Shifting Institutional Roles in Biomedical Innovation in a Learning Healthcare System

Privacy and Security and Innovation and Economic Growth

Article Snapshot


Rebecca S. Eisenberg


Journal of Institutional Economics, 2018 (forthcoming)


In future, health care outcomes will be guided by a learning healthcare system, which uses data from patients to evaluate treatments. Some data derived in clinical settings might be of low quality. The FDA now evaluates more treatments using data collected after the treatment begins to be used.

Policy Relevance

Patient data could help reduce waste and improve patient outcomes. Insurers will play a key role in developing treatments.

Main Points

  • In a learning healthcare system, data from past treatments and patient outcomes is used continuously to improve care; obstacles to the creation of this system include limits on the interoperability of health care records, and the difficulty of making sense of the data.
  • Traditionally, data was derived from premarket testing by firms that develop medical products; a learning healthcare system uses data from many sources, inviting many actors and institutions to ask and answer key research questions.
  • Insurers will play a larger role in research; a learning healthcare system will blur the distinctions between experimental care (which insurers do not cover) and conventional care.
  • Evidence-based medicine (EBM) was intended to improve patient outcomes by standardizing medical care using available evidence, but when the best data available was of low quality, EBM lead to questionable practices.
  • The quality of data generated in clinical settings might be low; even large studies include measures to control bias, which are missing from clinical settings.
  • The FDA has shifted away from reliance on pre-market testing towards a system of accelerated approval followed by ongoing data collection after the product has begun clinical use; some charge that patients are exposed to additional risk.
  • Over time, changes to Medicare rules required insurers to help pay for developing treatments and to enable patients to join clinical trials.
  • Insurers now bear a larger share of the costs of developing treatments, but are concerned about rising costs; however, because insurers have access to such large amounts of data, insurers can improve health outcomes and greatly reduce waste.


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