Accelerating Research

Increasing Privacy Protection and Reducing Research Impediments

Challenge: In 2009, an Institute of Medicine report concluded that the HIPAA Privacy Rule does not adequately protect patient privacy and that it significantly impedes research, making critical information more difficult, more costly, and, in some cases, impossible to obtain.

Goal: Change the HIPAA Privacy Rule and related research and health data policies to strengthen patient privacy protection and accelerate cancer research through advocacy and education efforts.

Leadership: 

  • Robert C. Young, MD (RCY Medicine), Chair and Cost Paper Workgroup Chair
  • Tom Burish, PhD (University of Notre Dame), Position Paper Workgroup Chair
  • Victor Vogel, MD, MHS (Geisinger Medical Center), Advocacy Workgroup Chair

Focus of Effort:

  • Illustrate the barriers and burdens 
  • Offer concrete suggestions for changes 
  • Prepare for strong opposition by privacy advocates
  • Present the perspectives of health/disease researchers
  • Align support of patient advocates
  • Engage legislators / caucuses and regulators

Recent Progress:

  • Cost Study:  This sub-committee of researchers and economists determined that existing studies sufficiently illustrate the time, cost burden, and opportunity costs of HIPAA.  Rather than commission new research, the group has engaged a science writer to summarize existing research from the IOM report and other literature for use in the position statement.  The statement will be geared toward policymakers and regulators. The subcommittee will review the draft report in January 2011.
  • Indiana University (IU) received and NIH ARRA Grant to propose a detailed framework for exempting research from HIPAA in accordance with the primary IOM recommendation.  Alison Smith was appointed as a panel member representing C-Change to provide access to the broader cancer research and patient advocacy communities. Position Paper Sub-Group Chair Tom Burish, committee member Dennis Deapen, Donna Boswell (Hogan Lovells), and representatives from other advocacy and disease organizations participated in the first forum on behalf of C-Change.  Forum 2 of 3 was held in Washington, DC in December 2010.
  • Position Paper:  The IU Grant team is authoring a series of brief position papers.  The C-Change reviewed and provided comment on the draft IU paper. C-Change will develop additional position statements as necessary. 
  • Communication and Advocacy: C-Change is working collaboratively with the American Society of Clinical Oncology (ASCO), American Association of Cancer Research (AACR), and Infectious Disease Society of American (ISDA) on advocacy efforts.  Relationships with other disease research communities such as the HIV, mental health, and gastrointestinal disease groups are being pursued. Each organization is gathering vignettes illustrating the barriers imposed by HIPAA to the research process.  These vignettes will be used to develop a speaker’s kit for use in raising awareness and support among researchers and clinicians as well as policymakers and regulators.  The vignettes will also be provided to the IU grant team for possible integration in their position papers or final recommendations. Coalition members are considering thepossibility of holding hill briefings and visits to sensitize policymakers to the challenge, cultivate an issue champion, and prepare for more specific advocacy efforts.
  • Submitted public comments regarding Modification to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information and Technology for Economic and Clinical Health Act (“HITECH”) (9/13/10).
  • Hosted a special session at the C-Change Annual Meeting for the membership to meet with the Indiana University NIH ARRA Grant Primary Investigator to ensure cancer community input into their recommendations.
  • Submitted public comments to the Office of the National Coordinator for Health Information Technology regarding the President’s Council of Advisors on Science and Technology (PCAST) report, ‘‘Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward’’ (1/19/11).

Next Steps for 2011

  • Continue to gather vignettes regarding HIPAA barriers from the cancer community.
  • Continue to engage additional organizations through the review of public comments in response to recent HIPAA modifications related to research.
  • Complete & Disseminate HIPAA Cost Study Report.
  • Develop a position statement for exempting research from HIPAA and/or modifying existing regulations and guidance
  • Develop speaker’s kit of HIPAA issues including cost study highlights and anecdotes to raise awareness among research and clinical communities of the broadly felt impact of HIPAA across research types (clinical trials, information-based research, etc.) and diseases.
  • Host hill briefings with coalition members.
  • Define and pursue a communication and advocacy plan that utilizes the findings of the cost study, position paper, and Indiana University recommendations.

Workgroups

Cost Study Paper:  Robert C. Young, MD, Chair, Martin Brown, PhD, Stan Crosley, JD, Dennis Deapen, DrPH, David Meltzer, MD, PhD, Roberta Ness, MD, MPH, Scott Ramsey, MD, PhD, Richard Schilsky, MD, Deborah Schrag, MD, MPH

Position Paper: Tom Burish, PhD, Chair, Melissa Bianchi, JD, Donna Boswell, JD Suanna Bruinooge, Stan Crosley, JD, Dennis Deapen, DrPH, Sandra Horning, MD, Sharyl Nass, PhD, Mace Rothenberg, MD

Communication and Advocacy plan:  Victor Vogel, MD, MHS, Chair, Marianne Alciati, PhD, Melissa Bianchi, JD, Donna Boswell, JD, Jeff Allen, PhD, Pam Bradley, PhD, Adam Clark, PhD, Candi Wolff, JD Barbara Wood, Esq.

Advisory Committee
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