NPC Comments on the Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance
January 10, 2020
Principal Deputy Director Lawrence Tabak
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Dear Director Tabak,
Thank you for the opportunity to comment on the Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance. The National Pharmaceutical Council (NPC) shares the NIH’s goals of promoting effective and efficient data management and ensuring research results and accomplishments are shared with the public.
NPC is a health policy research organization dedicated to the advancement of good evidence and science and to fostering an environment in the United States that supports medical innovation. NPC is supported by the major U.S. research-based biopharmaceutical companies. We focus on research development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients. Our research helps inform important health care policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.
As the National Institutes of Health (NIH) finalizes guidance on data sharing, we encourage the agency to ensure that publicly funded research results and data are available for research purposes. The NIH should build on existing policies, including those established under the OPEN Government Data Act and the Health Insurance Portability and Accountability Act, ensuring that the information needed to conduct productive research is accessible, but personally identifiable health information is not publicly available. Health data from federal agencies and publicly-funded research is key to helping stakeholders accomplish many of our nation’s most ambitious health goals. Promoting transparency and consistency in data sharing policies can lead to increased public accountability, promotion of research rigor, and an increase in the generalizability of knowledge gained from such data,[1] ultimately creating better outcomes for public health broadly while still ensuring personal health information remains confidential.
Further, data access plays a vital role in supporting consumer decision-making and improving overall population health. For example, NIH efforts such as the All of Us Research Program hold great promise to accelerate personalized medicine, understand disease progression, and improve health. Developing comprehensive and accessible data policies will be key to ensuring All of Us core values are maintained, including transparency and data available for research purposes.[2] In addition, increasing the availability of research-identifiable files from both past and current research efforts can help further our understanding of precision medicine.[3] In an aligned, high-functioning health care system, everyone should be able to benefit from effective use of this and other data in order to improve quality and efficiency across the health care and public health landscapes of this country.
Federal and state agencies commonly release data at the aggregate health level, often called “public use files” or PUFs. While valuable for many research purposes, these files limit the data elements available or do not link to other files. For many research questions, data needs to be 1) available at the individual, rather than aggregate level, 2) longitudinal to distinguish patterns of care, 3) include dates of diagnoses, treatments and outcomes to accurately describe the order of events, 4) encompass fine-grained geographic detail to assess environmental or socioeconomic factors that may affect health outcomes, and 5) linkable to other data files such as provider characteristics, lab or genetic information, etc.[4]
To balance these research needs while maintaining individual privacy and confidentiality, many groups have addressed the policy dilemma using two approaches. First, other federal agencies have developed limited data sets (LDS) versions of files which limit the geographical information or small cell information. The NIH/National Cancer Institute Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked Database is an example of an LDS. Second, other data sets are available only to researchers at governmental agencies or researchers in academic and nonprofit organizations. The NIH National Institute on Aging Health and Retirement Study (HRS)-linked to Medicare enrollment claims is an example of a dataset limited by research affiliation.
Deep scientific and analytic expertise resides within organizations that are often excluded from access to publicly funded data. Many of these organizations already safely hold and analyze data collected through the delivery of health care operations. Ultimately, any standard that bars access to important data is detrimental to the larger goals of our healthcare system and the evolution of that system. Expanding access to federal and publicly funded data to all researchers will dramatically increase the bandwidth for research, leading to increased quality of care, system efficiency, and patient satisfaction.
All researchers, no matter their affiliation, should be granted similar access to publicly-funded data. Financial benefit and profit status of an organization should not overlay the criteria by which access to data or a research proposal are evaluated. NIH data sets and funded data such as the SEER and HRS linked databases are valuable tools for researchers from all organizations and it will be important to ensure that future data, including that information available in the All of Us Workbench and Hub,[5] are accessible and provide data that go beyond just summary information. The quality and efficiency of all physician groups, health plans, hospital systems, suppliers, and manufacturers can be enhanced using data. Therefore, the quality of research and its potential to improve health should instead be the standard. Placing a greater emphasis on research quality and intent, rather than simply the investigator’s affiliation could create greater opportunities while protecting confidential patient information.[6]
Overall, NPC encourages NIH to ensure that publicly funded research is available to all interested and qualified researchers. Consistent and straight-forward policies on data management throughout the government has the potential to enhance research and promote more innovation across this country’s health care system. We thank you for consideration of our comments and would be happy to discuss these ideas further.
Sincerely,
Jennifer S. Graff, PharmD
Vice President, Comparative Effectiveness Research
National Pharmaceutical Council
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[1] Doshi, JA, Hendrick, F, Graff, J, and Stuart, B. Data, Data Everywhere, But Access Remains a Big Issue for Researchers: A Review of Access Policies for Publicly-Funded Patient-level Health Care Data in the United States. eGEMS (Generating Evidence & Methods to improve patient outcomes), 2016; 4(2).
[2] National Institutes of Health All of Us Research Program “Core Values.” https://allofus.nih.gov/about/core-values. Accessed January 7, 2020.
[3] Doshi, JA, Hendrick, F, Graff, J, and Stuart, B. Data, Data Everywhere, But Access Remains a Big Issue for Researchers: A Review of Access Policies for Publicly-Funded Patient-level Health Care Data in the United States. eGEMS (Generating Evidence & Methods to improve patient outcomes), 2016; 4(2).
[4] Ibid.
[5] National Institutes of Health All of Us Research Program. “Workbench.” https://www.researchallofus.org/workbench/. Accessed January 8, 2020.
[6] Doshi, JA, Hendrick, F, Graff, J, and Stuart, B. Data, Data Everywhere, But Access Remains a Big Issue for Researchers: A Review of Access Policies for Publicly-Funded Patient-level Health Care Data in the United States. eGEMS (Generating Evidence & Methods to improve patient outcomes), 2016; 4(2).