EMpowering PAtients for a beTTer Information and improvement of the Communication Systems (EMPATTICS)
1. GENERAL CONTEXT
1.1. Introduction to pre-commercial public procurement
The EMPATTICS project is a pre-commercial procurement (PCP) co-fund action of the Horizon 2020 programme built upon an international partnership formed by 8 entities from 5 different European countries: Spain, Denmark, France, United Kingdom and Ireland.
EMPATTICS aims to find Health Information Technology solutions which meet the needs of providers and consumers in improving the effectiveness of self-management of common chronic diseases. They should be solutions which can be adapted to provide a valuable adjunct for all three chronic disease groups chosen by EMPATTICS, i.e., diabetes, COPD and heart failure, but the EMPATTICS consortium also expects that they may subsequently have wider application.
The three selected diseases in the EMPATTICS project represent a major challenge for health systems across Europe, moving around 163 billion euros in direct costs. The three diseases also impact on the wider social systems and economies of Member States which call for adequate prevention and sustainable disease management technologies.
The combination of the group of services into one technology should represent major savings for health systems across Europe and, at the same time, a huge business opportunity for European companies.
The proposed solutions aim to cover a technology gap identified in the e-health sector across Europe. Despite the extensive deployment of chronic patient management technologies, few of them have reached an effective interaction with the patient and its further integration with other systems, such as, for instance, EMR.
The system and the R&D demanded in this PCP must be highly focused on the interaction with patients, being capable of gathering and providing information through user-friendly and intelligent intercommunication technologies.
Pre-commercial public procurement (PCP) is a procedure for competitive public procurement which enables public procurers to develop innovative solutions that cover the needs of the public sector and the challenges facing it.
PCP means that public procurers challenge innovative companies on the market, via an open, transparent and competitive process, to develop new solutions for a technologically demanding mid- to long-term challenge that is in the public interest and requires new R&D services. PCP fosters innovation and creativity through a public procurement procedure organised in phases to reduce the level of potential risk during the different development phases.
PCP is explained in the PCP communication COM/2007/7991 and the associated staff working document SEC/2007/16682 to:
Share the risks and benefits from designing and developing prototypes and testing new solutions.
Create optimal conditions for large-scale commercialisation and the implementation of the products and services with suppliers and other stakeholders (e.g. end users).
Coordinate the efforts of several purchasers to achieve common objectives within the existing legal framework, thereby providing opportunities for the development of different ideas at the same time. These solutions may finally be acquired through joint public commercial procurement, in accordance with existing Directives on Public Procurement.
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PCP is outside the scope of application of the EU Directive 2014/24/EU on procurement procedures3 whose article 14 states that the Directive “shall only apply to public service contracts for research and development which are covered by CPV codes 73000000-2 to 73120000-9, 73300000-5, 73420000-2 and 73430000-5 provided that both of the following conditions are fulfilled:
a) The benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, and
b) The service provided is wholly remunerated by the contracting authority.”
In line with this provision, the Spanish legislation on public procurement4 also excludes PCP from its scope of application.
Given these considerations, the exclusion of PCP from the scope of application of the Directive 2014/24/EU and the Spanish legislation on public procurement requires:
R&D services to be awarded.
Risk-benefit sharing between the public purchaser and the R&D service providers, with sharing of Intellectual Property Rights5.
A competitive procurement designed to exclude state aid, which means that the PCP R&D services have to be remunerated at market prices.
Essentially, PCP involves the definition of a challenge that cannot be satisfied with current technologies. Public procurers communicate this challenge to the market, which attempts to respond through and open, transparent and competitive process to the unmet challenge, providing several solutions, technologies and innovation approaches. PCP facilitates the execution of the most promising R&D projects through a methodology characterised by the following four features:
Competitive development in phases to identify the solutions offering the best value for money
PCP targets situations that require radical innovation or R&D and for which there are typically no solutions on or close to the market yet. Different competing providers may have different ideas for solutions to the problem. As R&D is yet to take place, there is not yet any proof as to which of these potential alternative solutions would best meet customers' needs.
PCP therefore awards R&D contracts to a number of competing contractors at the same time, in order to compare different approaches to solving the problem. It thus offers innovators an opportunity to show how well their solution compares with others. It also allows a first customer test reference to be obtained from countries of the procurers that will test the solutions.
The R&D is split into three phases (solution design, prototyping, original development and testing of a limited set of ‘first’ products or services). Evaluations after each phase progressively identify the solutions that offer the best value for money and meet the costumers’ needs. This phased approach allows successful contractors to improve their offers for the next phase based on lessons learnt and feedback from procurers in previous phase. Using a phased approach with gradually growing contract sizes per phase also makes it easier for smaller companies to participate in the PCP and enables SMEs to grow their business step-by-step with each phase.
Depending on the outcome of the PCP, procurers may or may not decide to follow-up the PCP with a public procurement to deploy the innovative solutions (PPI).
Public Procurement of R&D Services
PCP addresses mid- to long-term public procurement needs for which either no commercially stable solutions yet exist on the market, or existing solutions exhibit structural shortcomings that require further R&D to resolve. PCP is a way for procurers to trigger the market to develop new solutions which address these shortcomings. PCP focuses on specific identified needs and provides customer feedback to businesses from the early stages of R&D. This improves the likelihood of commercial exploitation of the newly developed solutions.
The R&D services can cover research and development activities ranging from solution exploration and design of very early technologies, to prototyping in an operational environment or even to the development of a limited set of 'first' products or services in the form of a test series. Original development of a first product or service may include limited production or supply in order to incorporate the results of field testing and demonstrate that the product or service is suitable for production or supply in quantity to acceptable quality standards. R&D does not include quantity production or supply to establish the commercial viability or to recover R&D costs6. PCP also excludes commercial development activities, such as incremental adaptations or routine or periodic changes to existing products, services, production lines, processes or other operations in progress, even if such changes may constitute improvements.
Open, transparent, non-discriminatory approach — No large-scale deployments
PCP is open to all operators on equal terms, regardless of the size, geographical location or governance structure. There is, however, a place of performance requirement that they must perform a predefined minimum percentage of the contracted R&D services in EU Member States or Horizon 2020 associated countries.
Any subsequent public procurement of innovative solutions (PPI), for the supply of commercial volumes of the solutions, will be carried out under a separate procurement procedure. Providers that did not take part in this PCP (or were not chosen to go through as far as the last phase) will thus still be able to compete on an equal basis in any subsDRAF equent procurement looking for contractors to provide a solution on a commercial scale.
Sharing of IPR-related risks and benefits under market conditions
PCP procures R&D services at market price, thus providing contractors with a transparent, competitive and reliable source of financing for the early stages of their research and development. Giving each contractor the ownership of the IPRs attached to the results it generates during the PCP means that they can widely exploit the newly developed solutions commercially. In return, the tendered price must contain a financial compensations for keeping the IPR ownership compared to the case where the IPRs would be transferred to the procurers (the tendered price must be the 'non- exclusive development price'; see section 4.5.4). Moreover, the procurers must receive rights to use the R&D results for internal use and licensing rights subject to certain conditions.
For more Information, see PCP on the Europa website7.
1.2. Exemption from EU procurement directives, the WTO Government Procurement Agreement (GPA) and EU State aid rules
As stated above, this procurement procedure is exempt from the EU public procurement directives
as procurers do not retain all the benefits of the R&D (as a general rule, the IPR ownership remains with the contractors)8.
PCP is also exempted from the WTO Government Procurement Agreement (GPA) because this Agreement does not cover R&D services9 (the PCP being limited to such services — and any subsequent PPI or similar large-scale innovative procurements activities relating to commercial-scale supply of such solutions not being part of the PCP procurement).
The procurement does not constitute state aid under the EU state aid rules10 because it follows an open, transparent, competitive procedure with risk- and benefit-sharing at market price. (The division of all rights and obligations (including IPRs) and all selection and award criteria for all phases are published at the outset; the PCP is limited to R&D services and clearly separated from any potential follow-up PPI procurements; PCP contractors are not given any preferential treatment in a subsequent procurement for provision of the final products or services on a commercial scale).
1.3. EU funding
This PCP procurement is part of a project that is funded by the European Union's Horizon 2020 Research and Innovation Programme, under grant agreement No 690492 — EMPATTICS (see http://empattics.eu/).
The procurement must therefore comply with the rules imposed by the EU Horizon 2020 grant
agreement. PCP H2020 co-fund actions11 aim to encourage the public procurement of research,
development and the validation of new solutions that can bring significant quality and efficiency improvements in areas of public interest, whilst opening up market opportunities for industry and researchers active in Europe. A PCP co-fund action provides EU co-funding for a group of procurers ('buyers group') to undertake together one joint PCP procurement, so that there is one joint call for tender, one joint evaluation of offers, and a lead procurer awarding the R&D service contracts in the name and on behalf of the buyers group.
Each procurer in the buyers group contributes its individual financial contribution to the total budget necessary to jointly finance the PCP, enabling the procurers to share the costs of procuring R&D services from a number of providers and comparing together the merits of alternative solution ways to address the common challenge. Cross-border PCP cooperation should aim to better address issues of common European interest, for example where interoperability and the coherence of solutions across borders is required.
The following organisations comprise the Buyers Group:
Galician Health Knowledge Agency (ACIS)12, the lead procurer
Central Denmark Region (CDR)
Servicio Aragonés de la Salud (SALUD)
GCS Service Numérique de Santé (SESAN)
For more information, see ‘Innovation procurement’ and ‘links to regional policy’ in the Participant Portal Online Manual14.
Attention: The EU is not participating as a contracting authority in this procurement.
1.4. Overview: contracting, budget and schedule
The EMPATTICS project started on 1 February 2016 and will end on 31 December 2019.
Grant Agreement number: Project Coordinator: Project dates:
EMpowering PAtients for a beTTer Information and improvement of the Communication Systems
Galician Health Knowledge Agency (ACIS)
From 01/02/2016 to 31/12/2019
EU contribution will be limited to maximum 70% of the total
eligible costs www.empattics.eu
1.4.1. Total budget and budget distribution (per phase)
The total maximum budget for this PCP is 2,800,000.00 euros.
The maximum duration per phase, the minimum number of contractors that are expected to be selected per phase, the maximum budget per phase and the maximum budget per bidder (including VAT and other taxes and duties that may be applicable to the supplier) are given in the table below:
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EMPATTICS is focused on the goal of transforming current relationship and care models between providers, professionals and patients and on the creation of a safe, fast and intelligent patient- centred healthcare system. The project seeks highly innovative solutions that are not available in the market through three different phases. The numbers of bidders involved and retained will differ in each phase.
Phase 1: Phase 1 contracts will be for 5 months and a minimum of 6 bidders will be appointed, with awards of up to 41,666.67 euros (including VAT and other taxes and duties that may be applicable to the supplier) against a total budget of 250,000.00 euros. Phase 1 aims to verify the feasibility proposed by bidders. It also aims to achieve a good understanding of the impact of such technologies, not only on health organisations but also on the e-health market. The expected output of phase 1 is detailed in section 3.4. Phase duration and main activities are detailed in section 1.4.3.
Phase 2: Phase 2 contracts will be for 9 months and a minimum of 4 bidders will be appointed,
with awards of up to 250,000.00 euros (including VAT and other taxes and duties that may be
applicable to the supplier) against a total budget of 1,000,000.00 euros. Phase 2 aims to develop
and verify the main features exhibited by a technology prototype. Expected outcomes involve a
prototype specification and initial demonstration, as well as a plan for limited first product development, involvement of both healthcare professionals and patients, and, above all, a detailed field testing plan for phase 3 (including all the necessary requirements and certificates for field testing activities). The expected output of phase 2 is detailed in section 3.4 and phase duration and the principal activities are detailed in section 1.4.3.
Phase 3: Phase 3 contracts will be for 9 months and a minimum of 3 bidders will be appointed, with awards of up to 516,666.66 euros (including VAT and other taxes and duties that may be applicable to the supplier) against a total budget of 1,550,000.00 euros. In this phase, original development of a first batch of devices/technologies will be developed and subsequently evaluated through field tests. Phase 3 aims to verify and compare technology performance in real scenarios involving patients and healthcare professionals. The main output of this phase includes a test of technology that should provide evidence of its impact and benefits on both quantitative and qualitative measures. The required R&D services will end here with a report on the field testing activities conducted by each contractor at the different test sites. The expected output and duration of phase 3 are detailed in section 3.4 and 1.4.3, respectively.
In the event of the above-mentioned minimum number of bidders for each phase not being reached, the contracting authority may decide to continue with the PCP procedure providing that there are a minimum of two initial tenders and that the principle of competitive development in phases is guaranteed.
The contracting authority may transfer leftover budget from one phase to the next phase if bidders present offers with prices lower than expected.
For phases 1 and 2, contracts are funded until the remaining budget is insufficient to fund the next best tender. The exact number of contracts finally awarded will thus depend on the prices offered and the number of tenders passing the evaluation. As leftover budget from the previous phase will be transferred to the next phase, the total budget available for phases 2 and 3 may eventually be higher than stated herein (but the maximum budget per contractor for phases 2 and 3 will remain the same). The lower the average price of tenders, the more contracts can be awarded. The total value of the contracts awarded can also be lower than initially expected if there are fewer tenders than expected that meet the minimum evaluation criteria.
1.4.2. Contracting approach
The PCP is implemented by means of a framework agreement with specific contracts for each of the R&D phases (altogether 'contracts').
Research is defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. In the EMPATTICS PCP the Research and Development (R&D) will focus on the interaction of the new system with chronic patients. The new solution must gather and provide valuable information through a friendly, automatically and intelligent technology. The solutions must also be deployed and tested with patients in their own environment. With reference to the Deliverables set out in section 3.4, it is important to know that knowledge will build up across the phases, so that the solution is defined in Phase 1, a full working prototype is operational in Phase 2 and then field trials to test in Phase 3.
Following the tendering stage, a framework agreeDRAF ment and a specific contract for phase 1 are expected to be awarded to a minimum of six contractors. At the beginning of phase 1, contractors will receive specific guidelines to help them to prepare the field testing plan and the implementation of field testing activities in the buyers regions. In these guidelines, the EMPATTICS buyers must provide a list of the professionals selected in each region for patient recruitment during the field testing phase. Moreover these guidelines will also contain details and relevant information about resources for conducting clinical trials in each region and how to design a technology-tailored Data Management Plan in each buyer region. To avoid any doubt, the preparation of field testing plans and the implementation of field testing activities are the responsibility of contractors, except for patient recruitment, which will be conducted in collaboration with the buyers.
Although the official language of EMPATTICS is English (see section 4.7.3), contractors should be able to interact with local bodies, health professionals and patients in their national language (Spanish, Danish and French). Adaptation to local languages is necessary to guarantee appropriate co-creation and co-design activities. This interaction with regional stakeholders in national languages will be extended to phases 2 and 3.
A call-off will be organised for phase 2, with the aim of awarding a minimum of four phase 2 contracts. Only offers from contractors that have successfully completed phase 1 will be eligible for phase 2. In phase 3, contractors will test the phase 2 prototypes in buyers regions. However, the EMPATTICS Buyers Evaluation Board (BEB) will undertake an assessment of the final prototypes at the end of phase 2. It should be noted that the prototypes are expected to be fully operational for testing by the end of phase 2.
As part of phase 2 activities, contractors will be expected to plan field trials and seek approval
through the local ethics and research bodies.
A second call-off will be organised for phase 3, with the aim of awarding a minimum of three phase 3 contracts. Only offers from contractors that have successfully completed phase 2 will be eligible for phase 3. Phase 3 field testing is expected to take place in the four buyer regions (Galicia, Aragón, Central Denmark Region and Île-de-France). However, due to unpredictable circumstances, the number of regions may be reduced with prior notice from the lead contractor. In this event, contractors will be notified before the beginning of phase 3 and the total budget for this third phase will be amended accordingly, as set out in Section 4.7.4 of this Call for tender.
The framework agreement sets all the framework conditions for the entire duration of the PCP (covering all the phases). There will be no renegotiation. The framework agreement remains binding for the duration of all phases for which contractors remain in the PCP. Bidders that are awarded a framework agreement will also be awarded a specific contract for phase 1 (evaluation of tenders for the framework agreement and phase 1 are combined). Bidders are therefore asked not only to submit their detailed offer for phase 1 in their tender, but also to state their goals, and to outline their plans (including price conditions) for phases 2 and 3, thus giving specific details of the steps that would lead to commercial exploitation of the R&D results.
A brief overview of the overall timing of the PCP (including the expected start and end dates) and of the individual phases is as follows:
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2. PROCURERS AND OTHER PARTIES IN THIS PCP
2.1. The EMPATTICS Buyers Group and other parties involved 2.1.1. The EMPATTICS Lead Procurer
This procurement relates to a joint PCP that will be carried out by the following lead procurer: the Galician Health Knowledge Agency (ACIS).
The Galician Health knowledge Agency is a Public Body attached to the Galician Regional Health Ministry16. Its offices are at Avda. Fernando de Casas Novoa 37, Portal A-B, 1st floor, Santiago de Compostela 15707, Spain.
EMPATTICS LEAD PROCURER
Internet address of the Lead procurer:
(+34) 981 568 072
The Lead Procurer is the EU grant Beneficiary that represents the buyers group for the funded procurement and is also part of the 'buyers group' as it contributes to the PCP procurement budget.
2.1.2. The EMPATTICS Buyers Group
ACIS, as lead procurer and member of the buyers group, has been appointed to coordinate and lead the joint PCP, as well as to sign and award the framework agreement and the specific contracts for all phases of the PCP, in the name and on behalf of the EMPATTICS buyers group:
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The procurers in the buyers group have the following background/profile:
1. Galician Health Knowledge Agency, ACIS: ACIS is a public agency created to become the chief
element of the health knowledge and innovation ecosystem in Galicia, a Spanish Autonomous Community located in the Northwest of the Iberian Peninsula and whose population is close to three million people. ACIS assumes the innovation responsibilities of the Galician Health Ministry and of SERGAS17.The main resources of SERGAS, with an annual budget of 3,400 million euros, consist of 7 hospital trusts with tertiary care services, and 7 rural hospitals with secondary care services. A further 460 primary care centres and around 36,000 professionals complete the network of healthcare facilities in the Region. The public health authority and the public healthcare provider work in close collaboration towards the goal of providing sustainable healthcare services with the highest levels of quality. The population covered by the SERGAS reaches 2.68 million people18, of whom 24% are people over the age of 65. Accordingly, several policy commitments have been developed in line with this singularity in Galicia. Firstly, one of the objectives of the SERGAS 2020 Strategy is to promote health and respond to the needs of the citizens, with one of the challenges being the reorientation of chronic disease management towards an integrated management giving rise to better clinical results, adherence to treatments, responsibility of patients with their illness and improvement of the quality of life. Secondly the Priorities Plan gathers the most relevant chronic diseases in Galicia and the improvement actions that are necessary in each one of them. Moreover, the third challenge of the Galician RIS3, “New healthy lifestyle model based on active ageing of population” which will position Galicia in 2020 as a lead region in Southern Europe offering knowledge, products and services linked to a healthy lifestyles model. Additionally, Galicia is a three-star Reference Site for the EIP on AHA, which confirms its commitment to an innovation-based approach to active and
Central Denmark Region, CDR: CDR is one of five administrative regional units in Denmark. The primary responsibility of Central Denmark Region is healthcare, involving responsibility for hospital services (5 hospitals), including psychiatry (1 hospital and more specialised institutions), health insurance, general practitioners (835 general practitioners in around 475 practices) and specialists. In addition the region operates a number of social institutions. Around 30,000 employees work to carry out regional tasks at all levels. The population in CDR amounts to 1.3 million and the annual healthcare budget is 3,350 million euros. Central Denmark Region is actively working with healthcare solutions that revolve around the patient, including patient involvement and empowerment. All hospitals have 100% implementation of a shared EMR (Electronic Medical Record). Central Denmark Region prioritises healthcare innovation in combination with business development and has vast and relevant experience with Public- Private innovation. The Regional Department of Procurement & Clinical Engineering has a constant focus on improving a value adding and transparent dialogue in procurement – both innovative and traditional. CDR has 1.3 million inhabitants served by the public healthcare services19. Empowerment of patients and supporting their self-management capabilities is part of the Strategy for Health Care (2016 – 2019) in CDR. One of the pillars in the Health Care plan is to involve the patients in decisions concerning their care plan and treatment. Some of the initiatives are to develop and deploy user-friendly IT solutions that can help patients to achieve their own goals; e.g., regarding what to eat, adhering to an exercise plan and taking their prescribed medication. Furthermore, CDR aims to provide patients with access to their own data and knowledge of how to react to different physical symptoms and trends in their data.
Servicio Aragonés de la Salud, SALUD: SALUD isDRAF the public healthcare provider for the region of Aragón (Spain), being responsible for the overall management and coordination of the existing healthcare resources in the territory. It provides healthcare services for Primary care, Secondary care, mental care and geriatric care management, including homecare, and the promotion and protection of individual and public health. SALUD's mission is to provide integral healthcare attention, to ensure service accessibility, to promote healthy lifestyles, prevention and protection and to maintain patients' autonomy and their social inclusion. SALUD has a network composed of 12 General Hospitals, 110 Primary Health Centres and 5 Geriatric hospitals, and an annual budget of 1,700 million euros. It has introduced innovation on the professionals' regular practice through the integration of telemedicine solutions thanks to collaboration in several strategic projects. SALUD provides healthcare services to the entire population of Aragón, which in January 2016 was 1,308,563 inhabitants20. Aragón’s promotion of chronic care has been visible through several initiatives, such as the Government of Aragon’s “Information Systems and Telemedicine Plan”, the “Strategic Plan for Aragón Social Services 2012-2015”, the “Aragón Social Law”, and “the Strategy for Chronic Care” among others. The Aragón government is also involved in the development of a set of specific actions to improve the care of chronic patients, which is to be deployed over the coming months.
GCS Service Numérique de Santé, SESAN: founded in 2008, SESAN is a healthcare cooperation consortium, which aims to develop the shared health information systems within the Île-de- France region, which has more than 12 million habitants. SESAN is in charge of building the e- health domain. The target is the regional health cyberspace, called ENRS. This ENRS (Health Regional Digital Space) is defined as computerised services and applications undertaken by the health regional Agency (ARS) and piloted by SESAN. It is compliant with the interoperability framework and the national methods promoted by the national health information Agency (ASIP Santé). It meets the objectives defined by the national and regional health policies. SESAN is composed of 8 colleges of members who represent all the health organisations and GPs in the region.
EMPATTICS BUYER GROUP RESPONSIBILITIES
Galician Health Knowledge Agency, ACIS
PCP contract execution and implementation. Coordination of the entire project. Evaluation of bidders and contractors as member of the Buyer Evaluation Board. Support for Phase 3 field testing in Galicia, Spain
Central Denmark Region, CDR
Open Market Consultation coordination. Evaluation of bidders and contractors as member of the Buyer Evaluation Board. Support for Phase 3 field testing in Central Denmark Region, Denmark
Servicio Aragonés de la Salud, SALUD
General Field testing coordination. Evaluation of bidders and contractors as member of the Buyer Evaluation Board. Support for Phase 3 field testing in Aragón, Spain
GCS Service Numérique de Santé, SESAN
Evaluation of bidders and contractors as member of the Buyer Evaluation Board. Support for PhaseDRAF 3 field testing in Île-de-France, France.
3. DESCRIPTION OF SERVICES TO BE PROCURED
3.1. Motivation for the PCP
Chronic diseases are the leading cause of illness and disability in Europe today. Over 100 million citizens over the age of 15 (40% of European population) are reported to have a chronic disease21.
It is widely acknowledged that 70–80% of health care costs are spent on chronic diseases. This corresponds to €700 billion in the European Union, and this number is expected to rise in the coming years21.
In a context of ageing populations and growing incidence of chronic diseases, different countries are now seeking ways to shift resources into the community in an effort to deal more effectively with chronic conditions. In particular, they are looking for ways to empower people to manage their own health and healthcare, by providing them with effective self-management support22.
In recent years, an important number of initiatives have emerged to develop applications to support
self-management in chronic conditions, most of them addressing patients directly and being
substantially less driven by buyers. For that reason, many of the technologies available in the
market do not properly cover the population’s needs in a comprehensive way and are not designed
to support shared decision making and communication between patients and health professionals,
and only few are integrated into the Electronic Medical Record Systems of Public Health
Authorities. This lack of data-sharing possibilities limits the capacity of clinicians to follow up on patient’s behaviours, and support self-management initiatives.
EMPATTICS buyers have in some way demonstrated a broad deployment of technologies for chronic patient management, but they also recognise the absence of effective, automatic, intelligent and reactive technologies covering all the needs that will be outlined in the following sections, and also based on international IT standards, in such a way that they can be easily integrated with the ICT tools available in each Public Health Service of the EMPATTICS consortium, or at least allowing some of the output data to be easily transferred to the EMRs and/or other available ICT tools. They have already been working on the development of patient empowerment and self-management e-health solutions/services and have experience in the advantages and shortcomings of this effort. The buyer regions have also reached a high level of efficiency in drugs and diagnostic technologies; nonetheless, many patients across Europe unfortunately do not receive enough support for their treatment and healthy lifestyle recommendations, or do not receive adequate information and do not have access to decision support tools. EMPATTICS aims to address these factors by increasing the empowerment of patients as well as their adherence to their care plan.
Firstly, the impact of patient empowerment on health outcomes and on health expenditure has already been evaluated through several initiatives (many of them outside Europe). Despite the fact that not all the studies on this field have been to demonstrate the relation between the patient activation and the engagement in preventive behaviours, treatment and healthy lifestyle, most of the studies claim this sort of relation. For instance, one study based on data from the EHR of more than 20,000 patients23 states that for every additional 10 points in patient activation, measured through the PAM questionnaire, the predicted probability of being obese, having an emergency visit or smoking is one percentage point lower, and the probability of having clinical indicators (A1c, HDL and triglycerides) in the normal range is one point lower. Nevertheless, literature evidences that patient empowerment does not only impact on clinical outcomes but also on user experience and on healthcare costs. The costs of lack of patient activation or limited health literacy have been estimated by one study to be between 3 and 5% of the total health care cost per year24. Another study25 with a sample of more than 30,000 patients estimated that patients with the lowest activation levels had predicted average costs that were 8% higher in the base year and 21% higher in the first half of the next year than the costs of patients with the highest activation levels. According to the Insignia Health website26, each single point in PAM score correlates to a 2% decrease in hospitalisation and 2% increase in medication adherence. Impact on health outcomes and on expenditure is studied not only on the short but also on the medium term, with similar results27.
Secondly, there are many studies which unequivocally point towards lower compliance or
adherence, the poorer the outcome and the less cost-effective treatments become. Moreover, non- adherence is accompanied with increased hospitalisations and readmissions as well as healthcare expenditures. All these are more significant in patients suffering chronic diseases and the majority of them being avoidable. All of this represents a major challenge, in a context in which public administrations are adopting specific expenditure distribution methods, with the aim of guaranteeing access, quality and sustainability of the health system. In order to improve their adherence, patients must acquire an active role in the management of their disease and increase their autonomy and their capacity for self-management. In addition, it is essential that there should be a relationship with their healthcare professionals based on dialogue and trust, facilitating patient participation in decision making.
Although there are many studies that relate non-adherence to a decrease in patients’ quality of life and life expectancy and the appearance of a greater number of complications, which often results in a higher expenditure, EMPATTICS has chosen the study conducted by Farmaindustria28 in collaboration with different health entities and patient associations in Spain to state the economic impact of adherence in the three diseases chosen for the project scope (diabetes, COPD and heart failure). According to this analysis, increasing one point in the average level of non-adherent patients would result in avoiding:
- Direct healthcare expenditure of more than 1,316 million euros in addition to more than 5,400 events avoided for diabetes over a 20-year horizon.
- Direct healthcare expenditure of more than 8.5 million euros in addition to 1,089 deaths and more than 20,000 exacerbations for COPD over a 2 year horizon.
- Direct healthcare expenditure of more than 11 million euros in addition to 1,200 deaths and more than 1,100 events avoided for heart failure over a 15 year horizon.
For the EMPATTICS group there is clear rationale from the above data suggesting that an increase in efficiency (resources consumption and thus direct cost) and also quality (patients ́ clinical outcomes) can be reached by providing chronic-disease patients with new ways to support their empowerment and adherence to their care plans.
The EMPATTICS Buyers regions healthcare providers are responsible for around 6 million people suffering from chronic diseases whose quality of life can be positively influenced by the solutions developed under this project. It has been calculated that more than 5,800 million euros are spent annually on chronic diseases in Galicia, Aragon and CDR alone. Considering data on the cost of patients' activation levels25 (8% the base year and 21% the first half of the year) and data on the cost of adherence, a potential reduction in expenditure of 10% could be easily expected, thus 580 million euros a year could be saved in these regions.
This explains why the EMPATTICS consortium aims to develop new health information technology solutions, with a view to overcoming the main gaps identified in current technologies and promoting more efficient support and disease management for patients.
Diseases selected to test the developed solution
To identify those chronic diseases and conditions that could be used most effectively as a demonstration through the procurement process, a discussion and agreement process was carried out among the buyers. This process was based on the expert knowledge and analysis of previous evidence from the WP-members and buyers’ experience and interest and their perspective on achieving greater impact in their region.
The variables that were considered to select the diseases were: prevalence of the disease/condition in each region; the disease burden, including morbidity and mortality; economic impact, including cost and consumption of resources; and potential benefit of ICT in self-management.
Three chronic diseases have been chosen to test the solution developed during the PCP: diabetes, COPD (Chronic Obstructive Pulmonary Disease) and heart failure, although it is expected that it may subsequently have a wider field of application.
Note: more information on selected diseases, their incidence and the ICT solutions available in each buyer region can be found on the EMPATTICS website.
Common definitions for EMPATTICS project
The empowerment of patients to support the patients ́ adherence and minimise non-adherence is a key goal of the EMPATTICS project. For the purposes of the project and this document, the definitions of adherence and empowerment, which have been adopted from previous European research projects29, are as follows:
A) Adherence is defined as the level to which patient behaviour coincides with a treatment plan that has been mutually agreed with healthcare professionals. This includes lifestyle factors, such as diet, and physical activity. Of the utmost importance, however, is the adherence to medication – a sine qua non condition of positive outcomes30.
B) Empowered patients have control over the management of their condition in daily life. They take action(s) to the extent that they wish to do so, to improve the quality of their life and have the necessary knowledge, skills, attitudes and self-awareness to adjust their behaviour and to work in partnership with others, where necessary, to achieve optimal well-being.
C) Empowerment interventions aim to equip patients (and their caregivers, whenever appropriate) with the capacity to participate in decisions related to their condition to the extent that they wish to do so; to become ‘co-managers’ of their condition in partnership with health professionals; and to develop the self-confidence, self-esteem and coping skills to manage the physical, emotional and social impacts of their condition/s in everyday life.
As this definition illustrates, a central key element of patient empowerment is related to the actions that patients take in their day to day life; i.e., in self-management. For the purposes of EMPATTICS, self-management is considered as:
A) The naturalistic decision-making process that individuals use in the choice of behaviours that maintainphysiologicalstability(symptom(s)mDRAFonitoringandtreatmentadherence)andthe response to symptoms when they occur in the context of their own health status.
B) The term self-management of long-term conditions, refers to the tasks a person can perform to minimise the impact of that illness on his/her health status by him/herself, or with the support of a healthcare provider. In practice, the self-management of a long term condition requires that a person has the skills to self-monitor the symptoms and clinical markers of those conditions, to understand the associated implications, and to adjust medication, treatment or behaviour accordingly.
Additionally, it is important to stress that the EMPATTICS project is guided by a patient centred-care approach, defined as:
Healthcare that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients’ wants, needs, and preferences, and that patients have the education and support they need to make decisions and participate in their own care31.
This concept involves the need to count on the patient perspective in any element of the care process (including care process design and clinical decisions).
For the purpose of this document and the EMPATTICS project, we will use the concept of Self- management Health Information Technology referred to patient-focused, technology-mediated applications and/or devices that are designed to enable patients to engage in self-management activities such as health sign and symptom monitoring, medication adherence, emotional management, self-education, and information exchange and communication to promote their health and well-being32.
3.2. Preparation for the PCP
The preparation for the EMPATTICS PCP call for tender involved many different activities related to the identification of the buyer needs, reporting on the market scope and the development of an Open Market Consultation.
The needs assessment was performed considering two perspectives: collecting the evidence about the effectiveness of the Health Information Technology (HIT) and analysing the main needs of the stakeholders in each region (considering healthcare data, and qualitative information from healthcare professionals and patients).
The literature review was performed with an overview of systematic reviews of ICT in self- management interventions. The overview analysed ‘high quality’ systematic reviews encompassing over 1,300 original studies and over 79,000 patients. Complementing the effectiveness of the ICT interventions, European initiatives, key documents and qualitative information was collected to identify barriers and facilitators that may help or hinder its implementation. Many of the conclusions of this report have been used to define the common health challenge.
Based on the results of these steps, the regional strategic needs assessment was conducted, combining a review of socio-economic data and focus groups carried out in the participating regions with patients and professionals. These focus groups were organised around two main questions: "which aspects or characteristics might be a barrier to engagement by patients with self- management ICT tools?" and "what kind of changes could be made to facilitate the adoption of ICT- based self-management tools for patients with chronic diseases?" The principal results from these focus groups were a set of barriers and a set of functional requirements. The list of barriers were also transformed into functional requirements with a view to bringing together all the inputs from the focus group with end-users and being particularly sensitive with the statements from the patients. The functional requirements that resulted from this process have been included in section 3.3 of this document.
In short, four perspectives of needs have been identified and these are outlined below. From the patient’s perspective, the summary identifies areas that are important in terms of HIT solutions. It also identifies conditions /situations of reluctance shown on the part of patients.
a) From the patient’s perspective
Considering patient awareness and personalised education: Patients have expressed their need to receive more accessible and reliable information about changes to their disease, treatment, lifestyle and behaviours. It is also important for patients to receive help in dealing with the potential information overload in order to achieve a personalised focus on their main needs and priorities. HIT is seen as a potential solution for covering this need in consideration of specific patient circumstances.
Considering specific context and patient circumstances: Although all the target patient groups have chronic diseases, individuals may have very different needs and priorities, depending on their social context, level of coping, disease stage, severity, multimorbidity or other characteristics (such as cognitive deterioration) that are relevant for achieving appropriate self- management. This overview of their circumstances could include patients who are simply unable or unwilling to self-manage their disease: these groups should also be recognised and have tailored plans developed for them.
Considering patient health literacy and digital competence: Patients have different levels of
health literacy (‘the degree to which individuals have the capacity to obtain, process, and
understand basic health information and services needed to make appropriate health decisions’33
and digital competence (‘Digital competence involves the confident and critical use of information
Society technology (IST) for work, leisure, learning and communication. It is underpinned by basic
skills in ICT: the use of computers to retrieve, access, store, produce, present and exchange
information, and to communicate and participate in collaborative networks via the Internet’34.
These two components (health literacy and digital competence) should be addressed by the HIT solutions, while recognising that the professionals concerned may also have varying levels of digital competence.
This aspect of needs might involve patients who are reluctant to use HIT solutions. Therefore, one size does not fit all and traditional face-to-face interactions or less intensive HIT solutions would be more appropriate interventions to encourage self-management for this group.
Supporting self-management and the development of healthy adaptive behaviours (including coping strategies and increased self-efficacy): Patients with chronic conditions make day-to-day decisions; i.e., they self-manage their illnesses. Self-management complements traditional patient education by supporting patients in experiencing the best possible quality of life with their chronic condition and to develop joint plans with those professionals who will help the patients to achieve their goals.
Facilitating and promoting self-monitoring. In order to create disease awareness and acceptance, but also to enable autonomous solving of problems and achievement of agreed goals, patients need to include self-monitoring practices in their daily routine. For this self- monitoring to be effective, the actions to be taken by the patients should be easy to sustain, not too time consuming, and be experienced as supporting the decision-making process.
b) From the healthcare professional’s perspective
Promoting awareness and acceptance of the change of paradigm from a paternalistic model to a collaborative model. A central concept in self-management is self-efficacy (i.e., the ‘confidence to carry out a behaviour necessary to reach a desired goal’35), where self-care behaviours are introduced through internal motivation (rather than through external incentives). Healthcare professionals need to introduce this new chronic disease paradigm: the patient-professional partnership, a model involving a greater degree of collaborative care and more self-management education.
Healthcare professionals need to have timely access to patient information in order to follow- up and provide feedback in accordance with patient status and intensity of support required and to identify causes to help adjust strategies where patients are failing to meet their goals.
Healthcare professionals need more training in technological issues and solutions.
Healthcare professionals need to be able to clearly identify the added value of a particular HIT solution in terms of both patient outcomes and resource considerations, such as time and effort saved through use of the HIT, new information and/or functionalities (thanks to, for example, the introduction of algorithms, help with clinical decisions, etc.).
c) From both the patient and healthcare professional’s perspectives:
Ensuring and promoting patient-healthcare professional communication: Patients have expressed their concerns about keeping in contact with healthcare providers and/or peers/experts in line with their expectations and/or needs. This communication could involve professional support for action strategies (e.g. initiation of antibiotics for COPD patients) or coping strategies.
In addition, healthcare professionals/patients peers need to have easy access to patients suitable for the later status or coping level.
d) For ICT support:
Sustainability: ICT support should cover patients’ needs in terms of length and intensity of the
support and eventually provide longer term support if required.
Interoperability and data integration: ICT support needs to consider current technology developments in each of the participating regions and demonstrate flexibility and capacity, for instance, by using international IT standards and architecture.
Personalisation and modularity: ICT support involves covering, and being attractive to and useful for different typologies of patients and scenarios (see point a) from the patient’s perspective.
Scalability: ICT support needs to be successfully implemented for a significant number of users (patients, carers and healthcare professionals or peers – as expert patients-) and pathologies.
Regarding the market scope, research was undertaken on global best practice tools, current products
and solutions and their limitations, in order to eventually provide information in the definition of detailed specifications for the pre-commercial procurement exercise (see Market Scope Appendix on the EMPATTICS web site).
The activity in the field related to the EMPATTICS scope, both from the academic point of view and industrial perspective (mainly companies’ activity) has been growing steadily in recent years. An analysis of the data sources and entity distribution in the documents found provides several important insights:
Data Source Distribution (1,628 references from 2010 to the present) and Entity Distribution for Patient Empowerment and Patient Adherence to Treatment (source: Linknovate.com)
The field is developed primarily via scientific publications, which indicates a clear academic nature and a (likely) undeveloped state of the field. This confirms what reviews (and reviews of reviews36) suggest about the topic.
Looking at the contribution to the field by organisations in the figure above, almost 2/3 (64%) comes from either university groups or research centres, whereas only 1/3 comes from small companies and corporations. Interesting enough, 2017 appearsDRAF to be a tipping point in this sense, with a much bigger participation of companies, although it is too early to confirm this trend.
Entity authorship contribution in the references found (source: Linknovate.com)
By examining each of the three diseases that EMPATTICS tackles DIABETES,HEARTFAILURE(HF)and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) , one can get an idea of what the big picture is within the fields of ‘adherence’ and ‘patient empowerment’:
Percentage of Diabetes, COPD and HF Adherence to Treatment & Patient Empowerment references over all. References from 2010 to 2017. (Source: Linknovate.com)
This means that the level of R&D within this topic which stands for probably the largest problem to date in patient therapy, the greatest costs for the health care systems and greatest opportunity to date isasmallpercentageofthetotal(~2.36%inthecaseofDiabetes,similarforCOPD,andslightly higher, at 3.5%, for Heart Failure).
Therefore, this represents an unparalleled opportunity in terms of products to be developed, and one of the main roles for technology to play in healthcare therapy and biomedicine, in the short and medium-term.
Regarding certain active categories of technologies (or applications of technology) -i.e. virtual reality, artificial intelligence, wearables, serious games and a miscellanea of apps, platforms and hardware devices-, a number of conclusions regarding end users' needs with high-room for innovation have been extracted:
The vast majority of the work belongs to the mobile (mHealth) or e Health realms. New devices and user interfaces, such as virtual assistants (AI), virtual reality (VR), and wearables had important linear growth in terms of both academic research and (market-ready) products from 2010 to 2014 and substantial growth in 2015, with a decay in 2016 (driven by the decrease in activity of eHealth and Gamification that cannot compensate for the growth in Wearables)
The possibility to turn off data acquisition or certain privacy settings seems to be a fundamental feature for future users. Privacy concerns have been raised lately. In fact, data privacy and trust has become a central topic for the European Commission and a hot research topic, both in the industry and from the academic point of view. Growth in references for this topic consistently exceeded 30% year on year over the last five years; with public funding mushrooming in 2015 from an average of 15 grants and 70M€ in funding to 160M€ and 41 grants in Europe alone, in 2015.
Standardisation of data formats/reports and interoperability with major clinical history data systems is also a green field. Standards and compatibility constitute a large problem in the huge amount of information that is gathered nowadays and how these sensors and devices share data with each other; this is not usually tackled by the products launched, or at least not usually brought to the consumer as a benefit or positive feature. Awareness needs to be raised.
Regarding the information provided to the patient, most products focus on data they generate and where they have a greater degree of control. Integrating with other systems is regarded as costly and applications, or systems like VR and AI-based solutions, do not concentrate on analysing historic data, but recent data. The only area where this need is addressed in some way
is AI-based solutions, but these focus on the prediction of data, some of them using historic data from the patient to do so.
In the field of research into adherence promotion, many solutions can be found proposing rewards for patients. A number of solutions opt for physical incentives, in the form of discounts or gifts in pharmacies, while others opt for rewards in the form of “visual validations” which inform patients visually on their devices each time they comply with taking their medication. Visual validations constitute an important advance as they entail no effort on the part of patients, who do not have to record anything: everything is performed automatically.
As indicated above, very few references and products address multi-disease or transversal needs. Thus, although several products and lines of research concentrate on these ‘open channels for physician-patient communication’ or doctor-patient-enhanced communications through data stored in the patient’s specific device, wearable or app, none of them are oriented towards any chronic disease in a generic way.
Open market consultation
The EMPATTICS Consortium has carried out an Open Market Consultation through the deployment of the five different methods:
Conference attendance. The EMPATTICS Consortium met stakeholders at nine healthcare and eHealth events throughout the European Union, where it promoted the project and held discussions.
Open Market Consultation Questionnaire. The questionnaire, which was available online on the website, served as a tool to inform industry stakeholders about the project, to collect their feedback and to provide them with an opportunity to express their interest in creating partnerships with other stakeholders and request video calls. A total of 57 questionnaires were completed, representing 55 entities and 11 countries; of these, 63% expressed interest in submitting tenders.
Virtual Meetings. EMPATTICS arranged web presentations with industry and relevant stakeholders after receiving 25 video call requests through the Open Market Consultation Questionnaire (only 5 of these responded to the actual invitation from the Buyers). During the 20 to 30-minute meeting, the EMPATTICS representative presented the project. The entities were asked to elaborate on their products and potential solutions for the health challenge, and their questions, as already recorded in the questionnaire.
Direct Communication. An official email address was set up for interested stakeholders to contact EMPATTICS with questions or information requests.
Workshops. Based on ease of access for companies and venue availability, partners chose to hold 4 workshops across Europe (Copenhagen, Santiago de Compostela, Zaragoza and Paris) during November 2016, with 109 participants from different entities and countries attending the workshops. The discussions at the workshops focused mainly on the companies’ doubts regarding the challenge and the tender materials and requirements.
All the topics brought up during this interaction with suppliers (mainly at the workshop discussions and through the questionnaire) have helped to formulate a better definition of the project and to improve the tender material and the FAQ on the project website.
3.3. PCP Challenge
This procurement is for R&D services to develop solutions to tackle the following challenge:
To develop new, cost-effective, scalable, interoperable and non-intrusive Information and Communication Technology solutions for patients with chronic diseases, which provide self- management tools on adherence to their care plan and acknowledgement of their disease in order to increase their empowerment and management of life. To address the need for the solution to support patients with information, monitoring and data analysis of their disease evolution and communication with health professionals responsible for their care plan.
The rationale of the focus by EMPATTICS on these chronic conditions is based on the high incidence, the social costs of these diseases, and the impact that adherence has on them, as well as empirically observed experiences of modifiable self-management behaviours and ICT use in relation to them.
The intended EMPATTICS technological solutions will improve the level of knowledge and involvement of patients in the management of their disease and the prescribed treatments. This requires a multidisciplinary approach that encompasses the following aspects:
Increasing awareness of and knowledge about the importance of adherence,
Monitoring and evaluating patient adherence to agreed action plans,
Providing valuable information for the self-management of patient diseases,
Helping patients to develop healthy adaptive behaviours,
Facilitating communication between patients and health professionals.
This is a common challenge shared by all procurers in the buyers group.
Solutions shall be developed considering patient/carers and healthcare professionals experience and preferences during both the design and implementation phases. The products and innovations achieved at this PCP shall arise through co-operation and co-creation between health-care organisations, professionals and patients/families. Bidders are expected to consider the involvement of end-users very early in the product design process. It must be considered that target users will be patients of each of the three chronic disease groups chosen by EMPATTICS (i.e., Diabetes, COPD and Heart failure), a combination of these, and even a combination of these with other conditions, at different stages of their onset and with different personal profiles (adults, elderly dependent/active people, etc.). Owing to this, patients/carers will have specific contexts, circumstances, motivations, preferences, levels of health literacy and digital competences. As the requested solutions must be highly usable and adaptable, bidders shall pay special attention to the use of an iterative design process, especially in phase 1 but also in phases 2 and 3.
The main quality/efficiency improvements sought for have been agreed on as being solutions that can be demonstrated during the testing phase:
A measurable increase in patients ́ empowerment
A measurable increase in patients ́ adherence to the care plan.
(TRUNCATED please visit the public link)