The main challenges in global healthcare today are: Data Silos, Data Provenance, Securing personal health information (PHI), and Patient Engagement. The Blockchain addresses all of these issues and creates the opportunity to gain a 360° View of a patients’ health status. However, this patient centric approach bridges both DSCSA and 21st Century Cures requirements. The necessity to alert patients to medication recalls, prevent counterfeit medications from entering the legitimate supply chain, and to proactively gather Phase IV (post marketing surveillance data) are critical to ensuring a safe, efficient, and innovative medication supply chain. With interoperability having been solved in the US, the key is patient engagement which allows them to control the use of their data, work toward improved outcomes, and benefit financially from the secure sharing of that information.

ADLT™ was designed to solve the basic challenges faced in global healthcare by creating an interoperable platform that eliminates data silos and creates the provenance of data required for business, regulatory, and patient care reasons. The platform links Manufacturer to Patient and the Patient to the rest of the healthcare system and empowers them to control their care and be incentivized for succeeding. By focusing on the needs of the patients, it is possible to leverage the power of the Blockchain and present it in a user friendly manner so that information can be shared efficiently across the entire spectrum of a patient’s health life cycle. It allows for direct patient engagement by industry or providers at a time and choosing of the patient to gather information regarding outcomes, the type of adverse effects being seen and provide educational information and tips for success.

The key characteristics of a healthcare oriented Blockchain should be user friendly, as easy to deploy as MS Office, and be of Enterprise Quality. Based on these criteria, we have chosen to work with Intel’s Hyperledger Sawtooth Lake and the Coco Framework they have co-developed with Microsoft. Coco framework is designed to be Enterprise Ready and will be interoperable with multiple Blockchain Solutions. Interoperability is one of the key limitations of deploying solutions to production as there will not be one Blockchain Solution for an industry, but many. The ability to join solutions or switch from one to another based on an organization’s need and requirements is critical to the success of Blockchain technology in healthcare.

However, the Blockchain is only one component of an interconnected health system. The benefit of a Blockchain backbone is that data from IoMT, AI, Finance can securely record information so that the healthcare team can evaluate the patient’s progress on a more longitudinal basis. Additionally, as Blockchain removes data silos, it can be the conduit of much needed data for the training of AI systems, improve regulatory reporting, and assist in gather data to validate current clinical guidelines.

To demonstrate the depth and breadth of Blockchain applications for the BioPharma and Healthcare Supply Chain, I will describe several uses cases the rationale for their use.

The first use case I will describe is the movement of medications from Manufacturer to patient. For this use case, we addressed the DSCSA requirements around Track and Trace, Borrow and Loan, and Saleable Returns. We went beyond the DSCSA requirements and also showed how automated and directed the recall process could be along with a way to prevent counterfeit medications from entering the legitimate supply chain. This was recently presented at the Center for Supply Chain Studies Meeting at the end of April in Rockville Maryland.

The next use case will be a high level overview of how ADLT™ can assist with the tracking of high risk and addictive medications through the BioPharma and Healthcare Supply Chains.  We will also examined how other key non-healthcare resources such as social work and economic development can be connected to allow individual to connect with resources to not help improve their health, but to also deal with any untoward  outcomes during treatment.

The Blockchain has a wide range of applications throughout BioPharma and Health Care along with Medical Devices and other segments of the Life Sciences Industry. It is possible by interconnecting the entire ecosystem to create a 360° view of the movement and use of medications. By taking a patient centric approach and focusing on interoperability and data provenance, the ADLT™ platform can resolve multiple industry challenges and become a key component in improving patient outcomes.

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