[This post has been authored by Sindhu A., a final year student at School of Law, Christ University.]
In terms of organ donation, India is ranked among the lowest globally, with an organ donation rate of a mere 0.86 donors per million. According to a recent study, around 5,00,000 people need organ transplantation every year and 90 percent of the people on the waiting list die without receiving an organ. India was known as the most common source of organ trade and although there was a gradual decline with the enactment of legislations, the illegal underground market persists as a looming threat. The above-mentioned statistics indicate the need for a fundamental change in the way the Indian organ network operates. One of the most efficient ways to remedy this is to appropriate blockchain technology to better manage organ donation and allocation.
The legal framework and challenges
India enacted the Transplantation of Human Organs Act (THOA) in 1994. The Act subsequently underwent an amendment in 2011 and the Transplantation of Human Organs and Tissues Rules (THOT) was notified in 2014. Despite having provisions to regulate the removal, storage, transplantation of human organs and to prevent commercial dealings of organs, the system faces a multitude of challenges which require immediate attention.
As identified by the National Organ Transplant Programme, there is a paucity of available organs compared to the demand for it and the situation with improvident means of communication between donors and recipients only makes the situation worse. In certain situations, decisions regarding matching donors to recipients can’t be made on schedule because if a donor is unrelated to the recipient in living organ donations, then the protocol demanded by the THOT Rules, 2014 might result in systemic delays. In certain instances, doctors have seen this as an opportunity to profit out of fabricating documents to establish fraudulent relations between a donor and recipient.
Despite the provisions in THOA, 1994, there is a colossal lack of transparency in the system, which has ultimately resulted in the manipulation of waiting lists. One such incident was documented in Chennai in 2018 when Indian patients on the waiting list were circumvented to facilitate transplants for foreign nationals. According to a study conducted by ORGAN India, in matters relating to the recipient of an organ, a surgeon makes the decision in 27.3% of the cases, while in 36.4% of cases, the organ is allocated on the basis of ‘first come first serve’.
Lack of uniformity across states due to ‘health’ being a state subject under the Constitution and due to lack of transparency as discussed above, private hospitals charge arbitrary prices for organ transplantations. The government rate for a liver transplant is Rs. 14 lakhs while most private hospitals charge around Rs. 6-10 lakhs more than the government rate.
One of the primary complications faced by the current system is that the recipient lists maintained at the Centre are not linked with the State and Regional lists. There isn’t a unified registry or an integrated list of waiting patients, donor details or information regarding transplantations conducted.
Utilization of blockchain for organ donation facilitates fair allocation of organs and efficient matching of donors and recipients, which may prove to be rewarding.
Blockchain, Hyperledger Fabric and legal challenges
The most revered features of the blockchain technology are security and immutability. Once a transaction is recorded, it remains irreversible and unforgeable and these transactions are secured with cryptographic safeguards, this reinforces trust and transparency in the system. In 2015, ‘Hyperledger’ was introduced to further the application of blockchain in a more secure and private environment. It is an open sourced distributed ledger technology launched by the Linux Foundation with architecture to deliver high degrees of confidentiality, resiliency, flexibility, and scalability. Hyperledger Fabric is one kind of blockchain technology within the hyperledger. The primary distinction between a blockchain and a hyperledger fabric is that the latter is a private and a permissioned network that uses a Membership Service Provider (MSP) for user authentication.
Using this decentralized and immutable technology to allocate and donate organs, a uniform and transparent list of donors’ details and patients on the waiting list across the country can be generated. The issues surrounding the manipulation of waiting lists, demand of arbitrary prices by private hospitals, delays in finding accurate donor matches, verifying identities and establishing genuine relationships between donors and patients will be resolved effortlessly. These aren’t just abstract concepts anymore, scholars and policymakers in different countries have made it a reality. A student of the San Jose University created a prototype, as part of his Masters’ theses, for a blockchain-based Organ Procurement and Transplant Network (OPTN) using a Hyperledger Fabric framework. Apart from this, there are a few scattered examples across the world where organisations have accommodated blockchain, and hyperledger fabric to enhance organ donation processes. Initiatives such as ‘transplantChain’, ‘Kidner’ project and the United Arab Emirates’ (UAE) blockchain-enabled mobile app called ‘Hayat’ are such examples.
However, certain fundamental legal challenges such as jurisdictional issues, privacy and data protection among others, need to be addressed before employing blockchain technology. The nodes on a blockchain may be located in any part of the world and it poses a significant challenge to verify if transactions on blockchain are complying with the laws and regulations of that jurisdiction. Another compelling legal challenge is protecting the users’ privacy and personal data, given the crucial nature of data such as health records that may be shared or recorded on this network. Since all the data that is uploaded onto the blockchain is immutable and remains on the network forever, it is inconsistent with the ‘right to be forgotten’ as provided under India’s Personal Data Protection Bill. These legal issues, among other significant ones, can only be remedied with legal intervention or policies to contribute to the credibility and efficient management of blockchain technology.
Owing to the immense growth in blockchain innovation in healthcare, several countries have attempted to ensure that these innovations are in accordance with their existing data privacy and healthcare regulations. Some instances of standards for personal data collection and obligations for processing the same are set out in the European Union’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act of 2018 (CCPA), similar to those guaranteed in India’s Personal Data Protection Bill. Apart from the data protection laws, it is ensured that organ donation on a blockchain network is in accordance with existing healthcare regulations. The above mentioned proposal of a blockchain based OPTN network was modelled keeping in mind the essentials under the Bylaws of Organ Procurement and Transplantation Network by the Health Resources & Services Administration of the United States along with requirements under the Health Insurance Portability and Accountability Act (HIPAA). Similarly, the UAE government ensured that ‘Hayat’ was in consonance with Federal Decree Law No. 5 of 2016 on Regulation of Human Organs and Tissue Transplantation and in line with the vision of the Emirates Blockchain Strategy 2021.
The Privacy and Electronic Communications Directive, 2002 (E-Privacy Directive) proposed in the EU deals with data privacy issues specifically in electronic communications. The Directive mandates specific rules and safeguards to be adopted by service providers and networks to ensure the users’ right to privacy and confidentiality. India’s Ministry of Health and Family Welfare released the Electronic Health Record (EHR) Standards in 2016, to propose a uniform system of maintaining electronic health records across the country. Along similar lines, the Ministry also proposed a draft of the Digital Information Security in Healthcare Act (DISHA) in 2017 which sought to propose e-Health standards and enforce privacy & security measures for electronic health data, and to regulate storage and exchange of EHR.
However, it is pertinent to note that blockchain technology was not the primary consideration of the legislators while enacting these laws and some concerns that are unique to blockchain technology such as anonymity, immutability, identifying data processors and collectors, and jurisdictional concerns remain largely unregulated.
India should strive to improve its organ donation rates and attempt to bridge the wide gap between the availability of organs and patients by taking initiatives to adopt a more positive approach towards organ donation. Awareness about the benefits of technologies such as blockchain must reach a large audience to establish trust in these systems. Policymakers need to draft inclusive privacy policies for governing these new technologies to instil faith in them. Privacy concerns are among the primary apprehensions of users of a new technology and hyperledger was specifically designed to create a more secure environment. However, if these technologies are not regulated, then its implementation becomes formidable.
Due regard must be given to formulating policies and regulations to govern blockchain and supplementary technologies and it is the need of the hour because blockchain has a vast potential to revolutionize healthcare, among other industries. After adopting the above-mentioned measures, creation of a blockchain platform or a hyperledger fabric framework will streamline organ donation and allocation processes and it will contribute to India’s path towards a digital future in healthcare along with saving millions of lives.