The Imperative for Modernizing Informed Consent

It’s hard to overstate the importance of informed consent. It’s a critical factor for improving data sharing, care coordination, operational efficiencies, outcomes and health equity – and it’s required not only in healthcare, but also social services, education, behavioral health, justice and other domains. Most pointedly, expediting consent levels the playing field by empowering everyone to make informed decisions about sharing their personal information. The processes for obtaining, revoking and managing consent are still highly siloed and often paper-based, however, and that is why Stewards of Change Institute has decided to sharply focus its activities in 2022 on bringing them into the 21st Century. Our recent national report, Modernizing Consent to Advance Health and Equity,” provides details and insights.

Pilot Project Partnerships. A primary way in which we’re driving progress is by developing a pioneering Consent Service Utility (see below) that will be implemented this year by “shovel ready” sites that have agreed to partner with SOCI. These pilot project sites include: the Integrated Care for Kids (InCK) program in the Bronx, NY, which is being funded by the federal Centers for Medicare and Medicaid Innovation to improve outcomes for children/families and to demonstrate the value of alternative payment models; Hennepin County, MN, which is concentrating mainly on the impact of homelessness on health; and several other jurisdictions that want to participate in various ways, including the New Jersey InCK program, San Diego (CA) County and the State of Colorado. The goals of these projects include to:

  • Demonstrate the CSU’s effectiveness for improving informed consent in ways that can be replicated and customized by jurisdictions and commercial entities across the US and globally.
  • Support jurisdictions seeking innovative ways to improve whole-person, integrated, coordinated care through use of their Medicaid funds and waiver authority.
  • Drive progress for remediating socioeconomic and racial disparities and improving health equity.

Consent Service Utility. The CSU is being developed by SOCI’s Project Unify as an open-source, open-API, standards-based solution for providing, managing and revoking permission to share private data across numerous domains. In practice, it will function as a sole “registry” for storing (or identifying the location of) all consents in a jurisdiction; for authorizing users; and for providing notification to authorized providers/users. The CSU will include a common user-interface that enables informed consent to be obtained in conformity with all applicable state and federal privacy laws, policies and codes. It will also include a configurable “back end” (rules engine) to ingest, filter and segment those applicable elements.

We refer to the CSU as a utility because its core elements and open-source technologies can be customized to meet unique local needs without recreating the product. Responses to the CSU concept have been very positive, with scores of subject-matter experts, technologists and government officials already engaging in its development and potential deployment in a variety of ways. Among them are: