HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Thursday, May 24, 2012

Health Information, Privacy, and Innovation: Some Opening Questions

I’ll be speaking on privacy and fair data practices at an upcoming conference.  Health information law is a very exciting field.  Lawyers, doctors, and start-ups are re-thinking health care as an information industry.     The relationships between privacy, “big data,” and trade secrecy will bear a great deal of attention in coming years.

Software-based automation has raised living standards dramatically.  It makes factories more efficient, renders vast amounts of information accessible, and daily improves quality of life in barely noticed ways.  To realize these types of advances in health care, government and NGOs have begun to catalyze better data collection, retention, and analysis.  Life sciences companies need to report more data on drugs and devices. Hospitals and doctors are incentivized to use electronic health records via stimulus funding and rulemaking based on the HITECH Act’s meaningful use and certification requirements. 

All these development raise many questions, which I try to address in my seminar, Health Information, Privacy, and Innovation.  If any of our readers is interested in a syllabus, I'd be happy to send one.  Topics for the class are posed below: 

How will traditional intellectual property laws interact with initiatives to make health care more of an information industry?  Will the increasing need for cooperation and sharing of information alter the landscape of trade secrecy and other IP protections that have often siloed health data?  Will providers find alternative funding sources for the collection, retention, and analysis of data, as some traditional IP protections appear increasingly outdated in a world of “big data” and market-driven transparency?

Medical privacy law has focused on assuring the privacy, security, and accuracy of medical data. The post-ACA landscape will include more concern about balancing privacy, innovation, access, and cost-control.  Advanced information technology has raised a number of new questions.  Beyond HIPAA and HITECH regulation, consumer protection law plays an important role in these fields.  (For example, the FTC recently required firms that “score” the health status of individuals based on their pharmacy records to disclose these records to scored individuals.)

Patients are opting to personalize their health records with the help of cloud computing firms; what law governs this digital migration? There is increasing concern about the role of “incidental findings” in medical research and practice; how will regulators and professional groups address them?   When employers demand access to employee health records, in what ways can they use them to profile the employee?

We also need to examine the legal aspects of data portability, integrity, and accuracy.  When two health records conflict, which takes priority?  What is “meaningful use” of an electronic health records system, and how will regulators and vendors assure interoperability between systems?  The course will also cover innovators’ efforts to protect their health data systems using contracts, technology, trade secrecy, patents, and copyright, and “improvers’” efforts to circumvent those legal and technological barriers to openness.

Finally, what are pharmaceutical companies’ past and present strategies regarding the disclosure of their research, including non-publication of adverse results and ghostwriting of positive outcomes? Will a “reproducible research” movement, popular in the hard sciences, reach pharmaceutical firms?  Insurer data will also be a target of reformers (including trade-secret protection of prices paid to hospitals, conflicts over the interpretation of disclosure requirements in the ACA, and state regulation of insurer-run doctor-rating sites).   Quality improvement and pilot programs will need good provider and insurer data–how we will ensure they have them?


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