HDA’s 2023 DMA Winners Discuss DSCSA Credentialing and the Value of Collaboration
With the Drug Supply Chain Security Act (DSCSA) implementation deadline on the horizon, HDA members and industry partners are driving innovative solutions to support trading partner compliance. One of the notable examples of this collaboration is demonstrated by HDA’s 2023 Distribution Management Award (DMA) recipients, Spherity and Legisym.
We spoke with Georg Jürgens, Spherity’s Manager of Industry Solutions, and David Kessler, President and Partner of Legisym, about their companies’ histories, award-winning DSCSA solution and collaboration driving innovation within the healthcare distribution supply chain.
HDA: Tell us a little bit about Spherity’s origin and growth?
Jürgens: Spherity is a German software provider developing secure and decentralized enterprise identity management solutions. Since its founding in 2017, Spherity has been active in technological research and pilot projects in various sectors worldwide, including healthcare. We won second place in the FinTech Germany Award 2020 and were a founding member of IDunion in 2021.
The SAP.io Start-up Accelerator in Berlin in 2019 directed us to the U.S. pharmaceutical supply chain. In the following years, Spherity was one of the driving forces behind maturing digital credentialing as an industry-wide interoperable electronic solution for DSCSA Authorized Trading Partner (ATP) authentication — including our co-founding of the Open Credentialing Initiative (OCI) in 2021. These efforts culminated in the launch of a commercial product in 2022 and winning the HDA DMA in 2023.
HDA: Tell us a little bit about Legisym's origin and growth?
Kessler: In 2008, three entrepreneurial business owners and software developers set out to create the first and only 100 percent web-based controlled substance ordering system (CSOS) solution. By January 2009, Legisym’s flagship CSOS solution, Express222™ was certified by the Drummond Group. After building trust with clients for about a decade, many came to us about an industry gap, which led to the launch of License Verify™ in 2018.
In early 2020, driven by the 2023 ATP requirements under the DSCSA, Legisym began leveraging their experience and existing technologies toward a new offering, Credential Solutions™. By performing thorough credential issuer due diligence and monitoring services, in alignment with both OCI’s Credential Issuer Conformance Criteria and the Partnership for DSCSA Governance’s (PDG) Foundational Blueprint for 2023 Interoperability, Legisym promotes confidence in trading partner digital identities and ATP status through interoperable, verifiable credentials.
HDA: What role do credentialing solutions and systems play in enabling DSCSA compliance, and how do they impact the healthcare supply chain?
Jürgens: For context, we define credentialing as the process of creating W3C-specified cryptographically verifiable credentials based on provable claims made by an entity. In regard to DSCSA compliance, credentialing refers to the process of converting a pharmaceutical supply chain actor’s documentation into verifiable credentials, with ongoing due diligence after. This enables supply chain actors to prove their valid ATP status in electronic interactions, which may be fully automated, as is the case with Verification Router Service (VRS)-facilitated Product Identifier (PI) Verifications, or semi-automated, as is envisioned for product tracing processes. This process ensures that bad actors are not using public information to infiltrate the U.S drug supply chain.
Spherity and Legisym follow OCI’s conformance criteria to provide these services to the market. While DSCSA allows for up to 24 hours, our credential-based system can handle both the ATP and the PI verification requests within less than one minute.
Kessler: In a world of digital exchanges with both direct and indirect relationships, it can be challenging to verify business identities efficiently. Companies use credentialing to pre-establish and demonstrate the authenticity of a trading partner’s identity and DSCSA-defined authorized status before exchanging information. This is done to severely restrict or altogether deny access to the U.S. pharmaceutical supply chain by unauthorized trading partner users. While historically credentialing has been a very manual process, digital credentialing solutions provide a fully electronic, interoperable format.
Empowered with a W3C Digital Verifiable Credential conformant to the OCI and PDG, U.S. pharmaceutical supply chain entities can trust exchanges within the DSCSA Enhanced Drug Distribution Security (EDDS) network — enabling safe and efficient electronic data exchange backed by clear audit trails of interactions and due-diligence processes.
HDA: Please talk to the importance of collaboration between trading partners and healthcare supply chain stakeholders in regard to DSCSA implementation, preparation and compliance?
Jürgens: True industry-wide innovation does not happen in isolation. The key to the rapid development of our workable ATP authentication solution and OCI’s growth was the pioneering spirit of a variety of collaborative organizations. The resulting solution demonstrates how important it is to create a space where participants can freely exchange ideas, practical insights and co-create for a shared purpose.
Kessler: As the DSCSA EDDS network becomes more interoperable, it can only be as strong as the weakest link. All network participants must hold the same level of security and basic thresholds for demonstrating the authorized status of a trading partner prior to exchanging sensitive product information, which further secures the supply chain — and protects patient access to safe drugs.
With the volume of electronic interactions increasing in 2023 between trading partners without an established commercial relationship, so does the importance of having a refined process for product verifications and tracing.
HDA: Your partnership recently received HDA’s Distribution Management Award (DMA). Please share what this recognition means to you?
Jürgens: Developing a solution that increases healthcare supply chain security in a cross-industry pilot has been an incredible journey. Seeing the work of Spherity, Legisym and our partners, and the value of credentialing, recognized by such a prestigious award is the icing on the cake. We are grateful to HDA for including our ATP Pilot partners on the trophy and in recognition statements. It really shows that this was, and still is, a collaborative venture intended to support the entire U.S. pharmaceutical supply chain.
Kessler: We are grateful for everyone at OCI and PDG for their commitment and collaboration on establishing this framework. Since its inception, our vision has been to allow for industry-wide interoperability and adoption through an open standardized approach that anyone can participate in. It is great for the OCI ecosystem to be recognized.
HDA: Given the award was presented at HDA’s Distribution Management Conference and Expo (DMC), tell us about your experience at the event and how your involvement with HDA has helped your companies.
Jürgens: DMC was a wonderful opportunity to meet pilot participants and fellow OCI members and supporters in person — some for the first time! Many DMC attendees congratulated us and were curious to learn more about credentialing; the DMA helped create interest and visibility.
HDA has been a valued partner since the ATP Pilot and within OCI. We appreciate HDA’s support, especially the work of Jaidalyn Rand [HDA Director of Industry Relations] and Tim Stearns [HDA Senior Director of Industry Relations], in connecting us with the group of VRS providers that helped us understand the DSCSA technology provider ecosystem — and how we can provide support.
Kessler: As a solution provider, Legisym continues to find our now 12 years of HDA membership imperative to staying connected to the industry. Each year, Legisym commits to HDA's DMC as an engaged attendee, exhibitor and sponsor, ready to converse about regulatory compliance topics and learn from the educational sessions. During this year’s event, our team attended the full offering of DSCSA-related sessions and especially benefited from the open panel discussions.
HDA: Anything else you would like to highlight or share?
Jürgens: Even though Spherity more or less stumbled upon the challenge of DSCSA ATP authentication, protecting patient health was exactly the kind of purpose we had been looking for as a young start-up. We want to make real contributions to society and the public good, and this DSCSA use case is an opportunity for others to understand the tremendous potential of credentialing based on open standards. To continue innovating will require ecosystem collaboration, as was demonstrated by our work in OCI and with HDA and pharmaceutical supply chain partners.
Kessler: Digital verifiable credentials for DSCSA ATP are based on open standards, so the technical documentation created is publicly available through OCI and PDG. The architecture can be implemented by any company seeking to fulfill one of the roles, thereby ensuring vendor lock-in is mitigated for trading partners. We encourage pharmaceutical supply chain entities to explore the information and ensure you are prepared for November 27, 2023!
To learn more about DSCSA and the upcoming implementation deadline, visit HDA’s traceability webpage for resources.
Note: This interview has been condensed and edited for clarity.