• PURPOSE: To assess the impact of the Health Insurance Portability and Accountability Act (HIPAA) on research in ophthalmology. • DESIGN: A personal perspective with a review of relevant publications. • METHODS: Review of experience at a single institution as it transitioned to enforcing HIPAA guidelines. • RESULTS: HIPAA has been costly to institutions and will continue to be so. At Johns Hopkins alone, nearly 26,000 employees have had to take HIPAA compliance training and pass examinations with an overall estimated cost of nearly $2 million in the first year. At the same time, complying with HIPAA regulations has increased institutional awareness of privacy issues. • CONCLUSIONS: HIPAA has added a layer of regulation to research that has increased the burden of researchers but is unlikely to prevent most research from taking place. Although there are clear benefits to the heightened awareness of the implications of research on study subjects' privacy, the costs of implementing HIPAA have been very high, and further refinements are likely necessary.
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