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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.
Advising global pharmaceutical companies on HIPAA and state privacy issues relating to pharmaceutical marketing programs.
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.
Advised employer health plans on HIPAA breach notification requirements relating to breaches of protected health information held by the plans.
Advising a multinational pharmaceutical company on state privacy issues relating to a vaccine outreach program.
Represent an ad hoc consortium of U.S. 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.
On behalf of a major consumer products company, developed a HIPAA training module for the company’s health plan.
Advised major corporations on HIPAA compliance issues relating to their employer health plans.
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 another large pharmaceutical company in dealing with privacy issues resulting from the migration of patient data from a clinical study to a web based platform.
Assisted several large pharmaceutical companies with a variety of privacy issues relating to clinical trials, further use of data and pharmacovigilance reporting.
Advised a multinational biopharmaceutical company operating in China on privacy and property ownership issues related to the collection and sharing of biological samples in clinical trials.
April 3, 2017, Inside Privacy
The beginning of 2017 has brought a number of HIPAA enforcement actions involving covered entities. These enforcement actions indicate that HHS is continuing recent efforts to step up HIPAA enforcement and levy significant penalties for non-compliance. In January, HHS announced that it had reached a $475,000 settlement with a large health care network for ...
March 30, 2017, Business Forums International Ltd.
January 14, 2017, Inside Privacy
By Christopher Hanson On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.” In a separate post, we reported on the January 22, 2016 draft version of this guidance document. The final guidance provides FDA’s recommendations on a risk-based framework for medical device ...
December 23, 2016, Inside Privacy
A new post over on Covington’s eHealth blog discusses HIPAA-related provisions in the Twenty-First Century Cures Act, signed by President Obama on December 13. These provisions direct HHS to consider HIPAA’s effects on mental health treatment and the availability of health data for research purposes. Read the full post here.… Continue Reading
December 15, 2016, CCT News
Daniel Cooper is quoted by CCT News in an article regarding the use of wearable technology in the workplace. According to Cooper, the use of wearable devices is a good way, especially for insurers. However, the wearers’ privacy must be taken care of as well as their legitimate treatment concerns.
December 5, 2016, Inside Privacy
On December 1, 2016, the Commission on Enhancing National Cybersecurity released its Report on Securing and Growing the Digital Economy. In its Report, the Commission, established in February 2016 by President Obama, provided detailed short- and long-term recommendations to strengthen cybersecurity in the public and private sectors. The Commission took a ...
November 21, 2016, Financial Times
Daniel Cooper is quoted in a Financial Times article regarding wearable technology in the workplace. According to Cooper, not everyone will welcome sharing intimate personal information with the boss, however. “Wearable devices could be a good way for insurers to get the data . . . but it’s essential to address wearers’ privacy and fair treatment concerns and ...
September 13, 2016, Inside Privacy
The FTC has become the most recent regulator to take a closer look at ransomware and its impact on consumers. During the FTC’s September 7, 2016, Fall Technology Series on Ransomware, Chairwoman Edith Ramirez announced that the FTC will soon release guidance to businesses on how to protect against ransomware. Ransomware is a malicious software … Continue Reading
August 16, 2016, Inside Privacy
The EU-U.S. Privacy Shield’s recent introduction has created an efficient mechanism to ensure that trans-Atlantic personal data flows are lawful. With that in place, attention is now turning back to restrictions within the EU, particularly around hosting data in cloud computing services. European healthcare is particularly affected by such restrictions. This ...
August 11, 2016, Inside Privacy
A new post on the Covington eHealth blog reports that the UK government is running a consultation around NHS patient data security standards and a new legal framework for secondary uses (e.g. research) of patient data. To find out more about the proposals and the consultation, please click here.… Continue Reading
July 28, 2016, Inside Privacy
Today we published a post on the Covington eHealth blog regarding a recent report by the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC). The ONC report highlights “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by … ...
July 7, 2016, Inside Privacy
Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device. A new post on Covington’s Inside Medical Devices blog discusses the draft guidance and its implications for sharing patient information.… ...
A new post over on Covington’s eHealth blog discusses a recent enforcement action taken by the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) against Catholic Health Care Services, a business associate under HIPAA, arising out of a stolen iPhone. This recent enforcement action should put business associates … Continue ...
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