What is it?
Though there has yet to be a breakthrough report or use-case for blockchain technology in healthcare, there are many potential ways that the blockchain could be implemented within the current healthcare structure. Any list will likely be incomplete, but these examples represent some of the published and available literature on blockchain implementations in health.
Health Information Exchange (HIE)
One major area that blockchains may be able to facilitate is the secure access to and communication of patient health records between individuals and institutions. There have been multiple white papers published on the topic, including groups from the Mayo Clinic [14] and MIT [15] who described a system for patient information exchange based on blockchain technology that would allow patient-controlled access to records across institutions using HL7 Fast Healthcare Interoperability Resources (FHIR), JSON, or other encoding system. In these models the actual health care data are not encoded in the blockchain but are merely references pointing to where the data reside, such as at institutions or in a “data lake” [16]. Similarly, a group out of China described an app called Healthcare Data Gateway (HGD) that allows patients to view and directly control rule-based access to their health records with a smart phone interface and authentication provided by a blockchain network [17]. These ideas support the concept of patient-owned medical data and would have the effect of decentralization of medical records in ways that are yet undetermined.
Health Research Integrity
Academic research is a major driver of advances in health care, but in the setting of limited funding and publication pressures on researchers’ significant concerns have been raised regarding research integrity [18]. Organizations such as ClinicalTrials.gov and others have been developed to help drive researchers to define endpoints and analysis prior to conducting clinical trials and other studies. As it represents an immutable, verifiable record of events and transactions, the blockchain has been proposed as a potential decentralized resource for helping to ensure biomedical research integrity. Benjamin Carlisle [19], followed by several researchers from the UK[20], proposed in 2014 that researchers could use the blockchain to record pre-specified aspects of their projects, including the study design, analysis plan, and data structure, among others, which could later be verified by consumers of the literature to decrease bias that may be introduced in post-hoc analysis[21]. The blockchain also offers the potential ability to verify the integrity of actual research data and analysis by outside observers, even if the data themselves are not made publicly available. These types of implementations may lead to improvements in both the integrity of biomedical research as well as bolster public trust in medical research.
Personal Health Records
This concept dovetails with the idea of HIE using the blockchain but focuses more on the secure maintenance of a personal health record (PHR) by patients. No production PHR has been released based on this technology, but concepts such as MedVault [22] use alternative blockchains such as Colu to store patient data directly on the blockchain. Others such as eHealthWallet have also developed prototype PHRs based on the blockchain. Patients could then share or authorize doctors and other health entities to access and modify their data.
Most of the proposals leverage blockchain’s ability to maintain an immutable record to place control of patient’s health record into their hand by allowing them to grant and revoke access to their medical records according to their preference [23][24].
In a traditional system, patient’s health record is kept and maintained by a health care organization (e.g. hospital, clinic, etc.). Information can be freely shared between the organization and a Regional Health Information Organization (RHIO) or another organization that has a business agreement with the originating institution. If there is no business agreement between the institutions, one-off requests can be made, but this will take time and delay care.
As Meaningful Use Stage 3 is being implemented at health care organizations, there has been a push to create patient-facing application programming interfaces (APIs) that allow patient to directly retrieve their record from the institution and share it with the provider as needed.
A blockchain-enabled smart contracts controlled by the patient can be used to authorize direct sharing of medical record between institutions. Patient can specify the subset of the record to be shared or set an expiration date on the authorization.
Gordon et al. suggested five features of block chain that allow for successful patient-driven interoperability [25]:
Digital access rules: The blockchain-enabled digital access rule is centralized, which makes it accessible by multiple institutions, while facilitating editing of the rules by the patient at any moment via a smart phone-based or web-based application
Data aggregation: Patient could also aggregate their data (or metadata) across institutions to a blockchain or another secured location using the digital access rule, thus creating a complete record of their health.
Data liquidity: Because the change in digital access rules will take effect as soon as the patient (or legal representative) approves it, data can be share rapidly to the requesting institution, allowing access to time-sensitive information such as allergies, “code status,” etc.
Patient identity: Even though there is no national patient identifier, institutions can use the blockchain-assigned individual’s public key and match it with their local identifier to start sharing data across systems.
Data immutability: Since all changes made to the blockchain is recorded and immutable, the risk of loss is minimized, and the record can be audited at any time.
There are several limitations of the current state of technologies for blockchain-based personal health records:
The first concern with blockchain is its inability to handle the transaction volume of clinical data. Blockchain is great at keeping a record of changes to a small amount of data (such as account balance, owner’s identity, etc.). However, it is not economically practical to store a large amount of data on the blockchain due to cost associated with creating a very large ledger to store this information and to perform proof-of-work on this ledger.
Proposed solutions include:
Validate data using a different approach to consensus such as proof-of-stake.
Store a summary of, instead of a complete clinical report.
Patient’s data can be stored on a permissioned (private) regional blockchains that are built to handle large transaction volumes without time-intensive validation.
A second limitation of blockchain is the lack of privacy and security. Even though the identifier on the blockchain is the cryptographically generated public key, this is only pseudonymous, as patient can still be identified by matching for other basic demographic information, and once the public key has been linked to the patient, their activity on the blockchain can be tracked. A few solutions to this problem have been proposed:
Use permissioned (member-only) blockchain to avoid public exposure.
Basic demographic information stored on a block chain can also be encrypted to prevent access.
Store sensitive data off-chain, with on-chain data focusing on granting permission to access requested data using pointers and metadata. This would also allow patients to assign different access rule for different users of their data.
Since the focus of many blockchain-based projects is on patient-controlled health care data, it necessitates more patient participation than the traditional, institution-based paradigm. They must be able to assign certain permissions for different institutions that request access.
Having a patient-friendly “app” to manage public keys and permissions will become very important to get more buy-in from patients.
Patient will also need to keep track of their password to gain access to their private key to make changes to the block chain. There will need to be a mechanism for recovering lost password when this occurs.
The largest barrier to widespread adoption of blockchain in healthcare deals with the issue of incentives. Meaningful Use stage 3 requires implementation of patient-facing API, but this does not entail handling access control of healthcare record to patient. Institution has little incentive to pay for the cost of setting up a blockchain just to give patient more control even though this will improve interoperability. To overcome this, a few proposals have been made:
Expand federal incentives to patient-controlled medical record.
Researchers can be incentivized to pay for the setup of these blockchains by gaining access to patient anonymized data for research purposes.
Storage of Health Care Data
Most of the previous examples use the blockchain not as a direct data storage medium, but instead as a secure reference point for identities, access, and data locations. At least one group from a company called Tierion, which partners with the Philips Blockchain Lab, has produced a concept called Chainpoint[26], which proposes to use a Proof of Existence concept and Merkle Roots[27] to efficiently store actual patient records on the blockchain without imposing excessive transaction demands on the system.
Billing and Claims Adjudication
Blockchain system can help reduce administrative costs and time while automating claims adjudication and payment processing using smart contracts. For example – a smart contract is set up between payer or insurance company, provider, and patient such that when the patient sees a provider, or if a procedure is done, an entry is recorded in the blockchain. Based on the criteria set, the contract can automatically issue reimbursement from the payer as well as co-pay from the patient without having to wait for the insurance approval.[28]
Drug Supply Chain and Prescription Management
Counterfeit drugs are a major problem especially in the developing country where it is estimated that about 1 in 10 medical products are counterfeit [29]. Ensuring the integrity of the drug and maintaining a robust audit trail is a must to ensure patient safety. Similarly, this platform can be used in prescription drug management and track history and authenticate prescriptions using smart contracts.
Few Examples of Current Use Cases and Future Development
MedRec- it is based on Ethereum platform and focuses on medical data management using smart contracts like managing permissions and authentication processes, data sharing in an interoperable environment between healthcare systems and maintaining an audit log. [30]
Guardtime- also focuses on medical data management and has partnered with e-Health authority of Estonia to secure the country’s database of health records [31]. Also, recently, MyPCR smartphone platform from Guardtime has partnered with Instant Access Medical and Healthcare Gateway in the UK for patient health data management and verification of medication adherence. [32]
Blockchain Health- created for healthcare research data management where users can individually authorize the release of their health information to researchers as well as track the use of their data. [33]
BlockMedx- it is a startup company which intends to use the blockchain platform to transmit DEA controlled drug prescriptions from physicians to pharmacies and then to patients securely. [34]
MediLedger- another pharmaceutical supply chain management startup company who has partnered with several drug manufacturers and aims to provide an open, secure, and interoperable network. [35]
Drug and Pharmacy Verification – VeriPharm has developed a proof of concept that would help track and verify pharmaceuticals from the raw materials to the final product administered to patients.
Appointment Scheduling on the Blockchain – dhva-apointment-blocks
Care Coordination – Projects such as simplyvitahlth are geared toward coordinating care between multiple providers and at different institutions to ensure that complex care pathways are being followed appropriately.
There are many more potential use-cases for blockchain technology within healthcare, and undoubtedly, we will continue to see development in this area in coming years. In 2016, a consortium of sponsors led by Gem (Whitepaper)[36] held the first healthcare oriented blockchain conference, Distributed: Health in Nashville, TN. Similarly, the Office of the National Coordinator (ONC) Tech Lab had issued a Blockchain Challenge in July 2016.[37]
As the healthcare blockchain community grows, gatherings such as these will likely increase and blockchain technologies will increasingly be introduced at major medical conferences.
Further Reading:
14 Major Real Use Cases of Blockchain in Healthcare
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