Nosowsky Rachel, Giordano Thomas J
Office of the Vice President and General Counsel, University of Michigan, Ann Arbor, Michigan 48109, USA.
Annu Rev Med. 2006;57:575-90. doi: 10.1146/annurev.med.57.121304.131257.
In the short time since it became effective for health care organizations, a privacy regulation issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has had a significant adverse impact on the conduct of clinical research in the United States, without a substantial corresponding increase in privacy protection for research participants. Some of the problems associated with HIPAA have been resolved through revisions since the regulation's initial promulgation in December 2000, and other problems can be addressed by better educating health care providers and researchers about its requirements and available alternatives for compliance; however, considerable structural challenges remain. These constitute substantial barriers to research and resulting medical advances. Additional revisions to HIPAA based on the principles and trade-offs reflected in the Common Rule-which responsibly balances an individual's interest in privacy protection with the public interest in gaining knowledge through biomedical research-can go a long way to remedying remaining flaws in the system.
自1996年《健康保险流通与责任法案》（HIPAA）下发布的隐私法规对医疗保健机构生效后的短时间内，它已对美国的临床研究开展产生了重大不利影响，而对研究参与者的隐私保护却没有相应大幅增加。自该法规于2000年12月首次颁布以来，通过修订已解决了一些与HIPAA相关的问题，其他问题可通过更好地向医疗保健提供者和研究人员宣传其要求以及可用的合规替代方案来解决；然而，重大的结构性挑战依然存在。这些构成了研究及由此产生的医学进步的重大障碍。基于《通用准则》所体现的原则和权衡对HIPAA进行进一步修订——《通用准则》负责任地平衡了个人对隐私保护的利益与通过生物医学研究获取知识的公共利益——对于弥补该系统中剩余的缺陷大有帮助。
