Product supplies, from initial inception to end-of-life, is the most prevalent use case for DLT across industries. In healthcare, medication, clinical supplies, blood products, and medical devices are examples where blockchain is being leveraged for operations, compliance, and forecasting among pharmaceutical manufacturers, blood banks, providers, pharmacies, and payers. Translating bring your own device (BYOD) from the workplace to consumer devices, and identifying and tracking consumer, wearable, and Internet of Things (IoT) devices are additional use cases that support patient-generated data.
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Medical Device Supply Chain and IoT
Similar risks that are seen with the drug supply chain exist for medical device supply chains. These can range from quality optimization issues to critical devices with a history of security vulnerabilities like cardiac pacemakers. Medical device supply chain management benefits from a degree of harmonization as the US and EU both require Unique Device Identifiers (UDIs) and leverage those by means of the Global Unique Device Identification Database (GUDID).
Early efforts for this use case include a private-public relationship that includes Edinburgh Napier University, NHS Scotland, and New Jersey and Scotland-based Spiritus Partners. While an emerging technology (and emerging risk category), the Internet of Things (IoT) as it applies to healthcare as IoHT (Internet of Healthy Things) or IoMT (Internet of Medical Things) have already had reports of wearable technology market leaders and related sensors being compromised.  As consumer-grade health devices continue to be connected to larger data repositories, new vectors will likely be identified and they are likely to increase as targets for bad actors.
Pharmaceutical Supply Chain
Specifically with regard to the drug supply chain, authenticity, provenance and safety of drugs, and tracking data for products are required for compliance with regulations such as the U.S. FDA Drug Supply Chain Security Act (DSCSA). The DSCSA specifies key requirements that the requisite electronic and interoperable solution employed to satisfy it must have. The table below maps blockchain elements to DSCSA mandates. Companies exploring the use of blockchain for the health supply chain include Chronicled, FarmaTrust, iSolve, and Viant (with GSK).
Table. Blockchain compatibility with DSCSA key requirements
Clauson et al. Blockchain in Healthcare Today 2018;1. doi: 10.30953/bhty.v1.20 via Creative Commons license.
|Product identification||Unique product identifier can be required with contributed information validated as a side chain|
|Product tracing||Allows manufacturers, distributors and dispensers to provide tracing information in shared ledger with automatic verification of important information|
|Product verification||Creates system and open solution to verify product identifier and other contributed information|
|Detection and response||Allows public and private actors to report and detect drugs suspected as counterfeit, unapproved, or dangerous|
|Notification||Creates shared system to notify FDA and other stakeholders if an illegitimate drug is found|
|Information requirement||Can create shared ledger of product and transaction information including verification of licensure information|