The Epidemiology Section and the Joint Policy Committee of the Societies of Epidemiology will sponsor a special session (#4097.1) scheduled for Tuesday, Nov. 10 from 10:30 a.m.-12:00 p.m.
Session Moderator: Daniel Wartenberg, PhD
Robert Wood Johnson Medical School, UMDNJ, Piscataway, N.J.
A few critics have proffered modest proposals to close epidemiology departments because epidemiology is no longer useful in the 21st century. They argue that we have found all that we can find using epidemiologic methods. Do you concur? This symposium examines the challenges and opportunities facing the field of epidemiology in the next 10 years. A panel representing federal, local and academic perspectives will highlight challenges and opportunities and propose strategies for the future. The symposium will invite audience participation.
Session Objectives: 1. Identify challenges and opportunities facing the field of epidemiology in the next 10 years 2. Discuss possible approaches to responding to the challenges facing epidemiology.
Speaker 1: Roberta Ness, MD, MPH
The University of Texas School of Public Health, Houston
The Impact of the Health Insurance Portability and Accountability Act Privacy Rule (HIPAA Privacy Rule) on health research in the United States.
Many scientists have raised concerns about the possible impact of HIPAA on the conduct of health research in the United States. To assess HIPAA’s impact, thirteen societies of epidemiology distributed a national Web-based survey. 1527 of eligible professionals anonymously answered questions. A total of 875 (67.8 percent) respondents reported that the HIPAA Privacy Rule has made research more difficult, many indicating that it added cost and time to study completion. A total of 684 (52.1 percent) respondents identified a “most affected” protocol. The respondents also indicated that the proportion of institutional review board applications in which the Privacy Rule had a negative influence on human subjects (participants) protection was significantly greater than the proportion in which it had a positive influence (P_.001).
In summary, this national survey of clinical scientists, only a quarter perceived that the rule has enhanced participants’ confidentiality and privacy, whereas the HIPAA Privacy Rule was perceived to have a substantial, negative influence on the conduct of human subjects health research, often adding uncertainty, cost, and delay. This presentation will discuss the results of the survey as well as the recent IOM committee's recommendations for HIPAA revisions.
Speaker 2: Kay Dickersin, PhD
Johns Hopkins Bloomberg School of Public Health, Baltimore
Initial National Priorities for Comparative Effectiveness Research
Clinical research provides health care providers with information on the natural history of disease, clinical presentations of disease, and diagnostic and treatment options. Consumers, patients, and caregivers also require this information to decide how to evaluate and treat their conditions. All too often, the information necessary to inform these medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness. This uncertainty contributes to great variability in managing clinical problems, with costs and outcomes differing markedly across the country.
Comparative effectiveness research (CER) is a way to identify what works for which patients under what circumstances. Congress, in the American Recovery and Reinvestment Act (ARRA) of 2009, appropriated $1.1 billion to jump-start the nation’s efforts to accelerate CER. In ARRA, the Institute of Medicine (IOM) was asked to recommend national priorities for research questions to be addressed by CER and supported by ARRA funds. The IOM committee identified three report objectives: 1) establish a working definition of CER, 2) develop a priority list of research topics to be undertaken with ARRA funding using broad stakeholder input, and 3) identify the necessary requirements to support a robust and sustainable CER enterprise.
This presentation will summarize the IOM Report and discuss its implications.
Speaker 3: Judith Racoosin, MD, MPH
US Food and Drug Administration, Rockville, Md.
The Sentinel Initiative: A National Electronic System for Monitoring Product Safety
In May 2008, the Secretary of Health and Human Services and the FDA Commissioner announced the Sentinel Initiative. The Sentinel Initiative is a long-term effort by the Food and Drug Administration to create a national electronic system for monitoring product safety. The Sentinel Initiative is intended to augment the Agency’s existing postmarket (primarily passive) safety surveillance systems and to actively gather information about the postmarket safety and performance of its regulated products. As currently envisioned, the Sentinel Initiative will enable the Agency to utilize multiple existing automated healthcare data sources (e.g. electronic health record systems, administrative claims databases, registries, or others) to evaluate safety issues occurring in marketed products. The data sources will continue to be managed by their owners, and only data from organizations who agree to participate in this system will be included. Questions would be sent to relevant participating data sources who would evaluate their data in accordance with existing privacy and security safeguards, and send summary results for Agency review. Two pilot programs will be getting underway in the near future, MiniSentinel I and MiniSentinel II, utilizing private data sources and federal data sources, respectively.