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, including:
- health care providers
- pharmaceutical manufacturers
- device manufacturers
- benefit managers
- group health plans
- clinical laboratories
- health information technology vendors
In the United States, we routinely counsel regarding compliance with the privacy and security standards promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information and Technology for Economic and Clinical Health (HITECH) Act. We also counsel our clients on state laws affecting the privacy of certain types of medical records, including genetic information and pharmacy records, and on issues relating to the interaction between state and federal privacy law.
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
- service provider agreements
We also advise health care industry clients regarding privacy issues relating to websites and other social media, marketing initiatives, and laws such as the Controlling the Assault of Non-Solicited Pornography And Marketing Act (“CAN-SPAM”). We frequently perform due diligence regarding healthcare privacy issues on behalf of venture capitalists and other entities interested in investing in health care companies and health information technology vendors. In addition, we have advised numerous clients in responding to breaches of protected health information.
Our London and Brussels-based lawyers have acquired unparalleled expertise in the unique privacy issues facing the pharmaceutical industry in Europe. We have advised 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
- the “further use” of data collected during clinical trials
Representative Matters
- We advise many global pharmaceutical companies 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, marketing activities, and EU Safe Harbor certification.
- We have assisted numerous global pharmaceutical companies in developing comprehensive privacy policies aligned with federal (HIPAA, HITECH, Food & Drug Administration, and National Institutes of Health) regulations, state and European law, and best practices.
- We 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.
- We 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.
Accolades
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2013)
- Life Sciences, Global-wide
- Life Sciences, Europe-wide
- Chambers USA (2013)
- Life Sciences, Nationwide
- Life Sciences, CA
- Chambers UK (2013)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Chambers Asia (2013)
- Life Sciences (International Firms), China
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Leading: Government Enforcement and Investigations, USA
- Highly Recommended: Life Sciences, Belgium
- LMG Life Sciences (2012)
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