineering in Healthcare (“NCHFEH”), is established to develop collaboration between the two parties in the areas of education, research, risk assessment, patient safety, and outreach in the area of human factors engineering in health care.

II. Purpose:

The objectives of this collaborative relationship resulting from this MOU include:

1. Development of a collaborative working relationship between the FDA, MedStar and its facilities and subsidiaries, the NCHFEH and MII.
2. Provision of exchange of graduate and undergraduate students, medical residents, fellows, faculty, and personnel, for the purposes of advanced training, research, technical evaluation, and outreach.
3. Stimulation of cooperative activities, research, civic engagement, and information exchange in areas such as medicine, health sciences, nursing, biomedical engineering, biostatistics, epidemiology, health policy, risk assessment, patient safety, human factors, computational modeling, high performance computing, healthcare systems engineering, usability of medical products, information technology, project management, and business administration.
4. Development of training programs for the FDA and potentially other government agencies, the healthcare products industry and healthcare professionals and users of medical products in the broad areas of medicine, health sciences, nursing, biomedical engineering, systems engineering, human factors, simulation and other product evaluation methods, patient safety, project management, business administration, and health policy.

III. Background:

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“Act”) as amended (21 U.S.C. § 301). 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, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics.  To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, technical evaluation (or risk assessment methods), and outreach partnerships with NCHFEH, MII and MedStar will greatly contribute to FDA’s mission.
The NCHFEH is a research and consulting center housed within a (nine) 9 hospital healthcare system and is associated with the MedStar Health Research Institute (“MHRI”), MII, and MedStar. The NCHFEH offers significant expertise in human factors engineering, medical devices, and usability. NCHFEH faculty includes two PhD-prepared human factors engineers, a practicing physician with a Masters degree in human factors engineering, a diverse group of associated faculty, and support staff. NCHFEH faculty members have extensive experience in applying usability and other human factors engineering techniques in the safety engineering and medical domains, and it is one of only a few human factors research centers in the US that are located within a hospital or healthcare system. Unique access to the clinical environment and faculty expertise of NCHFEH creates an ideal opportunity for collaboration.

IV. Substance of Agreement:

The MOU is intended as a broad vehicle to promote programmatic interaction in the form of joint collaboration between the FDA and NCHFEH and associated researchers, students, and personnel as well as joint development of relevant projects.

The collaboration may include the following:

Joint exchange program: The program would include internships, research opportunities, and shadowing opportunities for university undergraduate, graduate, and medical students, as well as MedStar medical residents and fellows at the FDA. Faculty and senior staff from the FDA, MedStar and its facilities and subsidiaries will be encouraged to participate in the work of the sister institutions for mutual research, technical evaluation and development, and training interactions.

Joint research programs: Joint research programs will be formed by scientists from the respective parties with mutual complementary interests.

Joint training activities: Training activities arising from complementary interests will be developed by NCHFEH  and offered to the FDA, industry, and others as identified needs arise.

Joint dissemination of information and outreach: The parties will disseminate information and enhance the visibility of the work of the collaboration through mutually agreed vehicles including training activities, meetings, and symposia.

Participants will include faculty and students from relevant departments at MedStar facilities and subsidiaries and in particular, the NCHFEH and its collaborative partners. Participants from the FDA may include scientists from the the Center for Devices and Radiological Health (CDRH) or other FDA Centers and investigators from the FDA Office of Regulatory Affairs.

V. General Provisions:

  • Data Sharing Guidelines:  The parties may enter into separate Confidential Disclosure Agreements (CDAs) pertaining to certain data and information shared pursuant to this MOU.  In accordance with applicable disclosure statutes and FDA regulations, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with MedStar, unless waiver is obtained from the owner of such information.  See 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63. 
  • Intellectual Property Guidelines:  “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of the MOU.  “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of the MOU.  Rights to inventions or intellectual property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the Parties.  Inventorship will be governed by U.S. law.  In the case of sole inventorship, ownership will be governed by the policies of the employer of the invention.  In the case of joint inventorship, ownership of inventions will be jointly owned.  Inventions made under a federal grant or contract will be subject to the Bayh-Dole Act. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party.
  • Conflict of Interest: Participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA.  This may require participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the HHS/FDA requirements.  If at any time prior to or during the performance of the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA official listed on the MOU so that the necessary action can be undertaken.  A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it.  Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
  • Patient Privacy Act: The Parties agree that any use or disclosure of protected health information (“PHI”) will be consistent with the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the privacy regulations in 45 CFR Parts 160 and 164 (the “HIPAA Regulations”), and other applicable federal and state laws and regulations.  

VI. Resource Obligations: 

This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and MedStar.  It does not create binding, enforceable obligations against any Party.  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 or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and MedStar operate.

VII. Liaison Officers:

A. For MedStar:

Rollin J. (Terry) Fairbanks, MD, MS FACEP
National Center for Human Factors Engineering in Healthcare
110 Irving St., NW, Suite NA 1177
Washington, DC 20010

B. For the FDA, the Center for Devices and Radiological Health is the lead center: 
Joel Myklebust, Ph.D.
Deputy Director
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903

Susan K. Meadows, MS, CHFP
Project Officer
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903

VIII. Term, Termination, and Modification:

This agreement, when accepted by all participating parties, will have an effective period of performance from the date of the latest signature for five (5) years 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 party.
IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed.  This MOU may be executed in counterparts and each counterpart shall be deemed an original.



Signed by: Mark Smith, MD
Director MedStar Institute for Innovation  Director
Date:October 11, 2011 


Signed by:Jeffrey Shuren, MD, JD
Center for Devices and Radiological Health
Date:October 20, 2011