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Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems.

There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional societies, to name a few– presents challenges that require careful planning and implementation. While regulators have recently taken significant steps to reconcile the differences among these laws and provide a path forward for harnessing the potential of big data, some specific requirements within these individual regulations continue to present challenges.

It is critical for academic medical centers and teaching hospitals, which stand at the intersection of government-funded research and industry-sponsored research, and are also paving the way in partnerships with non-traditional health care players—to understand the evolving legal framework and business and compliance imperatives behind the quest for digital health information.

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McDermott Will & Emery is a premier international law firm with a diversified business practice. Numbering more than 1,100 lawyers, we have offices in Boston, Brussels, Chicago, Düsseldorf, Frankfurt, Houston,...

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Jiayan Chen, McDermott Will Emery Law Firm, Health Care attorney
Partner

    Jiayan Chen is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  She focuses her practice on counseling clients on a range of regulatory issues, including compliance and strategic considerations for data sharing and research initiatives, as well as on transactions relating to pharmaceutical and medical device companies.

    Jiayan’s regulatory practice includes advising clients on research compliance and data privacy and security laws, including the Common Rule, FDA good clinical practices, HIPAA, the Privacy Act of 1974, as well as similar state laws and regulations.  In that regard, Jiayan helps clients assess the range of legal, regulatory, and other strategic considerations attendant to the development of data sharing platforms and to data and biospecimen collection and repositories, including in the context of personalized medicine and future, unspecified use.  She also has experience preparing data privacy policies and programs and counseling clients on other various legal and compliance issues arising from the use and disclosure of protected health information.  Additionally, Jiayan’s work for life sciences clients includes advising on compliance with, and implementation of, the “Sunshine” provisions of the Patient Protection and Affordable Care Act.

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