Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss SG - New England Journal of Medicine
- Commentary & Opinion
- Regulation and Clinical Evidence
Summary:
The authors detail the HIPAA and HITECH Act pathways for sharing health data for post-approval drug safety research, assessing the usefulness and liability risks of each pathway and arguing for frameworks that enable robust pharmacoepidemiological research while protecting patient privacy.
VIEW SOURCE
Recent Work from PORTAL
How Congress Can Fix Expert Advisory Committees
Daval CJR, Kesselheim AS - STAT
- Commentary & Opinion
- Regulation and Clinical Evidence
International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway
Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy
- Research Publications
- Price, Value, and Access
- Regulation and Clinical Evidence
Politics and the Patient Encounter, in Dire Times
Avorn J - MedPage Today
- Commentary & Opinion
- Regulation and Clinical Evidence
Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital • Harvard Medical School
41 Avenue Louis Pasteur, Suite 0B17, Boston, MA 02115
©2026 Program On Regulation, Therapeutics, And Law (PORTAL). All rights reserved.