NCPA - National Center for Policy Analysis

Regulating Genomic Research: Top-Down Or Bottom-Up?

July 30, 2015

The next frontier in information technology is genomic sequencing, which will create the biggest of big data resources by 2025. It has been 15 years since President Clinton announced the first sequencing of the human genome; and it is now clear that researchers' ability to free the unimaginable wealth of information locked inside our genomes is bumping up against constraints imposed largely by the federal government. This is the topic of an impressive white paper co-published by the Health IT Now Coalition and the Center for Data Innovation at the Information Technology & Innovation Foundation, according to senior fellow John R. Graham of the National Center for Policy Analysis.

This review summarizes the recommendations and suggests a possible way to push the boat out a little farther. The three recommendations are:

  • Improve interoperability and data sharing by strengthening federal requirements for health data and "bottom-up, patient-driven" reforms that give patients more control over sharing their health data.
  • Engage patients in the dialogue about genomic research.
  • Re-think privacy law, especially the Health Information Portability & Accountability Act (HIPAA) and the      Common Rule governing research on human subjects, especially the definition of "informed consent."

The white paper suggests Congress would increase federal requirements on regulated institutions and researchers. For my money, the "bottom-up" approach is more likely to succeed. Progress may be quicker if Congress allows states to take the lead. If the state were the locus of oversight, researchers, patients and other interested parties might update the regulatory apparatus faster than waiting for Congress to act.

The paper invites Congress to revisit the Common Rule and HIPAA, even suggesting a stretch goal of a universal consent form.

Source: John R. Graham, "Regulating Genomic Research: Top-Down Or Bottom-Up?" Forbes, July 27, 2015.


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