Blockchain in Healthcare: Regulatory Themes

7 July 2020 (Last Updated July 7th, 2020 17:18)

Blockchain in Healthcare: Regulatory Themes

While blockchain is yet to take-off fully in the healthcare, it is regarded as one of the most disruptive technologies within the sector. It will build higher levels of transparency and trust across the healthcare ecosystem. From uncovering demographic trends to tracking the supply chain, blockchain has the potential to accelerate R&D, drive precision medicine, improve medical products quality, create more efficient care, and improve patient outcomes at a reasonable cost.

Listed below are the key regulatory themes impacting blockchain usage in the healthcare industry, as identified by GlobalData.

Lack of regulations related to blockchain in healthcare

Similar to any cutting-edge technology, the application of blockchain in healthcare lacks regulatory and formal guidance. Regulators across the world are expected to scrutinise these technologies in healthcare thoroughly in the next five years, with privacy and security being one of the main focus points.

Drug Supply Chain Security Act

The FDA’s Drug Supply Chain Security Act (DSCSA) is intended to increase regulatory oversight of counterfeit, stolen, contaminated, or otherwise harmful drugs. Some pilot projects under DSCSA test how blockchain can secure information sharing across healthcare enterprises. The goal is to develop an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the US. Participation reflects the diversity of the supply chain by including large and small entities from all industry sectors. For example, KPMG, IBM, Merck and Walmart have been chosen for a pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

Health Insurance Portability and Accountability Act and General Data Protection Regulation

In the US, the Health Insurance Portability and Accountability Act (HIPAA) provides data privacy and security provisions for safeguarding medical information. General Data Protection Regulation (GDPR) is a regulation law on data protection and privacy for all individual citizens of the EU and the European Economic Area (EEA). Both of these regulations provide a significant incentive for the adoption of blockchain-powered applications in healthcare.

Transparency and interoperability have been major barriers to EHR adoption and integration in the past few years, and blockchain technology might be the breakthrough that industry needs. In the blockchain community, there is a core idea that individuals have the right to master and sell all information related to their own digital identity. Some blockchain-based solutions further suggest that individuals can set a special numeric address for each health record, which is fully encrypted and cryptographically signed.

This is an edited extract from the Blockchain in Healthcare – Thematic Research report produced by GlobalData Thematic Research.