Covington’s health information privacy lawyers have played a key role in the debate over the privacy of medical records and other individually identifiable health information. 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 these clients regarding compliance with the privacy standards promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and 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.
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. Lawyers in our London and Brussels offices have acquired unparalleled expertise in the unique privacy issues facing the pharmaceutical industry in Europe.
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.
- Represented Wyeth in a consumer class action alleging that it violated various privacy rights granted by the California Constitution, the California Confidentiality of Medical Information Act, and common law through its participation in direct mailing programs run by various pharmacies.
- Assisted pharmaceutical companies in developing global comprehensive privacy policies aligned with federal (HIPAA, Food & Drug Administration, and National Institutes of Health), state and European law, and best practices.
- Conducted due diligence regarding a target company’s privacy and data security practices on behalf of a client seeking to acquire a healthcare information products company.
- 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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