During the recent years we have seen a significant growth of Electronic Medical Records (EMR), mainly driven by legal compliances, need for efficiency and cost-effectiveness and above all proven effective for providing quality care by using the data for preventive medical care. in various parts of the world. To provide proper and timely treatment to a patient (conscious or unconscious) anywhere, availability of patient’s EMR prove to be extremely important. EMRs need to be swiftly and seamlessly accessible to the health care providers at the time of need. Patients may receive treatment from a diverse range of health care providers across many cities or countries. However, there is lack of interoperability between the EMR systems of one health care provider to another, even in the same city or neighbourhood making it impossible to access patient’s medical history without consulting the previous care provider(s) or paper files maintained by the patients.
According to Regulation (EU) 2016/679 of the European Parliament, citizens have the right to access their personal and health data, but most citizens are not yet able to access nor securely share their health data across a border (European Commission, 2019). The European Commission recommendation of 6 February 2019 on a European Electronic Health Record exchange format mentioned as an example that, “sharing the results of blood tests in a digital format among clinical teams prevents repeating invasive and costly tests on the same person. Similarly, where patients need to see different health professionals, sharing electronic health records can avoid a repetition of the same information about their medical history saving time for all parties involved and improving the quality of healthcare”. Due lack of interoperability between the EMR systems, there are process inefficiencies, redundant costs, loss of precious time for assessing medical conditions and knowing the medical history of the patients; and even life-threatening mistakes can happen due to human error or other mishaps. The European Commission (2019) recommendation highlights that “lack of interoperability with regard to electronic health records leads to fragmentation and a lower quality of cross-border healthcare provision and that the highest possible standards for security and data protection are central to developing and exchanging electronic health records”.
Electronic health records (EHR) can be hard and complex to manage. long-term preservation and storage of EMR is a prerequisite as it serves for life long usage of a patient as well for family history. Besides this, data privacy and regulations compliance requirements such as, for the US Health Insurance Portability and Accountability Act of 1996 (HIPAA) for data storage, sharing, and protection in the healthcare sector. Cross-border interoperability for EMR as different countries may have diverging legal requirements for the content or usage of electronic health records, which can require radical changes to the technical makeup of the EHR implementation in question (Anon, 2019b). Current EMR Systems are probably using one or more, or none of the standards listed below storage and exchange (Anon, 2019b). How to have them communicate and share records between each other and implement recommendations of the European Commission (2019) such as:
“Digitising health records and creating systems that enable them to be securely accessed by citizens and securely shared within and between the different actors in the health system (patients, their clinical teams in the community and hospital facilities)”.
“Electronic health records, to be interoperable across the Union (even Globally) whereas currently many of the formats and standards in electronic health record systems – that are information systems for recording, retrieving and managing electronic health records –used across the Union are incompatible”.
EMR Standards list (Anon, 2019b) :
- ASC X12 (EDI) – transaction protocols used for transmitting patient data. Popular in the United States for transmission of billing data.
- CEN’s TC/251 provides EHR standards in Europe including:
- EN 13606, communication standards for EHR information
- CONTSYS (EN 13940), supports continuity of care record standardization.
- HISA (EN 12967), a services standard for inter-system communication in a clinical information environment.
- Continuity of Care Record – ASTM International Continuity of Care Record standard
- DICOM – an international communications protocol standard for representing and transmitting radiology (and other) image-based data, sponsored by NEMA (National Electrical Manufacturers Association)
- HL7 – a standardized messaging and text communications protocol between hospital and physician record systems, and between practice management systems
- Fast Healthcare Interoperability Resources (FHIR) – a modernized proposal from HL7 designed to provide open, granular access to medical information
- ISO – ISO TC 215 provides international technical specifications for EHRs. ISO 18308 describes EHR architectures
- xDT – a family of data exchange formats for medical purposes that is used in the German public health system.
There are several properties of the Blockchain technology that can be used for the benefit of EMRs.
- Immutability to enable the creation of incorruptible databases for medical records. As mentioned earlier that Blockchains, are designed as distributed systems that record and protect files through the use of cryptography and that it is extremely difficult to disrupt the Blockchain or modify data once stored.
- The peer-to-peer architecture, decentralization and data distribution used in Blockchains can allow copies of a patient’s record to be synchronized with one another as updates are made, even though they are stored in different systems (nodes), keeping data up to date and authentic.
- In the case of EMR Blockchains can be distributed but not necessarily decentralized as public. In terms of governance, private Blockchains can be used requiring permissions designed as per requirements, allowing authorized parties to access patient data and other related records.
Looking at the worldwide requirement for health care systems, the diversity, approach, specialisations and continued medical science innovations in treatments, preventions, methods, tools and processes it is easy to imagine that there will not be a one size fit all solution for a global EMR system or standard to store EMRs. As it is Blockchain technology too has its limitations. Therefore, its best to use what it is best for.
Linn and Koo (n.d.) proposed “use of a public Blockchain as an access-control manager to health records that are stored off Blockchain”. As they describe, healthcare Blockchain would need to be public and should include key elements like scalability, access security and data privacy. While access security and data privacy of health records can be well managed using Blockchains storage can be a challenge. EMR documents or images would have data storage implications. Access and updates to the EMR system should also be fast and Blockchains are not fast in that aspect.
In using Blockchain as a global access-control manager scenario rather than attempting to interface with each other’s’ EMR system internal storage directly or through API’s, health care service providers systems can work through a common Access Control Blockchain Manager. It would mean that
- Each healthcare provider uses the best suited EMR system and their data remains within that system (as required)
- Access Control Blockchain Manager provides a ledger of where patient’s records are to be found and who can access. It also provides mechanisms through and key pairs to ensure only authorized parties access the data
- Linn and Koo (n.d.) propose that transactions in the blocks would contain a user’s unique identifier, an encrypted linked to the health record and other relevant details such as a complete indexed history of all medical data, including formal medical records as well as health data from mobile applications and wearable sensors, and would follow an individual user throughout his life. However, the medical data would be stored off Blockchain in a data repository that would be encrypted and digitally signed to ensure the privacy and authenticity of the information.
Besides EMR Blockchain use cases in healthcare are many with the ability to transform the entire sector. Some of the very evident ones can be listed as below:
- Blockchain technology can also help hospitals and health systems manage claims and remittances, improve the collection of patient payments, minimize denials and underpayments, as well as manage daily revenue cycles and business operations more effectively.
- It can also help in the supply chain of medical products from initial inception through the entire manufacturing and distribution process to end-of-life. It will help in countering the problem of drug counterfeiting.
- For operations compliance and logistics, especially for pharmaceutical medication, clinical supplies, blood products, and medical devices manufacturers, among blood banks, providers and pharmacies. With the combination of the use of sensor devices that measure compliance factors such as temperature, Blockchain technology can be used to monitor proper storage and shipping conditions to ensure quality.
- In the areas of health care administration and finance, Blockchain can be used for faster Claim Settlement and for Administrative & Regulatory Audit
- Blockchains can be used for tracking pharmaceuticals, thus cutting down on the widespread problem of drug counterfeiting.
- Clinical Trials Record-Keeping on a Blockchain can be useful for data sharing
Numerous implementations of Blockchain use cases in the health care sector some of them are (Sam Daley, 2019)
- BurstIQ provides end-to-end enablement of Blockchain-based health applications and services through a global, person-centric data exchange that connects these solutions to each other and to the people they serve. Their solutions claim to include Big Data Blockchain, Customizable Data Sharing & Consent Engine, HIPAA, GDPR and NIST-Compliant Security and Scalability (Bird, 2017).
- Coral Health (https://coral.health/, 2019) uses Blockchain to accelerate the care process, automate administrative processes and improve health outcomes. By inserting patient information into distributed ledger technology, the company connects doctors, scientists, lab technicians and public health authorities quicker than ever. Coral Health also implements Smart Contracts between patients and healthcare professionals to ensure data and treatments are accurate.
- FarmaTrust intends to end counterfeit drugs with their Blockchain. FarmaTrust’s Blockchain will be broken down into four different sections. Regulatory Compliance aids pharmaceutical companies by ensuring they are working within guidelines established by the government. Track and Trace uses the Blockchain to manage inventory wherever it goes. Supply Chain Visibility tracks when a medicine has been changed or altered in any way. And finally, Consumer Confidence App allows customers to see the lifecycle of their medication.
- Factom Blockchain is a decentralized publication protocol for building record systems that are immutable and independently verifiable (Factom, n.d.). It enables secure storage of digital proofs for data provenance and integrity solutions without disclosing private data or requiring trusted intermediaries. It is said to be accessible only by hospitals and healthcare administrators. Physical papers can be equipped with special Factom security chips that hold information about a patient and stored as private data that is accessible only by authorized people.
- Medicalchain (Dr. Abdullah Albeyatti, 2017) enables the user to give healthcare professionals access to their personal health data. Medicalchain then records interactions with this data in an auditable, transparent and secure way on Medicalchain’s distributed ledger.
- Guardtime(https://guardtime.com/health, 2019) is helping healthcare companies and governments implement Blockchain into their cybersecurity methods. The company was vital in helping implement Blockchain in Estonia’s healthcare systems, and it recently signed a deal with a private healthcare provider in the United Arab Emirates to bring Blockchain to its data privacy systems (Sam Daley, 2019).
- Blockpharma (Blockpharma, 2016)offers a solution to drug traceability and counterfeiting. By scanning the supply chain and verifying all points of shipment, the company’s app lets patients know if they are taking falsified medicines With the help of a Blockchain-based SCM system, Blockpharma weeds out the 15% of all medicines in the world that are fake (Sam Daley, 2019).
Anon (2019) ‘Electronic health record’, Wikipedia [Online]. Available at https://en.wikipedia.org/w/index.php?title=Electronic_health_record&oldid=901522231 (Accessed 5 July 2019).
Bird, M. (2017) BurstiQ [Online]. Available at https://www.burstiq.com/ (Accessed 5 July 2019).
Blockpharma (2016) Blockpharma | Solution blockchain de traçabilité des médicaments [Online]. Available at https://www.blockpharma.com/ (Accessed 5 July 2019).
Dr. Abdullah Albeyatti (2017) ‘Medicalchain Whitepaper 2.1’, Medicalchain [Online]. Available at https://medicalchain.com/en/whitepaper/ (Accessed 5 July 2019).
European Commission (2019) ‘COMMISSION RECOMMENDATION of 6.2.2019 on a European Electronic Health Record exchange format’, European Commission.
Factom (n.d.) Factom Blockchain [Online]. Available at https://www.factom.com/factom-blockchain/ (Accessed 5 July 2019).
https://guardtime.com/health (2019) Guardtime Health — Guardtime [Online]. (Accessed 5 July 2019).
Linn, L. A. and Koo, M. B. (n.d.) ‘Blockchain For Health Data and Its Potential Use in Health IT and Health Care Related Research’, p. 10.
Sam Daley (2019) 15 examples of how blockchain is reviving healthcare [Online]. Available at https://builtin.com/blockchain/blockchain-healthcare-applications-companies (Accessed 5 July 2019).