Healthcare Life Sciences Business Action Group (HLS BAG)

The mission of the HLS BAG is to identify Healthcare and Life Science end-user business requirements to the EPCglobal standards development process and promote the adoption and implementation of the EPC and the elements of the EPCglobal Network.

The BAG will accomplish its Mission through the following:

• Chartering Work Groups to explore application areas and initiate, refine and complete Use Cases for forwarding to the technical Action Groups.
• Ratifying the technical specifications of the technical Action Groups as meeting the requirements of user Business Action Group requirements.
• Providing a forum for the interaction of End Users and Solution Providers to collaborate on the definition of user requirements and the understanding of solutions to those requirements.
• Providing a forum to share learnings from pilots and implementations of the EPCglobal Network.
• Acting as the primary representative body of users of the EPCglobal Network and coordinating the activities of the BAG with those of other groups that may contribute to the work of driving adoption of the EPCglobal Network.
• Representing a global scope of interest in the EPCglobal Network by users and ensuring that geographic opportunities and challenges are recognized. It is the intention of the BAG to recognize global scope through Use Cases rather than through the chartering of separate user groups on different continents or in different countries.

The HLS BAG Working Groups include:

Information

• Recommend information business requirements and related process for the Healthcare and Life Sciences supply chain for use cases as identified and prioritized by the Strategic Planning Work Group. The initial priority will be on the "safe and secure supply chain use case" (Refer to attached Scope Definition). The recommended business requirements and processes would include: numbering systems, data retention, data ownership /visibility / information sharing and EPC number assignment processes.
• Create information business requirements supported by meta data standards would allow supply chain partners to communicate business sharing with a common set of elements, as well as enabling healthcare stakeholders to effectively utilize RFID within their internal processes.
• Recommend business requirements that would ensure that the HW and SW development groups have the requirements and incorporate the standards needed to support various Healthcare business processes. The Information Working Group will propose business requirements based on existing healthcare protocols and needs while evaluating their adequacy when using RFID technology.
• Provide an Information framework encompassing business protocols and methodologies from a board healthcare constituency to communicate their RFID related data practices to consumers, internal and external business partners.

Policy

• Promote the adoption of RFID and EPC technology within the healthcare supply chain by developing opportunities for the enabling regulations, guidelines and mandates to be enacted, promoted or enforced through existing industry channels of communication and bodies of influence.
• Achieve the business use case objectives set forth and prioritized by the HLS Strategy workgroup and the aligned with the deliverables of each supporting HLS workgroup, by:
  • Identifying the key stakeholders involved in each use case and deliverable and determining where regulatory compliance, public policy, privacy, security, patient and consumer education, and business policy matters may be involved.
  • Soliciting input from and collaborating closely with industry experts to determine which regulations, guidelines and mandates may be either enabling or impeding to the cause of advancing the stated use case objectives and deliverables of the HLS Working Groups
  • Educating and strategically advising the HLS Working Groups on policy matters specific to their individual deliverables by formally presenting factual information, educated opinion, and informed recommendation.

Process

• Develop business processes as defined and prioritized by the Healthcare and Life Sciences Business Action Group Strategic Planning Working Group.
• Develop the business processes that will outline the key EPCglobal HLS BAG use cases and define the underlying process descriptions and scenarios that will assist in identifying RFID enabled information and technology requirements, especially those requiring the definition of global standards vetted by the EPCglobal.
• Provide specific input to EPCglobal Strategy, Technical and Business Action Groups, and other standards-setting bodies in the extended healthcare and life sciences supply chains as related to the application and use of RFID technology to track, trace and authenticate articles of commerce.
  • Development of specific Use Cases, and Scenarios, which describe in detail (i) the route traversed by articles of commerce and (ii) business interactions involved at each node of the supply chain, focused initially on compliance with pedigree laws and FDA guidelines.
  • The scope of the Use Case includes all nodes beginning at the point of Pharmaceutical Packaging and ending at the decommissioning at the Hospital or Retail Pharmacy.

Research and Development

• Develop requirements for further research as defined and prioritized by the Healthcare and Life Sciences Business Action Group Strategic Planning Working Group.
• Review and summarize the existing research on the effect of RF on products, humans, and the environment.
• Survey the major stakeholders in pharmaceutical applications of RFID technology on the research they have performed, the areas in which research is continuing, and their willingness to share results.
• Coordinate with academic RFID thought leaders to assess the state of the art in RFID research, including MIT, Michigan State, and the University of Adelaide, Australia.
• Examine and summarize research on the effect of Cold Chain on RFID technology.
• Review research concerning the effect of sterilization procedures on tag performance.
• Determine plausible scenarios and timelines for sensor technology development.

Strategic Planning

• Develop and manage the execution of a Strategic Work Plan, designed to coordinate and prioritize the activities of Work Groups within the HLS BAG.
• Provide specific input to EPCglobal Technical and Business Action Groups, and other standards-setting bodies, as appropriate, regarding the requirements for standards, policies, and agreements between and among trading partners and regulatory bodies in the extended healthcare and life sciences supply chains as related to the application and use of RFID technology in general, and the EPCglobal Network, specifically, to track, trace and authenticate articles of commerce.
  • Relative to the HLS BAG goal of providing for a safe and secure supply chain for pharmaceutical products, we will commission the development of specific Use Cases, and Scenarios, which describe in detail (i) the route traversed by articles of commerce and (ii) business interactions involved at each node of the supply chain, focused initially on compliance with international laws and regulations, State pedigree laws and US FDA guidelines (see "Combating Counterfeit Drugs: A Report from the Food and Drug Administration", February 18, 2004).
  • Commission the development of specific Use Cases, and Scenarios, which describe in detail (i) the route traversed by articles of commerce and (ii) business interactions involved at each node of the supply chain, focused on elements that may include enhancing supply chain efficiencies, improving care provider efficiencies and effectiveness, and enhancing the patient/consumer experience, compliance, and safe usage. It is recognized that medical and surgical devices, over-the-counter medications, vaccines and biological materials, durable medical equipment, and many other specific examples of goods, other than strictly pharmaceutical products, must be addressed in these Use Cases and Scenarios.
  • Prioritize the critical path elements needed to support End User implementations of EPC systems and the EPCglobal Network.
• Provide for collaborative, focused interaction among EPCglobal End Users, member companies, Staff, other BAGs and Work Groups, and appropriate Work Groups of the HLS BAG regarding the work and priorities of the individual Work Groups.
  • Identify cross-Work Group issues and concerns, coordinate and help facilitate collaboration to prevent duplication of effort, ensure timely progress towards desired outcomes.
  • Provide visibility into the prioritization and Work Plan process.
• Ensure that the HLS BAG Strategic Work Plan remains aligned with the business priorities of EPCglobal subscriber companies.
• Actively recruit members to ensure global participation in the process of providing input to the development of appropriate standards, and include representation from all segments of Healthcare & Life Sciences businesses.

Technology

• Serves as a technical resource to the other work groups inside the HLS BAG.
• Investigate specific issues that those work groups may pose to the Technology WG.
• May also serve as the primary author of some use cases and other business / functional requirements documents on behalf of the HLS BAG, depending on the nature of those use cases.
• Address technology issues as defined and prioritized by the Healthcare and Life Sciences Business
• Action Group Strategic Planning Working Group. Topics for consideration as use cases could come from (a) the chairs and other work groups of the HLS BAG, (b) the EPCglobal HAG and SAG members seeking more detailed requirements to support their work, and (c) the Technology work group's own investigation and research into EPCglobal technology challenges. In this latter case, the Technology WG will identify and prioritize issues, and recommend work plans to create the appropriate requirements documents.

FMCG & HLS Joint Working Groups

The mission of the FMCG and HLS BAG Joint Working Groups are to collaborate on areas of overlap between the two BAGS and identify a single set of business requirements to the EPCglobal standards development process.

The FMCG & HLS Joint Working Groups include:

Applied Tag Performance Working Group

• Create performance tests specifications for applied tags whether it be the primary, secondary or unit load. These specifications will be designed to conform to specific regulatory bodies that exist in Europe, Asia and North America.
• Develop, publish and maintain EPCglobal laboratory accreditation criteria for Applied Tag Performance (ATP) evaluation by defining & developing ATP methodologies; and publishing, maintaining & updating ATP Specifications (Standard Specifications in EPCglobal nomenclature) for EPCglobal accredited labs.
• Develop, publish and maintain an EPCglobal laboratory accreditation process for site certification of ATP Specifications conformance by defining certification requirements and processes.
• Act in an advisory capacity to EPCglobal to promote adoption.

Physical meetings of the HLS BAG are held on a quarterly basis. Conference calls are held on a weekly basis or as needed by each Working Group.