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.
Lawyers in our health information privacy practice serve a broad client base comprising healthcare providers, pharmaceutical companies, benefit managers, group health plans, clinical laboratories, medical equipment manufacturers, and others whose business involves the handling of personal health information. We routinely counsel these clients regarding compliance with the privacy standards promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 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 certain types of medical records, including genetic information and pharmacy records. In addition, we regularly provide advice on the interaction between state law and the federal regulations governing health information privacy.
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 regarding 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 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.
Representative Matters
- Advised pharmaceutical companies in the United States and Europe on data privacy issues, including questions relating to genetic testing programs and the development of genomics databases, the sourcing and handling of human tissue and biological samples for research purposes, patient outreach, and marketing activities.
- Assisted pharmaceutical companies in developing global comprehensive privacy policies aligned with federal (HIPAA, Food & Drug Administration, and National Institutes of Health) regulations, state and European law, and best practices.
- Represent an ad hoc consortium of US and European pharmaceutical and medical device companies concerned about data privacy issues in Europe, including the Eastern European Member States such as Hungary, Poland, and the Czech Republic.
- Advised a large pharmaceutical company in connection with litigation involving the alleged infringement of patient privacy by a pharmacy chain that collects personal information about prescription drug users.
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