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Real-World Data: Policy Issues Regarding their Access and Use.

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Real-world data (RWD) access in the US is hindered by restrictive policies, potentially leading to underinvestment. Standardized misuse metrics could improve sharing of public RWD assets.

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Area of Science:

  • Health economics
  • Big Data in healthcare
  • Health policy analysis

Background:

  • Real-world data (RWD) is increasingly vital in healthcare, transitioning into the Big Data domain.
  • Current US policy environment's impact on RWD goals requires evaluation.
  • Discussions covered RWD availability, usefulness, public vs. private development, access bias, and quality assessment.

Purpose of the Study:

  • To assess the US policy environment's effectiveness in advancing RWD goals.
  • To identify improvements for RWD availability and accessibility.
  • To explore the balance between data access and potential misuse concerns.

Main Methods:

  • Convened a panel of health economists to discuss RWD policy.
  • Analyzed the current US landscape of RWD availability and usefulness.
  • Examined issues of RWD access bias and quality assessment principles.

Main Results:

  • A business case is often needed to incentivize RWD asset investment.
  • Access restrictions on public RWD assets may have caused underinvestment due to a lack of market.
  • Empirical evidence of for-profit misuse of public RWD is weak, yet restrictions persist.

Conclusions:

  • Current access restrictions on public RWD may hinder market development and investment.
  • Limited evidence supports strict access restrictions based on misuse fears.
  • Developing standardized metrics to flag RWD misuse could facilitate greater sharing of public RWD assets.