Transparency in Health and Health Care in the United States

Holly Fernandez Lynch Is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics at the University of Pennsylvania's Perelman School of Medicine. She focuses her scholarly research on issues at the intersection of law, bioethics, and health policy, in particular the ethics and regulation of research with human subjects and conflicts of conscience in health care. I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law and Faculty Director of Petrie-Flom Center for Health Law, Biotechnology & Bioethics at Harvard Law School. He is one of the world's leading experts on the intersection of bioethics and the law, as well as health law. He is the author of more than 110 articles in venues like the New England Journal of Medicine, JAMA, Nature, and the Harvard Law Review, and the author, editor, or co-editor of twelve books. Carmel Shachar is the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Carmel's scholarship focuses on law and health policy, in particular the regulation of access to care for vulnerable individuals, health care anti-discrimination law and policy, and the use of all-payer claims databases in health care research. Carmel is also a Lecturer at Law on Harvard Law School, where she co-teaches a course on Health Care Rights in the Twenty-First Century. Barbara J. Evans is the Mary Ann and Lawrence E. Faust Professor of Law, Professor of Electrical and Computer Engineering, and Director of the Center for Biotechnology and Law at the University of Houston. Her research interests include data privacy and access, regulation of emerging biotechnologies and machine-learning software, and genomic civil rights.

• Introduction Carmel Shachar, I. Glenn Cohen, Holly Fernandez Lynch and Barbara J. Evans; Part I. Transparency in Health and Health Care: Thematic Issues: Introduction Abigail R. Moncrieff; 1. Smashing into windows: 'the limits of consumer sovereignty in health care' Barry R. Furrow; 2. The interplay of privacy and transparency in health care: the HIPAA privacy rule as a case study Barbara J. Evans; 3. Transparency tradeoffs: priority-setting, scarcity, and health fairness Govind Persad; 4. Slightly hazy: transparency and the costs of too much information Oliver J. Kim; Part II. Transparency and Informed Consent: Introduction Luke Gelinas; 5. Transparency versus informed consent: the patient/consumer paradigms Craig J. Konnoth; 6. Transparency and financial conflicts: the uncertain case for sunshine Richard S. Saver; 7. Making religion transparent: the substance, process, and efficacy of disclosing religious restrictions on care Elizabeth Sepper; Part III. Transparency and Economics: Health Care Costs and Billing: Introduction Kristin M. Madison; 8. Transparency on prescription drug research expenditures: a lever for restraining pricing? Ameet Sarpatwari, Jerry Avorn and Aaron S. Kesselheim; 9. Is pharmaceutical price transparency an effective means to reduce high prices and wide variations? Marc A. Rodwin; 10. Price transparency: a contracts solution Wendy Netter Epstein; 11. Solving surprise medical bills Mark A. Hall; Part IV. Transparency and Innovation: Introduction Holly Fernandez Lynch; 12. Increasing the transparency of FDA review to enhance the innovation process Rachel E. Sachs and Thomas J. Hwang; 13. Transparency and clinical trial data sharing: legal and policy issues Barbara E. Bierer, Mark Barnes and Rebecca Li; 14. The European Medicines Agency's approach to transparency Stefano Marino and Spyridon Drosos; Part V. Transparency and Outcomes: Promoting Health and Safety: Introduction Gregory Curfman; 15. The role of transparency in promoting healthy behaviors: pros, cons, and perils of information sharing to foster personal responsibility in health care Anthony W. Orlando and Arnold J. Rosoff; 16. The role of transparency in patient safety improvement Michelle M. Mello, David M. Studdert, Brahmajee K. Nallamothu and Allen Kachalia; 17. Personal health records as a tool for transparency in health care Sharona Hoffman; 18. Nontransparency in electronic health record systems Jim Hawkins, Barbara J. Evans and Harlan M. Krumholz; 19. Transparency challenges in reproductive health care Dov Fox; Part VI. Challenges in Promoting and Measuring Transparency in Health Care: Introduction I. Glenn Cohen; 20. ERISA as a barrier for state health care transparency efforts Erin C. Fuse Brown and Jaime S. King; 21. Transparency and data sharing in clinical research and Big Pharma Jennifer E. Miller; 22. Promoting IRB transparency: about what, to whom, why, and how? Holly Fernandez Lynch; 23. Using disclosure to regulate PBMs: the dark side of transparency David A. Hyman and William E. Kovacic.