IEEE Standards and Projects Aim to Set a Framework for Broad and Affordable Use of Blockchain in Healthcare
Imagine that a flu vaccine shortage arises in the middle of a deadly flu season. There are likely unused doses sitting in hospital basements or doctors’ office supply rooms across the country. But because there is not a single, shared, and secure repository for the flu vaccine inventory, medical professionals cannot quickly locate those doses to get them into the arms of unvaccinated people.
However, by using blockchain technology for supply chain in healthcare and other situations, where product provenance and inventory transparency and tracking are crucial, the industry can work as a cohesive entity to solve some of the biggest healthcare issues impacting patients.
What is Blockchain Technology?
Blockchain, as a type of Distributed Ledger Technology (DLT), refers to a distributed database that resides on the Internet and is composed of records that are linked (or blocks that are chained together) in a manner that resists modification, hacking, or destruction. Blockchain’s characteristics make modifying past records impractical, which protects the integrity of the information it contains. By using blockchain for the vaccine supply chain, the inventory can be transparent without revealing too much data. It can even de-identify names of specific pharmacies or healthcare organizations.
Blockchain is decentralized, which means the data is not stored in a central location (such as the cloud) where it can potentially become compromised or hacked. However, the blockchain data does sit in a secure location. If a cybercriminal does manage to hack the chain, they will have very little information to steal—because the data (such as patient MRIs and outcomes, in the case of healthcare data) is not stored in the chain. Additionally, the blockchain technology automatically records when information has been breached and immediately replicates the data to reduce issues.
How Blockchain Enables Healthcare Data Provenance
Data holds the key to solving healthcare’s greatest challenges, such as providing basic care to remote corners of the world and curing deadly diseases. However, to make it a reality, we must design a solution to allow collaboration with professionals across the globe—in different locations and different environments. Additionally, privacy rules restrict how personal patient data can be shared, which makes the level of cooperation needed almost impossible with traditional technology.
However, blockchain provides the opportunity for data provenance— auditable transparency without sacrificing an individual’s identity or other personal information that patients wouldn’t want disclosed (commonly referred to as variable claims or credentials). Blockchain also enables patients the ability to manage their own health data, with full visibility of who accesses it and the right to consent to share information.
By using blockchain for pharmaceutical trials, the healthcare industry can collaborate in ways previously not possible. For example, the pharmaceutical company leading the trial creates a blockchain for the trial and builds a patient profile for each of the trial participants. Because of the structure and capabilities of blockchain, the patient’s identifiable data is completely anonymized making only the necessary credentials accessible to approved partners. Each participating patient in the trial has access to his/her data, and the pharmaceutical company owns the blockchain and decides how both patient and trial data would be governed.
From an industrial application, the clinical trial is auditable even with multiple partners working together. With all the verifying data in this decentralized chain, providers and researchers can see when a specific patient’s tests were sent to the lab and what results were accounted for. Because the pharmaceutical company must show that it obtained informed consent from the patient, the blockchain overcomes the previous issue with data provenance. Additionally, the blockchain provides visibility to the investigator in the trial, typically a contracted partner, who monitors for adverse reactions.
Throughout the trial, all the information and actions are tied back to the patient profile through the blockchain. When it’s time to submit data to the FDA, the pharmaceutical company has all the verifying information accessible from a single place and can easily show auditability and transparency throughout the process.
In traditional processes, it could take anywhere from three to six months or longer (depending on the size of the trial) for clinical trial auditors to obtain, validate, and verify the data of the trial before submitting for review. With blockchain, the amount of time and resources needed can be significantly reduced, accelerating the process for submission and review and thereby enabling new treatments to get to patients much sooner.
IEEE Standards for Blockchain in Healthcare
While blockchain has the potential to solve many key issues, the industry is currently struggling with the financial investment required to make it happen. Additionally, many healthcare or medical devices are not built to meet blockchain requirements, including security. Because healthcare is decentralized, blockchain only becomes an effective tool if all parties agree to participate in the use of blockchain.
The blockchain industry needs universal standards for the technical platform, system architecture, data format, application scenarios, and service capability to enable seamless and secure transfer of data across different environments. Currently, users across the world use different platforms, such as Open Hash, OpenChain, and Hyperledger, none of which communicate with each other.
As a result, a key issue standards must address is creating interoperability in a manner that’s affordable for healthcare organizations across the globe. In addition, as governments increasingly require specific protocols to protect patient’s health information, such as the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the EU’s General Data Protection Regulation (GDPR), standardization becomes even more critical for healthcare. The industry urgently needs a governance model that provides patient access and enables patient consent for use of their data.
To help address these challenges, IEEE Standards Association (IEEE SA) has created a collection of standards and projects to provide the framework needed for widespread and affordable use of blockchain in different industries including healthcare, including:
- IEEE P2418.6™ Standard for the Framework of Distributed Ledger Technology (DLT) for Use in Healthcare and the Life and Social Sciences: By addressing DLT tokens, smart contracts, transactions, assets, networks, off-chain data storage and access architectural patterns, the working group is creating a common framework for DLT use in healthcare. Additionally, IEEE P2418.6 addresses scalability, security, and privacy issues with blockchain usage in healthcare.
- IEEE P2418.1™ Standard for the Framework of Blockchain Use in Internet of Things (IoT): Because many of the uses of data for collaboration in healthcare involve IoT devices, such as remote monitoring and medical devices, this standard is also vital for widespread use of blockchain in healthcare. The goal of this standard is to create a standard for usage, implementation and interaction, while also addressing privacy and security concerns.
- IEEE P2933™ Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS – Trust, Identity, Privacy, Protection, Safety, Security: Based on TIPPSS principles and using blockchain technology, this standard project will establish a framework for Clinical IoT data and device validation and interoperability. This includes wearable clinical IoT and interoperability with healthcare systems including electronic health records (EHR), electronic medical records (EMR), other clinical IoT devices, in hospital devices, and future devices and connected healthcare systems.
Advancing Healthcare for All with Blockchain Technology
Beyond addressing existing challenges, the ultimate goal for blockchain technology is for patients to have what they have been wanting for decades—complete visibility and ownership of their own personal health data. In this world of patient-driven interoperability, blockchain technology can then incentivize data sharing between patients and researchers and potentially help save other patients’ lives around the world.
- Srikanth Chandrasekaran, IEEE SA Foundational Technologies Practice Lead
- Maria Palombini, IEEE SA Healthcare and Life Sciences Practice Lead
- John Greaves, Secretariat, IEEE P2418.6 Blockchain for Healthcare and Life Sciences Working Group