Increasing innovation in medical products is a policy priority. A first step to understanding changes in the level of innovation is to determine how to measure the baseline of innovation. Existing research employs a variety of measurement methods–scientific, therapeutic, and economic measures–to study trends in medical product (e.g., drugs, biologics, devices) innovation.
Office of Science and Data Policy (SDP)
The Office of Science and Data Policy is the departmental focal point for policy research, analysis, evaluation, and coordination of department-wide public health science policy and data policy activities and issues. The Office provides authoritative advice and analytical support to the ASPE and departmental leadership on public health science policy and data policy issues and initiatives, coordinates science and data policy issues of interagency scope within HHS, and manages interagency initiatives in science policy and data policy. The Office works closely with staff from across the Department on strategic plan development and implementation efforts. The Offices also carries out a program of policy research, analysis, evaluation, and data development in these issues.
The Office of Science and Data Policy includes several components:
- Division of Science and Public Health Policy
- Division of Evidence, Evaluation and Data Policy
- Division of Strategic Planning
Topic Areas:
- HHS Data Council
- Regulatory Impact Analysis
- Strategic Planning
- Information Quality Guidelines
- Prevention and wellness
- Public health systems and functions
- Food safety and nutrition
- Drugs and devices
- Tobacco control and prevention
- Biomedical research and development
- Economic analysis
- Emergency preparedness, response, and recovery
- Data and statistical policy
- Health disparities and vulnerable populations
- Health information technology
- Microsimulation
- Privacy policy
Reports
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Understanding the Role of Patient Advocacy Organizations in Funding Medical Product Research and Development
Patient advocacy organizations (PAOs) play a key role in medical product development. Many PAOs raise money to fund medical product development activities – such as basic science research, preclinical research, and clinical trials - for their condition of focus, whereas others fund or develop resources such as biobanks or patient registries to support the research community.
Report
U.S. Biosimilar Market Entry Challenges and Facilitating Factors
There is ongoing interest in understanding ways to reduce drug prices and improve patient access to prescription drugs in the U.S. The estimated savings to the U.S. healthcare system from the use of biosimilars are significant.
Report
2026 HHS Evaluation Plan
The Fiscal Year (FY) HHS 2026 Evaluation plan includes four (4) evaluations reflecting evidence-building activities in different Operating and Staff Divisions across the U.S. Department of Health and Human Services (HHS). The selected evaluations highlight activities that will generate actionable evidence in FY 2026 on priority topics.
ASPE Issue Brief
Use of Participant Compensation in U.S. Clinical Research Studies
Providing compensation to clinical research participants to offset the costs associated with participation is often suggested as a way to improve recruitment and retention. However, relatively little is known about the landscape of compensation in clinical research.
ASPE Issue Brief
Competition in the U.S. Therapeutic Biologics Market
Spending on biologics—large, complex molecules made from a living source—has been increasing over time and now represents nearly half of all U.S. prescription drug spending. Biosimilar competition for biologics is limited.
ASPE Issue Brief
Empowering Patients to Participate in Clinical Trials
Increasing patient engagement in clinical trials offers opportunities to improve enrollment and retention in clinical trials, helping ensure interventions can be evaluated effectively and that clinical research dollars are used efficiently.
ASPE Data Point
HHS Standard Values for Regulatory Analysis
The U.S. Department of Health and Human Services (HHS) analyzes the benefits, costs, and other impacts of significant proposed and final rulemakings, consistent with the requirements of several executive orders and statutes. HHS develops these analyses according to technical guidance published by the U.S.
ASPE Issue Brief
Understanding the Impact and Costs Associated with Medical Device Shortages During the COVID-19 Pandemic on Providers, Health Systems, Patients, and Manufacturers
We conducted a landscape analysis to understand the characteristics, impacts, and costs associated with medical device shortages during the COVID-19 pandemic in the U.S. Among health systems, nursing homes and rural hospitals were the most impacted by medical device shortages due to high demand and supply transportation issues.
ASPE Issue Brief
Long COVID among Essential Workers, Non-Essential Workers, and Not Working Persons in the United States, 2022-2023
The Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report examining trends in prevalence of Long COVID among different types of workers and among individuals who were not working. Workers in different occupations face different risks of COVID infection, and, potentially, Long COVID, depending on the nature of their work.