DATA2PERSON Big Data & Health Self/joint management and personalization

Transcription

1 COMMIT2DATA Call for Proposals DATA2PERSON Big Data & Health Self/joint management and personalization April 2017 The Hague, April 2017 Netherlands Organisation for Scientific Research (NWO)

2 Table of Contents 1 Introduction Background Available budget Validity of the call for proposals 2 2 Aim 3 3 Guidelines for applicants Who can apply What can be applied for When applications can be submitted Preparing an application Specific grant conditions Submitting an application 10 4 Assessment procedure Procedure Criteria 13 5 Contact and information details Contact Other information 15 6 Annexe(s) Content focus Definitions Clauses for in kind and in cash contributions from private and public parties Format for letter from principal applicant Format of matching statement by private partner(s) 23 The original Dutch-language text of the brochure is the authoritative version. Where the Englishlanguage text is open to a different interpretation, no additional rights may be derived from it.

3 1 Chapter 1: Introduction / COMMIT2DATA DATA2PERSON 1 Introduction 1.1 Background It is the ambition of NWO to support the Knowledge and Innovation Agenda ICT (KIA-ICT) and the Knowledge and Innovation Agenda Health~Holland Pro~Motion by issuing a call for proposals from public-private partnerships focused on the promotion of a healthy society in the future. This call is a partnership between COMMIT2DATA 1, NWO Domain Science (ENW) and Domain Social Sciences and Humanities (SGW), Applied and Engineering Sciences (TTW), National Initiative Brain & Cognition (NIHC), The Netherlands Organisation for Health Research and Development (ZonMW), and the Ministry of Economic Affairs. The call is formulated and rolled out in consultation with the Ministry of Health, Welfare, and Sport (VWS). This call aims to stimulate collaboration between knowledge institutes and innovative companies and organizations for the promotion of groundbreaking big-data research on the theme of Health in the COMMIT2DATA programme. The KIA ICT describes the ICT innovation themes that give several top sectors economic advantages while presenting them with scientific challenges. The action lines range from user-inspired fundamental and applied ICT research to stimulating innovation through the use of modern ICT in monitoring and control. The KIA ICT appoints two related domains to take up the lines of action. COMMIT2DATA is one of these domains focused on strengthening knowledge, valorization, and dissemination of data science, stewardship, and technology for the top sectors. The objective of COMMIT2DATA is to finance larger related projects in the different subprogrammes to ensure they remain cohesive and to stimulate partnerships. Research, valorization, and dissemination are conducted in the vertical subprogrammes based on domain-specific demand management. 1.2 Available budget The budget for this call for proposals is approximately 5,500,000. NWO and ZonMW have jointly made 3,500,000 available while the Ministry of Economic Affairs has contributed 2 million. NWO reserves 5% of the budget for project management and supporting programme initiatives. The total available budget for projects in this call is 5,225,000. The expected contribution from private partners is approximately 2 million, about half of which will be in cash. The precise terms and conditions can be found in paragraph 3.5. Only applications that have been assessed as excellent or very good are eligible for funding. Proposals of insufficient quality are not eligible for funding, even if the budget is available. 1

4 2 Chapter 1: Introduction / COMMIT2DATA DATA2PERSON 1.3 Validity of the call for proposals This call for proposals is valid for the assessment procedure of proposals submitted before the deadline of 5 September 2017, 14:00 hrs CEST.

5 3 Chapter 2: Aim / COMMIT2DATA DATA2PERSON 2 Aim COMMIT2DATA is focused on strengthening knowledge, valorization, and dissemination of data science, stewardship, and technology for the top sectors. This programme places great emphasis on monitoring and community management using a monitoring and dissemination plan (see 3.5). A focused approach is needed to shift the boundaries of contemporary data science and big-data solutions. This call is a partnership between COMMIT2DATA 2, NWO Domain Science (ENW) and Domain Social Sciences and Humanities (SGW), Applied and Engineering Sciences (TTW), National Initiative Brain & Cognition (NIHC), The Netherlands Organisation for Health Research and Development (ZonMW), and the Ministry of Economic Affairs. The call is formulated and rolled out in consultation with the Ministry of Health, Welfare, and Sport (VWS). The COMMIT2DATA programme has as its goal to contribute to the development of effective, efficient, and responsible personal empowerment methods for a future healthy society in partnership with other scientific disciplines. The focus of this programme is on the way in which Data Science can make a contribution to a personalized offer and possibilities for the self/joint-management of the individual health situation. Important questions relating to this call are: What works and what doesn't? Why? Or why not? For who does it work, and for who doesn't it? The concept of health is broadly interpreted in the context of this DATA2PERSON call. Healthy individuals as well as patients may serve as the subject of the research, which should contribute to the personal empowerment of people through selfmanagement, shared management, and personalization across the full spectrum from complete health to the presence of disease and loss of independence as a result of disease. Where possible, it is vital that end users (patients and health care providers) be involved, such as in matters involving management using personal data. Research proposals should focus on Data Science and contain a clear ICT research component that aims to develop new digital methods and respond to a content-driven demand for personalization and the self/joint-management of health. In addition to Data Science, the input of other relevant scientific disciplines towards this call is necessary. These are disciplines that can identify and articulate the issues relating to this call and support the development of a solution-oriented approach or test their effectiveness and feasibility in practice. Research that only generates new insights into health and disease mechanisms or detects predictors for health or disease processes without addressing the enhancement of self/joint-management or the promotion of a personalized offer does not fall within the scope of this call. Although legislation and ethics are important preconditions for the development of new self-management methods, this is not the focus of this call. Research projects focused only on these themes fall outside the scope of this call. Given the importance of these themes, at a later stage it will be considered if and what can be learned about the legislation and regulatory and ethical issues faced by the project proposals. 2

6 4 Chapter 2: Aim / COMMIT2DATA DATA2PERSON An in-depth description of the content focus of this call is included in annexe 6.1.

7 5 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON 3 Guidelines for applicants 3.1 Who can apply Applications can be submitted on behalf of consortiums consisting of at least two academic departments from a research institute or institutes recognized by NWO 3 and one public or private partner that alone, or together with multiple private and public partners, meets the private/public matching criteria. See annexe 6.2 for the definition of private/public matching. In addition to data science researchers, researchers from the health, medical, social, and behavioural sciences are also involved, depending on the research question. Applications are submitted by a principal applicant. The principal applicant is an experienced researcher with a PhD (a professor, assistant professor, or a researcher with a similar appointment) who has a tenured or temporary appointment at a Dutch university or a research institute recognized by the NWO 4 for the duration of the application process and the project. The principal applicant is responsible for the project and carries the financial responsibility for the project. An application can have multiple co-applicants. For academic co-applicants, the same conditions apply as for the principal applicant: experienced researchers with a PhD with a tenured or temporary appointment at a knowledge institute for the duration of the application process and the project. Private or public partners can be listed as co-applicants. Private and public partners are not eligible to receive NWO funding, but contribute in cash or in kind to the research. Upon submission of the application, the involvement of participating private and public partners must be clearly indicated. Researchers from universities of applied sciences, TO2 federation organizations, national institutes, and the non-university part of Wageningen University & Research may act as co-applicants and be a member of a consortium as a knowledge institute. In this way, they can contribute to a project and have access to the knowledge and expertise. However, they are not considered to be public partners who can meet the in kind or in cash matching criteria of the project budget for which funding is being requested (see annexe 6.2) and do not qualify for funding from NWO. 3.2 What can be applied for The costs for the temporary appointment of academic staff and non-academic support staff for the project at the research institute are eligible for NWO funding and include staff such as software developers, lab technicians, etc., as are the project-specific costs for materials, trips, machines, and other project-related costs. The maximum eligible amount for project-specific (non-staff) costs is set at a maximum of 30% of the total project budget to a maximum of 200, See NWO regulation on granting at See NWO regulation on granting at

8 6 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON Staff costs are eligible for a grant in accordance with the most recent Agreement on Funding Academic Research, which has been signed by NWO, VSNU, NFU, ZonMW, KNAW, and VFI. The agreement and the maximum amounts for staff costs can be found at (available in Dutch only) and Each PhD candidate or postdoc researcher receives an individual bench fee of 5,000 to cover the costs of travel, printing a thesis, etc. The amounts of funding and conditions for matching can be found in paragraph 3.5. Not eligible for funding are costs for permanent staff members, student-assistants, maintenance, insurance, and publication costs. Overhead costs such as for computers and laptops, regular software, and other costs that are part of the standard facilities of universities, research institutes, or workshops/labs are not eligible for funding. The general costs for project management and coordination, and non-specified costs such as a provisional sum for unforeseen items, are not eligible for funding. The basic principle for the final grant allocation is compliance with the guidelines laid down in the audit protocol of the Ministry of Education, Culture, and Science and the universities for the auditing of NWO projects. 3.3 When applications can be submitted The deadline for the submission of proposals is 5 September :00 hrs CEST. When you submit your application to ISAAC you need to enter several additional details online. Make sure you allow enough time for this and start applying at least a day before the closing date. Applications that are submitted after the deadline will not be included in the procedure. 3.4 Preparing an application The application consists of three parts: a factsheet, an application form, and a statement of the agreements made with the private and public partners. - Download the application form in the ISAAC online application system or from the call website. Complete the application form. Save the form as a PDF and upload it to ISAAC. The application should be written in English. Attach a copy of the letter from the principal applicant including the matching statements of the private or public partners as attachments in PDF format in ISAAC. Both the letter and the annexes should be drawn up according to the established layout. In annex 6.4 you find the format for the letter Declaration of agreements with private and/or public partner(s). In annex 6.5 you find the format for the matching statement matching statement by private and/or public partner(s). By means of the matching statement addressed to NWO, the private and/or public partner commits to the agreed contribution to the project if the project is awarded by NWO. The matching statement is unconditional and does not contain resolutive conditions, except when the application is not funded.

9 7 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON The letter and the matching statement can also be downloaded from the call website. It is not permitted to attach supplementary information to the application, such as additional results, manuscripts, support letters, etc. In accordance with the agreement between NWO and VSNU, applicants must inform their institute about their applications. A copy of the application must be supplied to the academic director or dean of the institute or faculty. NWO assumes that the applicant s institute has been informed and that the university or institute accepts the NWO Regulations on Granting. 3.5 Specific grant conditions Project conditions The NWO Regulations on Granting 2015 ( and the Agreement on Funding of Scientific Personnel ( available in Dutch only) apply to this Call for Proposals. The projects have been formulated according to the rules for public-private partnerships for the programming and implementation of fundamental and applied research presented to the House of Representatives of the Netherlands in One or more public or private partners work with at least two different academic departments on the projects within this call. The total contribution (in cash and in kind) of the public and private partner(s) amounts to a minimum of 30% of the total project costs, or a maximum of 50%. The in kind and in cash contribution of the private and public partner(s) both amount to no less than 15% of the total project costs. NWO is responsible fort he rest of the project costs: The grant is a minimum of 250,000 and a maximum of 1 million. The total project costs are no less than 500,000 and no more than 2 million. You can calculate whether your project budget meets these conditions using our calculation tool This can be downloaded from the call website.

10 8 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON Schematic representation of the minimum and maximum variant in contributions of the project costs. Examples minimum options Examples maximum options Project costs Funding and matching Private/public partner(s) k NWO k Cash In kind Total (30%) (70%) (50%) (50%) (50%) (50%) Total project costs k Projects must comply with the following conditions: The duration of the project is a maximum of five years. The project must start within six months after the project is awarded. The private and/or public partner(s) receive(s) an invoice from NWO for the cash contributions. This in cash contribution can be invoiced in instalments. The in cash and in kind contributions as described in the budget correspond to the matching statements in which the contribution by public and/or private partners is promised to NWO. Private and public partners can finance part of their contribution to the project costs in kind. In kind contributions are essential for the project and are incorporated in the proposal s budget calculations for research costs. See annex 6.3 for the conditions with which the in kind contributions must comply. Researchers apply the FAIR principles with respect to sharing of data 7 ; Applicants are expected to contribute to additional reporting, meetings, and periodic evaluations within the framework of COMMIT2DATA. Applicants are expected to contribute to: 1. COMMIT2DATA-wide synergy. Researchers actively contribute to the dissemination of their results within the COMMIT2DATA community, especially towards application domains that are not directly addressed in their own project, for example through participating in COMMIT2DATA-wide events; 2. Subprogramme synergy. Researchers actively contribute to the subprogramme that evolves from the present call, for example through the participation in events that are organized within the subprogramme; 3. Big-data hubs. Where possible, collaboration is established with the relevant COMMIT2DATA big data hubs and field labs (existing or in development) as a means to inform the valorization and dissemination activities towards private and/or public partners. 4. Reporting. Researchers report regularly (twice a year) and transparently about the progress and achieved results on the following: (i) scientific output (quantity and quality); (ii) maintaining the FAIR principles as well as other considerations regarding the use of datasets (such as ethical and legal issues); 7

11 9 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON (iii) the collaboration with involved private and/or public partners; (iv) the valorization activities; (v) the synergy with other projects within the own subprogramme as well as COMMIT2DATA as a whole; (vi) dissemination activities other than in relation to science, i.e. publications in scientific journals, lectures for the general public, popular science publications, contributions to radio and TV, and other media. The project partners (the involved knowledge institutes and private and/or public partner(s)) must sign a project agreement including NWO before the start of the project. In this agreement, the PIL and knowledge transfer, and other matters such as payments, progress, and final reports and confidentiality, should be dealt with. NWO will make a model agreement available on the website of the programme. Open Access All scientific publications resulting from research that is funded by grants derived from this call for proposals are to be freely accessible worldwide through Open Access at the time of publication. There are several ways for researchers to publish Open Access. A detailed explanation regarding Open Access can be found on Data management Responsible data management is part of good research. NWO wants research data that emerges from publicly funded research to become freely and sustainably available, as much as possible, for reuse by other researchers. Furthermore, NWO wishes to raise awareness among researchers about the importance of responsible data management. Proposals should therefore satisfy the data management protocol of NWO. This protocol consists of two steps: 1. Data management section The data management section is part of the research proposal. Researchers should answer four questions about data management within their intended research project. Therefore, before the research starts, the researcher will be asked to think about how the data collected must be ordered and categorized, so that it can be made freely available. Measures will often need to be taken during the production and analysis of the data to make sure the data can be stored and disseminated later. Researchers can state which research data they consider to be relevant for storage and reuse. 2. Data management plan After a proposal has been awarded funding, the researcher should elaborate the data management section into a data management plan. The plan should be submitted to NWO via ISAAC within a maximum of four months after the proposal has been awarded funding. NWO will approve the plan as quickly as possible. Approval of the data management plan by NWO is a condition for disbursement of the funding. The plan can be adjusted during the research. Further information about the data management protocol of NWO can be found at Nagoya Protocol The Nagoya Protocol became effective on 12 October 2014 and ensures an honest and reasonable distribution of benefits emerging from the use of genetic resources (Access and Benefit Sharing; ABS). Researchers who make use of genetic sources from the Netherlands or abroad for their research should familiarize themselves with the Nagoya Protocol ( NWO

12 10 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON assumes that researchers will take all necessary actions with respect to the Nagoya Protocol. Personal Data Protection Act The projects must adhere to the laws that govern the protection of personal data. 8 On 1 July 2017, the Wet aanvullende bepalingen verwerking persoonsgegevens in de zorg (additional provisions act for the processing of personal data in health care) will come into force. This law governs the electronic exchange of patient information and the right of patients to have electronic access to files. The European General Data Protection Regulation will also come into force on 25 May This regulation replaces the Personal Data Protection Act. Ethical aspects Research proposals that can elicit ethical questions must be considered carefully before the research starts. For certain research projects, a statement of approval is needed from a recognized medical ethics review committee (MERC) or animal experiments committee (DEC). In addition, for certain research proposals a licence is needed in accordance with the Population Screening Act (WBO). Further information about the MERC is available from the Central Committee on Research Involving Human Subjects (CCMO). Information about the DECs can be obtained from the Dutch Association of Animal Experiment Committees and information about the WBO can be obtained from the Health Council of the Netherlands An applicant is responsible for checking whether their research proposal can elicit ethical questions and, if applicable, for obtaining a statement of approval from the appropriate ethics committee and obtaining a licence in accordance with the WBO. NWO endorses the Animal Experiments Openness Code and the Biosecurity Code of Conduct. A research project can only start if NWO (if applicable) has received a copy of the ethical statement of approval and/or WBO licence. For complex questions about ethical issues, NWO reserves the right to consult an external advisor. If, after consulting with the applicant, NWO is of the opinion that an ethical assessment is needed for an application, then the applicant is still required to take measures for an assessment by an ethics committee. If the necessary statement of approval from the ethics committee is not obtained, then the funding will be withdrawn. 3.6 Submitting an application An application can only be submitted to NWO via the online application system ISAAC. Applications not submitted via ISAAC will not be taken into consideration. A principal applicant must submit their application via their own ISAAC account. If the principal applicant does not have an ISAAC account yet, then this should be created at least one day before the application is submitted to ensure that any registration problems can be resolved on time. If the principal applicant already has a NWO account, then they do not need to create a new account to submit an application. When you submit your application to ISAAC you will also need to enter additional details online. You should allow for sufficient time to do this. 8 wetten.overheid.nl/bwbr /

13 11 Chapter 3: Guidelines for applicants / COMMIT2DATA DATA2PERSON For technical questions, please contact the ISAAC helpdesk (refer to Section 5.2.1).

14 12 Chapter 4: Assessment procedure / COMMIT2DATA DATA2PERSON 4 Assessment procedure 4.1 Procedure General The NWO Code of Conduct on Conflicts of Interest applies to all persons and NWO staff involved in the assessment and/or decision-making process. 9 The data management section will not be included in the decision about the awarding of funding. However, both the referees and the assessment committee can give advice concerning the data management section. After the proposal has been awarded funding the applicants have to elaborate this section into a data management plan making use of the advice from the referees and the committee. NWO gives all full proposals a qualification. 10 The applicant is informed of this qualification when the decision on whether or not to award funding is announced. Only applications that have been assessed as excellent or very good are eligible for funding. NWO has stipulated in its Regulations on Granting applying to this call that all NWOfunded research must be carried out in accordance with internationally accepted standards of academic conduct as laid down in the Dutch Academic Integrity Code 2012 (VSNU). 11 Eligibility Two steps preceed the assessment procedure. In the first step it is assessed if the application can be taken into consideration. For this, the criteria stated in chapter 3 of this call for proposal will be applicable. In a second step, the chair of COMMIT2DATA together with the scientific member of Team ICT and, if required, with the recommendation from an assessment committee appointed by the Board of Domain Science (DB ENW) will evaluate the suitability of the application for the goal of the call (see chapter 2 and annex 6.1) at the start of the procedure. NWO also verifies whether the application meets the submission criteria (see chapter 3). Only applications that meet both conditions are considered eligible and are processed by NWO. Applicants whose proposals do not meet these conditions will be notified by letter. Referees All eligible proposals will be sent to external referees for assessment. Referees are independent experts in the subject discipline of the applicant. They will write a referee's report in which they state the strengths and weaknesses of the proposal. The applicant may provide up to five suggestions for possible foreign referees who could be consulted by fully completing the referee list in ISAAC. The list of suggestions for referees must not contain any names of researchers that the applicant has worked with during the past three years, is currently working with, or expects to work with in the near future. This concerns not only co-authors but other

15 13 Chapter 4: Assessment procedure / COMMIT2DATA DATA2PERSON forms of collaboration as well. Only referees who are not involved 12 with the applying research team and the proposal will be consulted. The suggested referees must not be working in the Netherlands. The assessment committee will also be asked to provide suggestions. From this pool of experts, a number of independent referees will be asked to review an application. In addition to the applicant s suggestions, other experts will be brought in as referees in all cases. Non-referees The applicant has the possibility of providing up to five non-referees. This is not mandatory. Rebuttal The anonymized referees' reports will be sent to the applicant, who then is invited to send a written response (the rebuttal). Assessment committee The assessment committee discusses and prioritizes the applications during a meeting and advises the DB ENW. It is the assessment committee's task to come to an independent consideration based on the application, the referees' reports, and the rebuttal. The referees' reports are an important guiding principle for the final assessment. These expert reports help the assessment committee to form an independent opinion, but do not need to be endorsed by this committee. The assessment committee considers the referees' arguments and determines whether the applicant's reply is a well-formulated response to the critical notes in the referees' reports. In addition, unlike the referees, the assessment committee has an overview of the quality of all the submitted applications and rebuttals. Decision The assessment committee's prioritization and recommendation is presented to the DB ENW, which subsequently makes a decision. Indicative timetable for each deadline Deadline 5 September 2017 Hearing and Rebuttal Mid-December 2017 Committee meeting Mid-January 2018 Decision February Criteria An application can only be granted when the evaluation committee qualified all three criteria as 'very good' according to the NWO qualification system. The eligible applications will first be assessed by the referees followed by an assessment by an independent assessment committee based on the following criteria. 1. academic quality (40%) a. scientific approach; b. clarity of focus and objectives; c. feasibility; 12 The Conflict of Interests Code can be found on the NWO website: This states the possible involvements.

16 14 Chapter 4: Assessment procedure / COMMIT2DATA DATA2PERSON d. innovative aspects; e. balance between goals and available resources (budget, staff). f. relevance to Data Science and to the COMMIT2DATA programme; g. relevance to self/joint-management and/or personalization for health and expanding the possibilities for the management of personal health and care data Quality of the consortium (40%) a. track record of the academic partners; b. track record of the private and/or public partners; c. synergy, complementarity, and added value of cooperation; d. involvement of end users (citizens/patients) if relevant; e. availability of infrastructure within the consortium, including data needed for the implementation of the project. 3. Knowledge utilization (20%) a. quality of the knowledge utilization plan; b. involvement of end users and partners; c. ethical and legal feasibility; d. extent of innovation; e. connection and active contribution to the horizontal knowledge transfer within COMMIT2DATA. 13

17 15 Chapter 5: Contact and information details / COMMIT2DATA DATA2PERSON 5 Contact and information details 5.1 Contact Specific questions For specific questions about this call for proposals please contact NWO: Dr. A. (Astrid) Zuurbier tel. +31 (0) Dr. M.J. (Marijn) Hollestelle tel. +31 (0) DATA2PERSON@nwo.nl Technical questions about the ISAAC electronic application system For technical questions about the use of ISAAC please contact the ISAAC helpdesk. Please read the manual first before consulting the helpdesk. The ISAAC helpdesk can be contacted from Monday to Friday between 10:00 AM and 5:00 PM CET on +31 (0) However, you can also submit your question by to isaac.helpdesk@nwo.nl. You will then receive an answer within two working days NWO Appeals Committee Where appropriate, candidates can use NWO s appeal procedure to lodge formal appeals against decisions within six weeks after notification of the decision. After lodging an appeal the candidate will be invited to attend a hearing of the NWO Appeals Committee. Further information on the appeals procedure can be obtained from the secretary of the NWO Objections Committee, Ms C. Hansildaar, c.hansildaar@nwo.nl, telephone +31 (0) Other information A full English version of this Call for Proposals is available on the website of the programme where the application forms can be downloaded as well.

18 16 Chapter 6 Annexe(s) / Call ICT-Roadmap 6 Annexe(s) 6.1 Content focus DATA2PERSON Big data & Health Self-management/shared management and personalization Big data The production of data is increasing at a rapid pace in all aspects of life: logistics, social media, consumer products related to the internet, scientific experiments, mobility, crime prevention, production, health care, financial transactions, and so much more. This growth is stimulated by the transition from analogue to digital technology and the concurrent increase of digital data generated by consumers, academics, companies, and governments. By making smart use of data and data technology, exciting new innovations are created that were thought of as impossible until recently and which can have far-reaching consequences. This gives the way in which we have organized knowledge in academia, the business community, and society a new dimension and means new scientific questions can be articulated and researched while making a valuable contribution to solving relevant social challenges such as issues related to health. Big data is an umbrella term that is used for data collections that are so large or complex that traditional analyses techniques are unable to deal with them. The five Vs model of big data identifies volume, velocity, variety, veracity, and value as markers for big data. 14 These can be heterogeneous large and small datasets, including unstructured data. Data Science researches generic methods to determine eye-opening and reliable insights from data and to communicate these effectively between users and their environment. Data Science is a scientific field that uses methods such as data and process mining, machine learning, statistics, text and image analysis, information retrieval, and visual analytics to design and verify computational models for clustering, classification, and prediction. Predictive analytics are used to explore correlations between data. Technologies such as context awareness and Intelligent Interaction are used for informed decision-making processes; Gamification is a dialogue technology that can help to promote behavioural change. It is essential to include subjective experiences in this by using techniques such as experience sampling. Data Science brings us exciting scientific challenges and intriguing new insights. Data scientists are predominantly searching for interesting and robust patterns in data and methods for combining data from different sources. If something is interesting, it often means that something unexpected has been observed, such as patterns that result in new and astonishing insights. Data Science enables us to create better predictive models with less assumptions and theories than models based on small samples and hypotheses. Making smart use of data can create a great deal of value, yet it is also marred by restrictions and dangers. For example, incorrect use or input can result in inaccurate conclusions. A comprehensive knowledge of this field, collaboration with other disciplines and end users, and knowledge of the application domain are required if Data Science is to be applied correctly. Data Science & Health Using Data Science to promote health practically means using different types of data from various sources to formulate lifestyle advice, prevention, diagnostics, and treatment tailored to the individual, and to provide personalized, effective, real-time feedback. A significant development regarding health has been the shift from a general to a more personalized offer 14 Big Data: Using SMART Big Data, Analytics and Metrics To Make Better Decisions and Improve Performance, Bernard Marr, 2015

19 17 Chapter 6: Annexe(s) / COMMIT2DATA DATA2PERSON and the focus on the participation of the individual (self-management) and their living environment (health care providers, caregivers, etc.) in their own health (joint management). Health care individualizes and the patient transforms from a passive receiver of advice from the health care provider into an active participant who can manage their own health and their health-related data. 15 With the rise of virtual networks and forums and the possibility of monitoring your health using sensors and the ability to give citizens the responsibility of managing their own health-related data, citizens are able to become a driving force for new developments that promote health and vitality. Using data technology, data can be collected by people themselves and this aspect alone is innovative and expands the boundaries of traditional health care. This will require health care providers and health care users to assume different roles related to the management of personal health-related data. Personalization and the self/joint-management of health-related questions require the individual and the members of a team that safeguards the health of an individual to play an active role. A team may consist of health care providers and caregivers, but can also include a group on the Internet or other social forms of interaction. The correct provision of information is invaluable for this group of people if they are not professional health care providers themselves. This will result in information asymmetry between doctors and patients being reduced and citizens, as patients, will have insight into their own health and medical information from different health care providers in a personal health care environment that displays their own health information and information from e-health applications 16 and make these available for other purposes such as big data research. The P4 Medicine model which stands for Predictive, Preventive, Personalized, and Participatory Medicine 17 is applicable here. The unique characteristics of the individual determine the personalized provision of health care. Health is predominantly the result of interplay of genetics (genotypes) and the environment in which the individual finds themselves. Behaviour is a dominant factor for a healthy life and the prevention of illness and disease but it is also an important factor for regulating chronic conditions and comorbidity. Nutrition and lifestyle are important factors just like psychological influences, the social environment, and exposure to factors in the physical environment such as UV rays, and air quality. The smart collecting, combining, and analysis of biological and medical data about lifestyle and environmental factors of the individual and their population group will result in detailed patterns that can be predictive for the future health and illness of an individual. It is important that these analysis techniques also present solutions that have been proven effective for end users. Big data, together with existing scientific theories and observations, has delivered meaningful insights. In addition to this, personal communication strategies are needed to translate these insights into concrete self/jointmanagement strategies that are supported by health care providers where necessary. The question is how proven effective data-driven solutions for personalization and selfmanagement/shared management can be developed and supported. Important questions include: Which forms of measurement, feedback, and communication really have an effect? How do you reach, involve, and motivate people who are less digitally skilled? The health care provider is also an important party to consider here. How do you make the multitude of new insights/patterns understandable and usable in the restricted time that this provider has with their patient? How do you embed the use of big data in current clinical working processes? What adaptivity in the human-machine interaction needs to be designed to make the measurement and use of big data safe and robust? Besluit van de Minister van Volksgezondheid, Welzijn en Sport van 14 december 2016, kenmerk CZ houdende vaststelling beleidskader subsidiëring Versnellingsprogramma Informatie-uitwisseling Patiënt en Professional (Decree by the Minister of Health, Welfare and Sport of 14 December 2016, reference no cz, establishing the policy framework for the funding of the acceleration programme patient and professional information exchange) 17 P4 Medicine: Personalized, Predictive, Preventive, Participatory, A Change of View that Changes Everything, Hood et al., 2008.

20 18 Chapter 6: Annexe(s) / COMMIT2DATA DATA2PERSON Data sources A personalized and self/joint-management approach can be informed by different data sources. Scientific and medical instruments that generate data are being used on a large scale which can be analysed with powerful computing such as sequencing and high-throughput techniques and imaging techniques. Genetic data has undergone a revolution as demonstrated by the DNA Data Deluge. 18 With next generation sequencing technology it has become possible to sequence the complete genome of a person in a short space of time and at low cost. This will contribute significantly to the development of a personalized provision of health care. Medical files are another source of data. These are now largely digitized but are also predominantly confidential and protected and must therefore be handled with care. Biobanks also contain large amounts of valuable data in the form of blood, urine, and tissue samples. Furthermore, there are large epidemiological databases that contain other types of information about the participants and their lives and patient registries also contain a great deal of relevant data. ehealth data is of primary relevance to this call. ehealth is the use of information and communication technologies to support or improve health and healthcare. ehealth data is data from medical files, the personal health environment, social media, and networks, but also electronic data about experiences and sensor data about the emotional and physical condition of an individual and their environment. Examples of sensor data include information about sleep, physiology (including heart function, blood sugar levels, and blood platelets), stress/relaxation, nutrition, exercise, patient compliance, attitude, training, and external factors such as environmental influences (particulates and exposure to light). Sensors are becoming smaller and cheaper, are easy to wear, and cause little to no discomfort by being integrated into items like a smart watch. Sensor data can be made available to the individual or their health care provider via a mobile phone and the generated feedback can be used for medical and behavioural interventions and for self/joint-management (patient compliance, requesting help on time in case of psychological stress, increased exercise, better eating habits, sleep, etc.) In short, by collecting, analysing, and interpreting this newly available ehealth and sensor data, effective and personalized health care can be developed and feedback can be directly used to support self/joint-management and personalization. Combined, these two valuable biomedical and ehealth data sources form the basis for important scientific observations about the intersection of Data Science and Health & Clinical Science with a promise to acquire important insights from their utilization for customized medical treatment and application. A large number of these sources are text. This means that advanced text analysis techniques such as text mining are necessary to unlock the information stored in these sources. When combining these data sources, legal standards and ethical considerations that could have significant impact on the implementation of studies must be taken into account. Data Science-related questions in terms of Health The possibilities for the large-scale collection of health-related data of all types have significantly increased. Current Data Science-related questions consider the safety and reliability of data-collection systems which should be secured by operating through multimodal data sources. Reliable long-term data collection is necessary if we are to follow health trends and determine the effectiveness of intervention. In the analysis of this data, time will be an important factor on different scales to formulate a prediction. New types of information, such as data relating to behaviour, lifestyle, health, and environmental factors collected from everyday life through the Internet, mobile phones, and data collected from sports watches, activity trackers, and heart rate monitors, require innovations in data analysis methods. The challenge is that this data is currently not collected systematically, meaning that systematic distortions can easily occur. The subsequent challenge is to systematically and comparably analyse and interpret this data while the health and medical sciences continue to place high demands on scientific accountability and evidence. Further challenges can also concern the automatic interpretation of large amounts of data for personalized health and of real-time decision support systems. Better and new artificial intelligence technology and self-learning 18

21 19 Chapter 6: Annexe(s) / COMMIT2DATA DATA2PERSON systems are needed to support professional health care. Another challenge faced by Data Science is to combine this type of technology with behavioural models to design individually adapting coaching systems that can support people in a motivating way on their path towards self/joint-management and healthy behaviour. The correct facilities are needed for the collection and processing of big data. This is defined by the term 'data stewardship'. These are the facilities and processes that guide the responsible storage of data and securing the future access to, and quality and analysis of data. An important aspect that is especially significant for health-related data is the regulated access to data that guarantees anonymity, integrity, and safety of data, even when different data sources are combined. Standardization can contribute to the exchangeability of data. The fragmentation of data between hospitals, citizens, research institutes, policy organizations, industry, and other parties combined with differences in laws and regulations presents a possible barrier for the use of the full potential of big data for the benefit of health. The Registratie aan de Bron programme 19 (registering at the source) is trying to address this barrier. It is not necessary to combine all data for data analysis for data applications. The questions can also be applied to the data itself. Innovative data analysis solutions and algorithms can help with this. Project proposals for this call must ensure that the data used is findable, accessible, interoperable, and reusable (FAIR principle 20 ), and is saved in a safe location. Analytics across FAIR data sources are required. The Netherlands is a leading country in the field of FAIR data and wants to remain so. It is also vital to have a working method and supporting technology that guarantees the privacy and autonomy of citizens and patients without problematizing the necessary exchange of data between different parties in the health care sector and other sectors. This call promotes Data Science Research into privacy-preserving data mining, data analytics, and machine learning across distributed datasets as long as it has a direct relevance to applications for the self/joint-management and the personalization of health. An important theme for this topic is the combination and comparison of different types of data from groups of people and diseases and disorders and the ability to zoom in from subpopulations to individuals (personalization) with comparable characteristics. In short, the personalization and self/joint-management of health requires large and reliable compound data sets combined with new, responsible big data analyses and prediction techniques. Sources: Knowledge and Innovation Agenda ICT COMMIT2DATA White Paper, 2015 Knowledge and Innovation Agenda Health~Holland Pro~Motion Big Data in de Zorg, The Netherlands Scientific Council for Government Policy (WRR), 2016 Big Data in de Gezondheidszorg, definitie, toepassingen en uitdagingen, Nictiz (national competence centre for standardisation and ehealth), 2015 The Dutch National Research Agenda (NWA) Routes, Creating value through responsible access to and use of big data, Personalized medicine, Health care research, sickness prevention and treatment', Measuring and detecting: anything, anytime, anywhere, 2016 Health RI, The NL personalized medicine & health infrastructure, The FAIR Guiding Principles for scientific data management and stewardship, M.D. Wilkinson et.al., Nature, March 2016.

22 20 Chapter 6: Annexe(s) / COMMIT2DATA DATA2PERSON 6.2 Definitions Definition private/public contribution Private and public contributions cover all cash money that does not - directly or indirectly - come from: a research organization recognized by NWO 21, universities of applied sciences, TO2 federation organizations, government organizations, and the non-university part of WUR. Netherlands Organisation for Scientific Research (NWO); Royal Netherlands Academy of Arts and Sciences (KNAW); 6.3 Clauses for in kind and in cash contributions from private and public parties 1. Possibility of participation by private and public parties through in kind contributions Private and/or public parties usually participate in NWO research programmes by making a financial contribution to the programme or project budget. Private and/or public parties may participate in the research projects of this call through partial in kind contributions under the following conditions: The total public and private contribution to a project should be a minimum of 30% (minimum cash contribution 15% and minimum in-kind contribution 15%) of the total project costs. In-kind contributions/efforts must be essential for the project and included in the budget approved by NWO for the research costs of the project application in which the private and/or public party participates (see clause 3 for prospective in-kind contributions) and fall within one of the cost categories stated in clause Commitment If an external party participates in the research project with a partial in-kind contribution as described above, the private or public party will commit to the respective in-kind contribution plus the financial (cash) contribution to the NWO project by means of a Project Agreement. The promised financial (cash) contribution will be invoiced by NWO. 3. Prospective in-kind contributions The following costs directly attributable to the research project and incurred by the private and public parties may be contributed as in-kind contributions by private or public parties in a research project (see also clause 1): Wage costs, on the understanding that they are based on an hourly rate, calculated on the basis of the annual wage for full-time employment according to the wages liable to payroll tax column on the wage sheet, plus the additional amounts due under the law or an individual or collective labour agreement for 21 See NWO regulation on granting at