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Covington’s health information privacy lawyers are at the center of the debate regarding the privacy of medical records and other individually identifiable health information. We have developed extensive expertise on matters of health information privacy, working on these issues from the perspective both of affected entities and government regulators. We serve a broad client base of healthcare providers, pharmaceutical companies, benefit managers, group health plans, clinical laboratories, medical equipment manufacturers, and others whose businesses involve the handling of personal health information.

We routinely counsel clients regarding compliance with the privacy standards promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Clinical and Economic Health (HITECH) Act. We have assisted in our clients’ efforts to obtain amendments to, or clarifications of, these regulations. We also counsel our clients on state laws affecting the privacy of health information, such as genetic information and pharmacy records, and we regularly provide advice on the interaction between state law and the federal regulations governing the privacy of health information.

We often assist clients in the United States and Europe engaging in clinical trials and post-marketing research activities and have been involved in preparing informed consent forms, investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements and service provider agreements. We also assist companies in the healthcare industry with privacy issues relating to websites and live webcasts. Additionally, we have performed due diligence regarding healthcare privacy issues on behalf of venture capitalists and other entities interested in acquiring or investing in healthcare companies.

Our London- and Brussels-based lawyers have acquired unparalleled expertise in the unique privacy issues facing the pharmaceutical industry in Europe. We have been called upon to advise on the national rules in several European jurisdictions relating to the use of “biobanks” and research databases, privacy issues resulting from mandatory pharmacovigilance and adverse event reporting, key-coding of data, and the “further use” of data collected during clinical trials.

In Asia, we have assisted pharmaceutical companies operating in China with unique privacy issues, including advising privacy and property ownership issues related to the collection and sharing of biological samples in clinical trials.