Blockchain Technology to Improve SUD Care (R43/R44 - Clinical Trial Optional)

Background

The U.S. healthcare ecosystem is complex, with multiple stakeholders and involves many intricate, and sensitive interactions. This intricacy leads to both data security and privacy challenges and operations inefficiencies. The problems that are common to the U.S. healthcare (e.g. misaligned incentives, lack of accountability and transparency, and multitude of stakeholders) are further exacerbated when it comes to the care of the patients suffering from the substance use disorders (SUD). SUD care space is excessively fragmented, suggesting that a system such as blockchain could be ideal for ensuring data integrity while decentralizing control.

Blockchain is a new way of storing data in a distributed ledger that allows various stakeholders to securely access the same information. Work describing a cryptographically secure chain of blocks started in the early 1990s and in 2008 the first blockchain was conceptualized and implemented the following year in the form of a cryptocurrency. Since then, uses of blockchain in industries outside of finance have emerged, including using blockchain technology to address the complex inefficiencies within health care ecosystem. This includes stakeholders ranging from insurance companies, to drug manufacturers, distributers, to clinical research organizations. Several programs have transitioned from ideation to implementation, in one case, even on a national level. In 2012, Estonia became the first country to nationalize blockchain within a healthcare system. Today, over 95% of the data generated by the county’s hospital and doctors is digitized, and blockchain technology is used for assuring the integrity of stored electronic medical records as well as systems access logs.

Within the US, several government agencies have recognized the potential use of blockchain in the healthcare ecosystem. Projects have ranged from ideation to implementation. In 2016, the Office on the National Coordinator for Health Information Technology (ONC) and the National Institute of Standards and Technology (NIST), announced the Challenge, "Use of Blockchain in Health IT and Health-Related Research". The Challenge solicited white papers on the topic Blockchain technology and the potential use in health IT to address privacy, security, and scalability challenges of managing electronic health records and resources. More recently, on December 10th, 2018, under the HHS Reimagine initiative, the Department of Health and Human Services received Authority to Operate a blockchain-powered acquisition system. This initiative was the first in the US federal government and the first for public procurement in the world to utilize blockchain technology.

Research Objectives:

The goal of this funding opportunity announcement (FOA) is to solicit the SBIR research applications for commercializable blockchain-based products to address specific inefficiencies within the SUD healthcare ecosystem. When appropriate, data should have a DOI assigned to it and block chain resources should be identified with a research resource identifiers (RRID). Some examples of studies to be conducted, include, but are not limited to:

Despite blockchain technology having the potential to streamline the exchange of health data and support improvements to the fragmented healthcare ecosystem, there are several technical and organizational challenges. This includes lack of successful blockchain models that demonstrate a clear value proposition to both the end user and the purchaser, data storage capacity, data ownership, volume requirements of healthcare (e.g. thousands of transactions per second), and uncertainty of how healthcare blockchain will confirm to new and old regulatory policies (e.g. Health Insurance Portability and Accountability “HIPAA” Act). To address this, applicants should consider working with both the end user and the purchaser as part of the Phase I application. At the end of Phase I activities, applicants should be able to demonstrate both technical and commercial feasibility.   

See Section VIII. Other Information for award authorities and regulations.

1. • Using blockchain in combination with artificial intelligence (AI) and machine learning to predict relapse;
   • “Blockchain-as-a-service (BAAS)” products for SUD;
   • Using blockchain to ensure the integrity of the medical records;
   • Using blockchain to ensure that researchers follow through on submitting data, especially negative data
   • Using blockchain for patient recruitment and engagement;
   • Empowering patients through the recording of consent decisions;
   • Tracking the prescription drugs in the pharmaceutical supply chain to the patient;
   • Validation of payments or claims
   • Streamlining the negotiations process between providers and health plans, reducing the provider’s administration costs
   • Value-based payment solutions
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