INSPIRE case study DECIPHER: Distributed European Community Individual Patient Healthcare Electronic Record Acknowledgement: This case-study has been produced thanks to the contribution of DECIPHER Consortium (see: decipherpcp.eu) DECIPHER PCP Project, funded under the European Commission 7th Framework Programme for research and technological development (FP7), is an ongoing project and challenges the industry to develop mobile solutions that enables secure cross-border access to existing patient healthcare portals and efficient and safe medical care of mobile patients in EU member states. These solutions (the DECIPHER Service) shall be of special interest in the management of patients with chronic diseases or unplanned care episodes. DECIPHER PCP Procedure follows the Phased Pre-commercial Procurement model described by the European Commission in the Communication "Pre-commercial Procurement: Driving innovation to ensure sustainable high quality public services in Europe", Brussels, 14.12.2007. COM [2007] 799 as well as in a EC staff working document Example of a possible approach for procuring R&D services applying risk-benefit sharing at market conditions, i.e. pre-commercial procurement SEC [2007] 1668 as a competitive procedure for acquiring Research and Development ("R&D") services. All procurement activities are conducted by the Procuring Entity as single procuring entity. The Procuring Entity is the Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), a public agency attached to the Health Department of the Regional Government of Catalonia (SPAIN). The Procuring Entity is purchasing on behalf of three procuring authorities: ESTAV CENTRO (Ente per i Servizi Tecnico-amministrativi di Area Vasta Centro) (ITAL), a Tuscany Regional Agency in charge of centralized procurement, logistics, health technology and Information and Communications Technology (ICT) support for Central Tuscany Public Health Entities (ASL10 Firenze, AOU Careggi, AOU Meyer, ASL3 Pistoia, ASL4 Prato, ASL11 Empoli and ISPO). TICSALUT (SPAIN), a public foundation attached to the Health Department of the Regional Government of Catalonia (Spain) that works to promote the development and use of ICT and networking in the field of health, acts as an observatory for new trends, innovation and monitoring of emerging initiatives and provides services for the standardization and accreditation of products. CMFT-TRUSTECH (Central Manchester foundation Trust) (UK), an United Kingdom National Health Service (NHS) organization that aims to improve healthcare through the development of innovative products and services, providing consultancy services and expert advisory to help individuals and teams to develop and commercialize or disseminate their innovative products and services, to protect their intellectual property, as well as to manage their innovations and to introduce new technologies to meet clinical needs and improve patient care. Page 1 of 8
Roles involved: Procuring entity (AQuAS): project manager, expert in innovation, legal department, contracting department, expert in evaluation of innovation, Procuring authorities (TICSALUT, ESTAV Centro, CMFT-TRUSTECH): experts in innovation, end-users, experts in technology, contracting departments to monitor current PCP and plan for future PPI. Other DECIPHER project partners (VTT, ANCI Innovazione, BDIGITAL): R&D/innovation departments responsible to analyse the state-of-the-art, set-up test environment, evaluate and monitor the bidders; dissemination departments responsible to attract bidders and disseminate the results. Status: on-going Contact person: Rossana Alessandrello ralessandrello@gencat.cat Key information Object: R&D services Demand side driven approach (need /challenge definition) Separation with the procurement of commercial volumes of end-product and no preferential treatment in the supply of the final product (re-opened competition) Absence of exclusive condition: the public purchaser does not reserve the R&D results exclusively for its own use Competitive procurement (no invitation-based or restricted procedure) Development in phases Multiple-sourcing contract Retaining at least two participating companies until the last phase to ensure a (future) competitive market Open, transparent, non-discriminatory selection procedure based on objective selection and award criteria specified in advance of the bidding procedure Contractual arrangements (including IPRs), rights and obligations allocation decided upfront and made available to all interested bidders in advance All potential bidders (including SMEs) have equal chances to bid against the same contractual condition Awarded criterion: MEAT (competition also on price) 1. Identification and assessment of unmet needs within (and starts from) the public bodies The main objective of DECIPHER project is to enable secure cross-border mobile access to existing Personal Health Records (PHRs) which are individually supported by national (governmental) bodies. DECIPHER project is making use of Pre-commercial Procurement (PCP) to create step-change innovations in mobile patient ICTs. During the Need Assessment phase (Phase 0) the procuring authorities shared their own strategic requirements and identify their common needs. They validated those requirements and needs with patients and healthcare professionals through specific workshops run at each procuring authorities Page 2 of 8
country and they identified the relevant business case. Finally they verified the concept viability with the technological suppliers and through a patent search. The outcome of this phase was a first level of definition of requirements specifications further developed together with the ITT documentation. DECIPHER came up with its own definition of Phase 0, making sure that all the steps identified in the literature are present but at the same time adding overlapping temporal windows among the different stages ensuring in this way a major efficiency in the PCP scope definition. DECIPHER Phase 0 process can be represented as per figure below: Figure 1 DECIPHER Phase 0 Process 2. Involvement of users in specification of requirements and/or piloting During the Needs Identification phase the three procuring authorities carried individual analysis at their own countries interviewing healthcare professionals, institutions and opinion leaders. Six moderated workshops took place (two in Manchester, two in Florence and two in Barcelona) to verify with citizens and healthcare professionals the identified needs and to further develop DECIPHER requirements. In total, some 30 patients and 30 healthcare professionals were consulted for this analysis. 3. SoA analysis via open technical dialogue and early market engagement The state-of-the-art study aims were to provide technical background information for the development and procurement of the DECIPHER Service. Most importantly, the DECIPHER Service requires access to Personal Health Record (PHR) data residing in national health-data repositories. There are many challenges both Page 3 of 8
technical and privacy-related - in accessing the PHRs by other applications. Therefore applications accessing PHR systems are typically tethered e.g. solutions provided by the national authorities and bound to particular EHR systems. Prior to the technical dialogue, an Horizon Scan was carried out, which consisted of a review of the Literature of scientific, technical publications and patent search to guarantee that the technological solutions developed during the project are innovative and can be protected by IPR The Market consultation consisted of the technical dialogue and early market engagement. This stage was one of the most critical for the success of the project since it was not only a way to attract bidders to the PCP programme but it was a tool to validate with the market the procuring authorities requirements, the PCP procedure (budget distribution, phases duration and awarded proposals) and technological gap. The outcomes of this phase were: The validation of the technology gap with the technology providers The validation of the PCP procedure characteristics with the technology providers All Phase 0 stages were the different filters the innovation ideas went through when crossing the DECIPHER Innovation Funnel. Thanks to these filters the scope of the PCP programme was reduced just to the three procuring authorities common needs that are still uncovered by the existing technologies and that the industry is willing to deliver within the defined timeframe and sharing risks and benefits as defined in the programme: Figure 2 DECIPHER Innovation Funnel Page 4 of 8
4. Specification of functional / performance-based requirements The Functional specification phase was crucial for the success of the project since its outcome not only determined the next steps to perform to complete Phase 0 (the state of the art analysis in DECIPHER domain, the patent search, business cases and the engagement of the industry players) but also its outcome made part of the tender documentation the bidders used to define their proposals. The methodology used to elicit the functional specifications is called FAST (Functional Analysis System Technique). According to this methodology the basic element of a system is the Function that describes the original intent or purpose that a product, process or service expected to be performed. The description of a Function is restricted to a two words format: Active Verb + Measurable Name. The Verb is used to answer to the question: What does it do? While the Name is used to answer to the question: What does the Verb apply to? (e.g.: record data, maintain data) DECIPHER opted to define each of the functions by means of questions.the use of questions is expected to offer opportunity to bidders to propose their most innovative solutions An example extracted from DECIPHER Challenge Brief could be: The function of Manage Treatments expresses the needs: Q3.1 - How can we increase treatment adherence? Q3.2 - How can we reduce the number of times patients run out of medicines? Q3.3 - How can we ensure treating physician is informed about all the known treatments adverse effects, interactions and intolerances before prescribing new ones? Some of the functionalities to be addressed by DECIPHER Service are: i. Register effects. Patients can report in DECIPHER treatments adverse effects, interactions and intolerances of the prescribed treatments and this report should be sent back to the PA-PHR-S. ii. Register events. Patients are requested to confirm in DECIPHER they follow the treatment schedule. iii. Manage and Send Reminders. Page 5 of 8
Patients are reminded from DECIPHER to follow the treatment. (...) 5. Verification of innovative solutions (either within the tendering process or in precommercial phase) The innovative solution developed during the DECIPHER process will be verified in different ways: During each of the phases the bidders are requested to submit an interim report that indicates the progress made during the phases and is evaluated by the monitoring team, composed by the procuring authorities, external experts and technical experts. The monitoring team will evaluate the interim report and provide recommendations that will have to be taken into consideration by the bidders for the end of phase report. The Expert Board, composed by different members of the monitoring team and including healthcare professionals and patients, will evaluate the end of phase report which is determinant for the bidders to join next phase of the PCP process. During the last phase, the proof of concept, there will be patients and healthcare professionals involved in the validation of the competing solutions. 6. Shared allocation of risks and benefit (including IPR) In co-sponsoring the R&D services between suppliers and the procuring authorities, the latters share the risk inherent to these activities. As a condition of the PCP, the ownership of the IPR generated within the project activities will remain with the Suppliers. However a free licence will be provided to each procuring authority for possible implementation of new proofs of concept and the training of new users (both professionals and patients) in the solutions reached throughout the PCP process. A call-back provision is included in case bidders are not progressing with the exploitation within a maximum of three-year period after the end of the PCP process or are used to the detriment of the public interest behind the DECIPHER PCP at any time. 7. Enable the participation of SMEs One of the main objectives of the project is to support SMEs in their R&D activities by sharing with them the related costs and risks of this investment. The PCP is also a mean by which the procurements are giving Page 6 of 8
access to a potential market for suppliers who would not have had the opportunity without the initial boost in their R&D on innovative solutions. These technological solutions will be closer to market and health procurers will have access to innovative products that has been designed according to their specific requirements, while at the same time entrepreneurs will develop commercially competitive solutions. Given that the exclusion criteria are low-demanding in DECIPHER s call for tender, SMEs can be suitable for the procurement process and come forward with their innovative ideas and work in cooperation with the procuring entities in defining the specifications of the product in accordance with their needs. Partner finding option provided from DECIPHER website & and the possibility to create consortium is regulated within the ITT, allowing SME to joint strength and asset to bid together 8. Enhance the competition during execution and facilitate innovation over the contract period (for PCP multiple sourcing and approach in phases, for PPI performance condition, lots.) The joint PCP will be conducted ensuring that the competition is conducted using an open, fair and transparent tendering process. The DECIPHER PCP Procedure will be divided into four Phases. Each phase will result in a competition between the Bidders in such a way that the number of Bidders will decrease from one Phase to the next one to ensure selecting those that best address the technical challenge on which this PCP is based: Phase 0: Initial Selection.- Any Bidder will be entitled to submit a preliminary innovative solution, for which will receive no payment (no budget nor payments at this stage). Phase 1: Solution Design Selection. A maximum of 9 Bidders awarded with the Phase 1 will be entitled to submit a final design for an innovative solution, for which each Bidder will receive a maximum payment of 25.000 EUR (VAT excluded). Phase 2: Prototype Development Selection.- A maximum of 6 Bidders awarded with the Phase 2 will be entitled to develop prototypes on the basis of the final innovative solutions selected at the end of Phase 1, for which each Bidder will receive a maximum payment of 52.500 EUR (VAT excluded). Phase 3: Proof of Concept.- A maximum of 3 Bidders awarded with the Phase 3 will be entitled to produce and test a small scale products on the basis of the prototypes finally selected at the end of Phase 2, for which each Bidder will receive a maximum payment of 120.000 EUR (VAT excluded). 9. (Identified) Knowledge, skills and resources needed to conduct PCP/PPI DECIPHER consortium did not have significant previous experience in the PCP process. The project is an opportunity the entities involved in developing and testing knowledge, skills and resources necessary for the implementation of innovation procurement and innovation in procurement processes. In the partners organizations, apart from the Innovation department, the legal contract department and end-users, such as healthcare professionals and patients, had to face a new perspective to this innovative approach to technology and services provision. The project management team in the innovation Page 7 of 8
departments, as such were prepared for this approach as part of their tasks, whereas legal and contract departments and end-users came on board as stakeholders within the organizations that required understanding and learning new skills and know-how to tackle a PCP. It is worth mentioning, that expertise in keeping up with the state-of-the-art in m-health and innovation in the health technology mastering were crucial. Better understanding of the business and entrepreneurial contexts and requirements on behalf of the partners is essential. Furthermore, the communication departments had to become familiarized with the concepts involved to effectively disseminate information on the PCP process to all stakeholders, potential bidders and SMEs. 10. Business / service case development- was this present and relevant As from the early stages of the Need Assessment for the 3 procuring authorities, the development of a business case was taken into consideration. During this process, the three regional procurers defined the common needs and benefits. They came to the consensus on 3 benefits that would support investment in DECIPHER: I. Improvement in patients health status and quality of life II. Reduction of healthcare burden through mainly the increase of treatment adherence and the decrease of possible complications of long term conditions III. Increase of mhealth industry market through the adoption of interoperability standards Both the Business Case and the Qualitative business model were defined during the Feasibility Analysis and Concept Viability phase 11. What was the main aim of the procurement? Procure only new technology/solution or technology+ service (service procurement) leading also possibly to change in care model/delivery? The main aim was to procure for a new solution where technology providers were not given preconceptions on whether it should be a technology only or technology+service. Their business model should define how this solution would be sustainable. In any case the ultimate goal is to positively impact the healthcare services delivery thanks to the technology provided and the bidders business model should take into account this change in the service. 12. Procurement results was it worth the investment in the pre-procurement phase? At this stage, it is too early to draw a definitive conclusion, so far the learning process has been enriching for our consortium. 13. Main lessons learnt in general As above, at this stage it is too early to make such analysis. Page 8 of 8