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Digital Psychiatry

ISSN: (Print) 2575-517X (Online) Journal homepage: https://www.tandfonline.com/loi/tdig20

Manifesto for an international digital mentalhealth network

Eduard Maron, David S. Baldwin, Roman Balõtšev, Chiara Fabbri, Vikas Gaur,Diego Hidalgo-Mazzei, Sean Hood, Martti Juhola, Olli Kampman, SiegfriedKasper, Hilkka Kärkkäinen, Klára Látalová, Markku Lähteenvuo, NikolasMastellos, Joseph McTigue, Janek Metsallik, Andres Metspalu, David Nutt,Pirkko Nykänen, Nigel Olisa, Oliver Pogarell, Dina Popovic, Josep AntoniRamos-Quiroga, Peeter Ross, Alessandro Serretti, Marie Spies, FlorenceThibaut, Kimmo Tiainen, Jari Tiihonen, Eduard Vieta, Ülle Võhma, Roos VanWestrhenen, Belmin Zubanovic & Jonas Eberhard

To cite this article: Eduard Maron, David S. Baldwin, Roman Balõtšev, Chiara Fabbri, VikasGaur, Diego Hidalgo-Mazzei, Sean Hood, Martti Juhola, Olli Kampman, Siegfried Kasper, HilkkaKärkkäinen, Klára Látalová, Markku Lähteenvuo, Nikolas Mastellos, Joseph McTigue, JanekMetsallik, Andres Metspalu, David Nutt, Pirkko Nykänen, Nigel Olisa, Oliver Pogarell, DinaPopovic, Josep Antoni Ramos-Quiroga, Peeter Ross, Alessandro Serretti, Marie Spies, FlorenceThibaut, Kimmo Tiainen, Jari Tiihonen, Eduard Vieta, Ülle Võhma, Roos Van Westrhenen, BelminZubanovic & Jonas Eberhard (2019) Manifesto for an international digital mental health network,Digital Psychiatry, 2:1, 14-24, DOI: 10.1080/2575517X.2019.1617575

To link to this article: https://doi.org/10.1080/2575517X.2019.1617575

© 2019 The Author(s). Published by InformaUK Limited, trading as Taylor & FrancisGroup.

Published online: 10 Jun 2019.

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Manifesto for an international digital mental health network

Eduard Marona,b,c,d, David S. Baldwine,f, Roman Bal~ot�seva, Chiara Fabbrig, Vikas Gaurh,Diego Hidalgo-Mazzeii,j , Sean Hoodk, Martti Juholal, Olli Kampmanm,n, Siegfried Kaspero,Hilkka K€arkk€ainenp, Kl�ara L�atalov�aq, Markku L€ahteenvuor, Nikolas Mastelloss, Joseph McTiguet,Janek Metsalliku, Andres Metspaluv, David Nuttc , Pirkko Nyk€anenm, Nigel Olisaq, Oliver Pogarellw,Dina Popovicx , Josep Antoni Ramos-Quirogay,z,aa, Peeter Rossu, Alessandro Serrettiab ,Marie Spiesp, Florence Thibautac , Kimmo Tiainenn, Jari Tiihonenr,ad, Eduard Vietak, €Ulle V~ohmac,Roos Van Westrhenenae, Belmin Zubanovicaf and Jonas Eberhardaf,ag

aDepartment of Psychiatry, University of Tartu, Tartu, Estonia; bFaculty of Medicine, Department of Medicine, Centre forNeuropsychopharmacology, Division of Brain Sciences, Imperial College London, London, UK; cDepartment of Psychiatry, NorthEstonia Medical Centre, Tallinn, Estonia; dDocumental Ltd, Tallinn, Estonia; eDepartment of Clinical and Experimental Sciences,Faculty of Medicine, University of Southampton, Southampton, UK; fSouthern Health NHS Foundation Trust, College Keep,Southampton, UK; gDepartment of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, Italy; hHealthInformatics & Telemedicine Department, Mahatma Gandhi University of Medical Sciences Technology, Jaipur, India; iCentre forAffective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK; jBipolar DisordersProgramme, Department of Psychiatry and Psychology, Institute of Neurosciences, Hospital Clinic de Barcelona, CIBERSAM,IDIBAPS, Barcelona, Spain; kDivision of Psychiatry, Faculty of Health & Medical Sciences, The University of Western Australia,Perth, Australia; lFaculty of Information Technology and Communication Sciences, Tampere University, Tampere, Finland; mSchoolof Medicine, Tampere University, Tampere, Finland; nDepartment of Psychiatry, Sein€ajoki Hospital District, Sein€ajoki, Finland;oDepartment of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria; pGAMIANEurope, Brussels, Belgium;qDepartment of Psychiatry, Faculty of Medicine and Dentistry, Palacky University in Olomouc, University Hospital Olomouc,Olomouc, The Czech Republic; rDepartment of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio,Finland; sCentre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University,Singapore, Singapore; tMedical School, The University of Western Australia, Perth, Australia; uSchool of Information Technologies,Department of Health Technologies, Tallinn University of Technology, Tallinn, Estonia; vEstonian Genome Center, Institute ofGenomics, University of Tartu, Tartu, Estonia; wDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich,Germany; xDepartment of Psychiatry, Sheba Medical Center, Tel Aviv, Israel; yDepartment of Psychiatry, Hospital Universitari Valld’Hebron, Barcelona, Spain; zBiomedical Network Research Centre on Mental Health (CIBERSAM), Instituto de Salud Carlos III,Barcelona, Spain; aaDepartment of Psychiatry and Legal Medicine, Universitat Aut�onoma de Barcelona, Barcelona, Spain;abDepartment of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, Italy; acUniversity Hospital Cochin, Facultyof Medicine Paris Descartes, Centre Psychiatry and Neurosciences, Paris, France; adDepartment of Clinical Neuroscience, KarolinskaInstitutet, Stockholm, Sweden; aeDivision of Psychiatry, Department of Clinical Sciences Lund, Lund University, Helsingborg,Sweden; afDepartment of Clinical Sciences, Lund University, Lund, Sweden; agDepartment of Psychosis Studies, Institute ofPsychiatry, Psychology and Neuroscience, Kings College London, London, UK

ABSTRACTCurrent mental health services across the world remain expert-centric and are based ontraditional workflows, mostly using impractical and ineffective electronic record systems oreven paper-based documentation. The international network for digital mental health(IDMHN) is comprised of top-level clinicians, regulatory and ICT experts, genetic scientists,and support organizations. The IDMHN has been formed to enable the implementation ofdigital innovations in clinical practice, hereby facilitating the transformation of current men-tal health services to be more personalized and more responsive to patients and healthcareneeds. This consensus statement summarizes the consortium’s vision and strategy for furtherdevelopment of digital mental health.

ARTICLE HISTORYReceived 14 February 2019Accepted 7 May 2019

KEYWORDSDigital mental health;innovation; decision supportsystem; documental; preciseand personalizedmental health

1. Introduction

Brain disorders represent key non-communicable dis-eases of the 21st century: one in four people in theworld will be affected by mental or neurological dis-orders at some point in their lives. Around 450 mil-lion people currently suffer from such conditions,placing mental disorders among the leading causesof illness and disability worldwide [1]. Mental

disorders have a large impact on individuals, families,employers and communities, and have already sur-passed other non-communicable diseases, such ascancer or diabetes, in terms of social and economicburden. Global costs associated with mental disor-ders were estimated to be e2.2 trillion in 2010 andare expected to rise to e5.3 trillion by 2030 [2].Mental disorders rank as the main cause of years

CONTACT Eduard Maron emaron@ac.ic.uk Department of Psychiatry, University of Tartu, Tartu, Estonia� 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permitsunrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

DIGITAL PSYCHIATRY2019, VOL. 2, NO. 1, 14–24https://doi.org/10.1080/2575517X.2019.1617575

lived with disabilities (YLDs): four of the six leadingcauses of YLDs are due to mental disorders, includ-ing depression, alcohol-use disorders, schizophreniaand bipolar disorder [3]. People with mental disor-ders also have a two- to four-fold risk of prematuremortality, with a life expectancy that is on average25 years shorter than that of the general popula-tion [4].

Mental health is the main medical area in whichdecision making for diagnoses and treatment choiceis primarily based on clinical interviews, observationsand self-report measures. For the majority of mentaldisorders, no biomarkers or technical tools havebeen validated to determine diagnosis or proposethe most suitable treatment plan. The lack of usefulindicators beyond checklist diagnostic criteria is onereason why mental disorders are often misdiag-nosed, especially on initial presentation, particularlyif diagnostic and treatment guidelines are not usedsystematically. According to recent surveys con-ducted by GAMIAN Europe and meta-analyses, themisdiagnosis of mental disorders is a serious prob-lem that occurs in both primary and secondary caremental health and in general practitioner settings:

� Sixty-nine percent of patients with bipolar dis-order are misdiagnosed initially by mental healthspecialists [5].

� On average, patients remain misdiagnosed for5.0–7.5 years [6].

� Only 47.3% of patients with depression are cor-rectly diagnosed by GPs [7].

As a consequence, the global gap between theneed for treatment and its provision is large. Themedian time to receive a psychiatric assessment andappropriate psychotropic medication is between 7and 30 days in most EU countries, regardless ofsymptom severity levels [8]. However, in low andmiddle income countries (LMIC) between 76% and85% of people with severe mental disorders receiveno treatment for their disorder. The correspondingrange for high-income countries (HIC) is also high(between 35% and 50%) [9]. In addition, patientswith mental disorders have high rates of untreatedmedical conditions, for example, diabetes (45%), dys-lipidemia (88%), hypertension (62%), and smoking(90%) [10].

2. Digital mental health

Digital technologies and a rapidly developing eHealthfield together offer novel opportunities to supportand improve mental health services, including the useof internet-based interventions and smartphone appli-cations that address the prevention, treatment and

aftercare of mental health problems. With economicpressure on mental health services increasing, e-men-tal health systems could bridge treatment gaps,reduce waiting times for patients, and deliver inter-ventions at lower costs. The number of mobile health(mHealth) apps focused on mental health has rapidlyincreased; a 2015 World Health Organization (WHO)survey of 15,000 mHealth apps revealed that 29%focus on mental health diagnosis, treatment, or sup-port [11]. Nevertheless, despite the increasing evi-dence base for the utility of such interventions, thetransition and implementation of these into clinicalpractice is remarkably slow [12]. For example, in theUK, only two computerized interventions for mentalhealth problems are recommended in clinical treat-ment guidelines (i.e. ‘Beating the Blues’ for depres-sion, ‘Fear Fighter’ for panic and phobia) [13,14].Hence, it appears that amongst healthcare providersand potential service users there are barriers to theimplementation of effective computerized interven-tions that have not yet been fully identified oraddressed. The results of a recent study suggest thatindividuals are well aware of the potential advantagesof computerized or digital interventions, but may notplace particular importance on these factors [15]. Thisstudy highlights the need to raise awareness amongstclinicians and service users (most likely via these clini-cians) about the growing evidence base for digital(including mobile) mental health interventions.However, several factors, including poor usability, lackof user-centric design, concerns about privacy, lack oftrust, unhelpful in emergencies, were suggested aspotential contributors to low engagement with men-tal health apps among the patients [16]. For e-mentalhealth to have the large public health impact that isoften anticipated, there is need to improve the trans-lation of eHealth research into clinical practice. Stepstowards achieving this not only include improvingawareness in clinicians and public, but also increasingthe inclusion of information on the evidence-baseand efficacy of digital mental health interventionsinto clinical treatment guidelines. The other pathwayto improve user engagement with mHealth solutionsfor mental health is to involve end users in the con-ception, design and testing of apps [16].

3. DocuMental

DocuMental is a clinical decision support system(DSS), developed by Documental Ltd (www.docu-mental.ee) in collaboration with eHealth organiza-tions (EIT-Health: European Institute of Innovation &Technology; Estonian Connected Health), theUniversity of Tartu, and the Tallinn University ofTechnology. The system is purposefully designed fordiagnosis, treatment and management of mental

DIGITAL PSYCHIATRY 15

disorders, thereby providing a platform for digitizedclinical workflows in mental health. DocuMental is asecure, web-based software tool designed for mentalhealth service staff, including physicians, nurses, psy-chologists, social workers, care-coordinators andhealthcare managers. In order to improve userfriendliness and clinical workflows, DocuMental’sleading principle is to deliver ‘immediate results’.This aim generates added value: every step forwardis associated with results (automated documentation,increased time-effectiveness, process and progressoverview, accuracy, error avoidance, confidence, evi-dence-based data, etc.). To assist mental health ser-vice, and patient as well as public needs, ultimatelyresulting in better outcomes, Documental Ltd hasdeveloped and digitized the following modulesto date:

1. Diagnostic module: consists of digitized, struc-tured ICD-10 diagnostic criteria and ‘tick mark’choice questionnaires for all mental health disor-ders (From F00 to F98), including adult, adoles-cent and childhood disorders. The ICD-10diagnostic questionnaires are linked to DSS algo-rithms, which provide diagnostic suggestions toincrease diagnostic accuracy and allow for diag-nostic verification and differentiation.

2. Treatment module: consists of the whole list ofpsychotropic medications, including antidepres-sants and antipsychotics, registered in the EU formental health disorders, and operates via DSSalgorithms for medication- and treatment-planselection, including doses and regimens, drug-drug interactions in accordance with widely rec-ognized treatment guidelines. The treatmentmodule is linked to the diagnostic module andtracks medication choices in full accordancewith clinical presentation and diagnosis, whichhelps clinicians to avoid mistreatment and man-age care plans in a standardized way. In particu-lar, the DocuMental treatment module providesclinicians with a list of psychotropic medicationsavailable in the EU, guides them in their medica-tion choices based on patient diagnosis andpresentation, and provides treatment plans inaccordance with treatment guidelines.

3. History and routine assessment modules: inorder to contribute to standardized and digitiz-ing clinical workflows in mental health,DocuMental has also digitized, structured andautomated history and assessment modules forcomprehensive personal and family history,mental status, physical examination, risk assess-ment, and optimal sets of available clinicalscales. These modules help clinicians to performcomprehensive and standardized assessments,

which is an essential requirement for improvingdisease management and personalized care.

DocuMental was selected by EIT-Health as one of21 finalists of Business Plan Aggregator 2016 amongdigital health innovations and it was the only finalistin the mental health sector. Recently, DocuMentalhas received an Estonian-Finnish Quality InnovationAward 2017.

4. International digital mental healthnetwork (IDMHN)

Mental health systems worldwide, in their currenttraditional approach, have not yet adequatelyresponded to the need for more precise and person-alized diagnosis, treatment and management ofmental disorders. To close this gap, we formed aninternational network for digital mental health com-prising top-level clinicians, regulatory and ICTexperts, genetic scientists, and support organizationswith longstanding experience and highly recognizedexpertise in mental health, e-health infrastructuresand decision support systems. The first joint effort ofIDMHN was to verify and confirm the consistency ofICD-10 diagnostic criteria for mental disorders incor-porated in DocuMental with the original document.Through this validation step, the IDMHN’s clinicalexperts aimed to confirm that DocuMental has prop-erly implemented ICD-10 diagnostic criteria as the‘gold standard’ for mental disorders, and can transferthem into routine clinical practice. The clinicalexperts of IDMHN have also reviewed other modulesof DocuMental, including digitalized questionnairefor mental status examination and pharmacologicalregister for treatment of mental disorders. All clinicalexperts evaluated web-based DocuMental applica-tion via personal access and reported their feedbacksto the consortium. As they concluded, the diagnosticcriteria within DocuMental and diagnoses verified bythis DSS are in full accordance with ICD-10 originalcontent and diagnostic guidelines. Only minor com-ments were made about structure and small diver-gences in some questionnaires. All necessarychanges and additions were completed andsynchronized with ICD-10 standards and expert rec-ommendations in the updated DocuMental version.Generally, the clinical experts of IDMHN have foundthat DocuMental ‘is well-arranged, well-engineeredand user-friendly application; its diagnostic checklistsare in accordance with ICD-10 diagnostic criteria; itcontributes to more accurate and targeted diagnosis,and to accelerate the differential diagnosis process;platform is intuitive, comprehensive and user-friendlyin order to conduct a complete mental status assess-ment; implemented medication register connected

16 E. MARON ET AL.

to prescription option is well applicable for clinicalpractice and helps rapid orientation in the correctdetermination of treatment, i.e. clinical rules’. Afterthis first collaborative task, the members of IDMHNdeveloped the current ‘manifesto’ to summarize theconsortium’s vision and strategy for further develop-ment of digital mental health. There is an urgentneed to improve mental disease management andprovide more precise and personalized approachestowards better outcomes in mental health. Toachieve this goal, current mental health services andcare should be dramatically transformed and inte-grated with novel technologies and facilities. So far,several attempts have been made but have beenrestricted to research settings; further, only someaspects of mental health have been targeted, and ithas taken a long time to prove the concept, whichstill lacks broad implementation in routine practice.For the first time, a synergistic, multidisciplinary,worldwide consortium have joined forces to estab-lish a trusted, standardized and widely acceptedapproach for personalized mental healthcare in rou-tine practice and a digitized clinical workflow basedon highly promising and innovative solutions. Themain ambition of IDMHN is to become the widelyrecognized lead in digital mental health, to be moreproactive in terms of connections with other medicalareas, and to be more responsive in terms of collab-oration with authorities and organizations which rep-resent the interests of people with mental disordersand psychosocial disabilities. The breakthrough strat-egy of IDMHN is in coupling of existing clinicalstandards, genetic advantages and digital innova-tions, which should result in improved, effective,integrated and responsive mental healthcare byestablishing new clinical processes and new clinicalpathways in mental health and by enabling theimplementation of personalized approachesin practice.

5. The IDMHN manifesto

1. Current mental health services across world arestill based on traditional workflows, mostly usingnonfunctional electronic record systems or evenpaper-based documentation. For example,according to a recent survey conducted byUniversity of Tartu at 17 clinical sites in 12 EUcountries: two sites are still paper-based only,11 are using electronic health records (EHRs),and four are using a combination of paper-based documentation and EHRs. All clinicalsites recognized that EHRs in their current formsuffer from several limitations that hinder theirability to meet patient needs and servicedemands. In particular, current EHRs lack

decision-making functionality, are not user-friendly, are time-consuming with regard todata recording, have poor interdisciplinarytransferability, and suffer from insufficient dataquality and a resistance to meaningful datatracking and searching. Based on this prelimin-ary survey, it appears that these limited func-tionalities are perceived by users as a seriousdisadvantage in terms of data search, overview,analyzing, transmission as well as makingappropriate and informed decisions for diagno-sis and treatment of mental disorders.Moreover, the lack of a system that can trackthe quality of a service aggravates insufficiencyin resources and contributes to ineffective ser-vice distribution.

2. Despite the availability of reliable and wide-spread clinical descriptions, diagnostic guidelinesand genetic biomarkers included in clinicalguidelines (e.g. Clinical PharmacogeneticImplementation Consortium) and drug labeling,rates of adherence among clinicians to thesestandards remain low. One of the most seriousbarriers to their utilization, beside nonfunc-tional EHR and paper-based documentarians,are time limitations, insufficient human resour-ces and ‘expert-centric’ attitudes. Mental healthpractitioners are required to undertake inter-views, e.g. personal, family and health history,and conduct comprehensive assessments, e.g.mental status, physical health, risk assessmentsand clinical scales, to reach the most appropri-ate decisions for a possible diagnosis and treat-ment plan, all within short consultations (about45min for first contact and 15min for follow-ups). As a result, very high caseloads and timepressure may contribute to lapses in history-taking, potential medical errors and unreliabletreatment decisions. The other challenge facedby all countries is scarcity of specialist humanresources. The number of specialized and gen-eral health workers dealing with mental healthis grossly insufficient. Globally, the mediannumber of mental health workers is 9 per100,000 persons, but there is extreme variation(from below 1 per 100,000 population in LMICto over 50 in HIC) [17]. Pressure on resourcesacross public services creates a powerful incen-tive for developing new ways of delivering careand support. Meeting rising demand andensuring that more people have access totreatment and support are significant futurechallenges for the mental health sector. In con-trast to any other medical area, where diagnos-ing and treatment plan are based on highlysensitive and specific tests and technical

DIGITAL PSYCHIATRY 17

innovations, psychiatry is still positioned as a‘medical art’, in which initial clinical impressionsthat are made by professionals usually duringfirst interview or observation of a patient, oftenpredetermine final decision in terms of diagno-sis and treatment choice. The digital innova-tions bringing diagnostic and treatmentstandards into clinical practice and increasingpatients and their representatives’ involvementin care plans would transform current mentalhealth services to be more ‘patient-centric’ andassure the improvement of service quality viatracking systems following compliance withrequired clinical and psychosocial standards forpatients’ needs.

3. Public expectations of mental health services,and how they might interact with them, arechanging. Through greater use of technology,the public are becoming more engaged and bet-ter-informed consumers of their own healthcare.By making the most of the opportunities pre-sented by e-mental health and digital innova-tions, we can address some of the biggestfuture resource challenges facing the mentalhealth sector – for example, the costs of servicedelivery, workforce issues, access to servicesand continuity of care. As traditionalapproaches struggle to meet this overwhelm-ing need, new technologies are required toexpand access and improve health outcomesat lower costs. Our firm belief is that qualityimprovement in mental health services, includ-ing their ability to provide support and effect-ively complete their responsibilities foridentification, prevention and management ofmental disorders, would significantly improve ifthe highest international standards and instru-ments orientated on achieving better outcome,health recovery and human rights protectionare digitalized and implemented in everydaypractice. This would be performed via existinge-approaches, including electronic record sys-tems, online-based applications and mobileapps, particularly those facilitating sharedtherapeutic decisions between clinicians andservice users. Achieving this goal is cruciallydependent upon assuring that mental healthservices routinely use the same standardswhen providing treatment and support to peo-ple with mental disorders and psychosocial dis-abilities or needs.

4. The new concepts contributing to more preciseand personalized mental healthcare through theintegration of IT innovations, digital phenotyp-ing, genetic approaches and cloud-based facili-ties and technologies should improve the

management of mental disorders. The mainbenefit of such an approach is the expectedshift of current, traditional mental health practi-ces towards preventive healthcare based onproactive assessment and screening programscombined with early intervention and treat-ment, instead of reactive disease treatment,and, as result, a reduced burden on patients,their social communities, and their healthcaresystems. The current IDMHN consortium hasproposed the joint action for development ofcloud-based Intelligent Platform for Research,Outcome, Assessment and Care in MentalHealth (i-PROACH) enabling the wide imple-mentation of standardized clinical processesand pathways in mental health. We believe i-PROACH will be established as a new inter-nationally trusted tool for addressing societalneeds for more precise and personalized diag-nosis, treatment and management of mentaldisorder through its innovative solutions,including clinical DSS (DocuMental software),algorithms on genetic data (as provided byBiobanks and genetic initiatives, for example U-PGx: Ubiquitous Pharmacogenomics http://upgx.eu/), digital phenotyping and artificialintelligence tools (Figure 1). In particular, the i-PROACH platform should promptly lead topatients receiving more standardized and evi-dence based care plans, less complications andless comorbidities whilst reducing treatmentcost by avoiding unnecessary or incorrect treat-ment medications, and provides transparentdata for monitoring and measuring outcomes,quality of care and services provided. By facili-tating the further integration of the i-PROACHplatform and its individual components withother evidence-based technologies (genetictest, neuroimaging, blood analyses etc.), thefuture development of personalized medicineapproaches in mental health will be also sup-ported in the long-term.

5. There is increased trust in cloud-based infrastruc-tures among healthcare providers and increasedawareness that existing infrastructures withinhealthcare services are insufficiently flexible forchanges and lack necessary functionalities toaddress current challenges with data quality anddata exchange. In particular, the quality, accessand interoperability of existing data collectedvia the majority of EHRs in mental health arefar from ideal, due to several limitations andbarriers. Generally, these data are not struc-tured, not trackable, content-poor, and lackingin standards and indicators. Several Europeaninitiatives, for example BBMRI and ELIXIR,

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facilitate utilization of shared infrastructuresand services, and provide data managementtechnologies in open cloud-based environ-ments, which contribute to reusable and qual-ity data and meaningful analytical value inmental health, especially if data are collected instandardized and well-structured way. Moreattention should be paid to high-quality (digi-tized and standardized), reusable (interoperableand real-time updated), and large multidiscip-linary (e.g. clinical, demographic, psychosocial,digital phenotyping, genetics) data collection,handling and access in international mentalhealthcare and services. It also requires compli-ance with regulatory processes, including datasafety, privacy protection in line with theGeneral Data Protection Regulation (GDPR)requirements and Digital Single Market policies,where appropriate. As the first stage, we areplanning to elaborate the strategy for process-ing data to European Open Science Cloud(EOSC) services to enable the i-PROACH imple-mentation process when integrating the i-PROACH platform with existing e-infrastructuresand cloud-based environments across EU coun-tries. We will establish dialog between actorsinvolved in official agreements and resourceallocation and proceed with legalization proc-esses to enable the integration of i-PROACHwith healthcare databases and systems; datahosting at local data storage services and fur-ther transfer of research data (anonymized orde-identified) to i-PROACH cloud.

6. Access and integration of health-related datafrom multiple sources create unprecedentedopportunities for increasing the quality of health-care by generating, integrating and managing

health data from heterogeneous sources whenhealthcare providers are enabled to share part oftheir data with the different stakeholdersinvolved in the provision of health services topatients. The important issues in the i-PROACHproject regarding the GDPR are principles forprocessing personal data, especially health-related data, consent management andanonymization, accountability and data govern-ance, data protection by design and default,data exchange, security measures and dataprocessors. We will analyze the impacts ofthese issues on the digitalization of health pro-fessionals’ workflows and sharing of sensitivedata across the EU, and will explore securitymechanisms like blockchain and new anonym-ization models like controlled access andimplement solutions which enable the manage-ment of information privacy and trust in thenetworks accordingly to the GDPR principles.We also aim to establish a data managementplan (DMP) to present rules and guidelines forthe management of personal sensitive andnon-sensitive data and ensure compliance withEuropean and national regulations includingdata security ethical issues. To support the datamanagement and processing within the i-PROACH platform, we intend to develop securecloud-based solutions, allowing users to runapplications processing sensitive data in asecure environment. It would facilitate collect-ing international or cross-border data into thesame data catalog with access to secure proc-essing environment, supporting efficient largeanalyses, required for research and administra-tive evaluations.

Figure 1. i-PROACH platform.

DIGITAL PSYCHIATRY 19

7. In the context of improving access to care andservice quality, WHO recommends the develop-ment of comprehensive community-based mentalhealth and social care services; the integration ofmental health care and treatment into generalhospitals and primary care; continuity of carebetween different providers and levels of thehealth system; effective collaboration betweenformal and informal care providers; and the pro-motion of self-care, for instance, through the useof electronic and mobile health technologies [9].A substantial and increasing proportion of peo-ple with mental disorders are being seen byGPs or in community-based settings and in pri-vate practice. All of these areas lack specificdigital platforms for mental health. We thusaim to provide comprehensive, integrated andresponsive mental health services in commu-nity-based and primary care settings. This canbe achieved by integration of the i-PROACHplatform with social and primary care servicesand by providing support to increase confi-dence and skills among non-specialized healthworkers in recognizing and managing mentaldisorders. The i-PROACH platform may contrib-ute to shifting the focus of care away fromlong-stay hospitalization in mental-health insti-tutions towards non-specialized health settings,with increasing coverage of evidence-basedinterventions (including the use of steppedcare principles, as appropriate) for priority con-ditions, and using a network of linked commu-nity-based mental health services (includingshort-stay inpatient care, and outpatient care ingeneral hospitals, primary care, comprehensivemental health centers, day care centers) to sup-port people with mental disorders living withtheir families and in supported housing. Thisstrategy will facilitate the resource savings andreorganization of mental health services byreducing administrative, human and time-related costs, and improving management andcare plans, including hospitalization length andnumber of visits.

8. The i-PROACH platform may provide uniqueopportunities for clinical research and scientificprograms and contribute to increased researchactivity at local, national and international levelsin mental health, particularly due to inter-national standards, and support data-searchingfacilities and possible interconnectedness withother interdisciplinary technologies. In line withthe Mental Health Action Plan 2013–2020 [9],i-PROACH may contribute to improvements inresearch capacity and academic collaborationon national priorities for research in mental

health. In particular, the i-PROACH platform isdesigned to collaborate with existing researchprojects, such as PerMed for the implementa-tion of systems and personalized medicine inEurope, the European Alliance for PersonalizedMedicine, and international organizations, suchas the Global Alliance for Genomics and Healthand the BBMRI and ELIXIR bioinformatics infra-structures, in order to ensure maximal impact.Furthermore, by accumulating large quantitiesof detailed data about individual patients andthrough the development of genetic and pre-dictive models, the i-PROACH may also supportinitiatives of biotechnology partners to collectcomprehensive data on the safety, efficacy, andeffectiveness of innovative medicines, and thedevelopment of new, personally ‘tailored’drugs. Due to the standardized and digitizedclinical workflow in mental health across world-wide countries we will also facilitate real-timesearch of potential patient participants forresearch studies, which should reduce costsand increase feasibility in practice. Overall, i-PROACH will conduct research in collaborationwith multidisciplinary teams with expertise,resources and research capacities to achievethe critical mass needed to complete theexpected research and move towards the com-mon goal of promoting the preservation ofhealth and preventing the onset of disease. Wealso aim to expand i-PROACH’s involvement inscientific and academic activities to becomethe most powerful, international platform forthe promotion of research in mental healthand for the more effective use of necessarilylimited resources. The i-PROACH platform alsoaims to support equity for countries with lowor middle income in obtaining resources, andto secure their involvement in research andconsortium programs.

9. Mental health strategies and interventions fortreatment, prevention and promotion must bebased on scientific evidence and best practice,and therefore should implement the principlesfor more precise and personalized approaches inroutine management and care of mental disor-ders. To achieve this goal, we are aiming toestablish a process of scientific validation for e-mental health innovations, including i-PROACHplatform considering the following sequencebefore full implementation: Feasibility/Pilot(Evaluating retention/acceptability, safety, satis-faction) followed by a Randomized ControlledTrial either against treatment as usual or anon-inferiority trial vs. an evidence-based inter-vention. An implementation feasibility study

20 E. MARON ET AL.

could be the final part of the process in orderto assess large-scale feasibility. Furthermore,the improvements in mental disease manage-ment and mental healthcare outcomes thatresult from the transformation of traditionalmodels of care, patient journeys and clinicalpathways to the new personalized and pre-dictor-based digitized clinical workflows shouldbe evaluated by applying health impact andthe cost-effectiveness analyses. This is particu-larly important considering the considerablesocial and economic burden due to mentalhealth disorders. As the first pilot the economicimpact of implementing personalized mentalhealth approach provided by i-PROACH will beevaluated in Estonian healthcare systems(Figure 2). With the Estonian National HealthInformation System (ENHIS) in place (used byall Estonian healthcare providers, who are obli-gated to forward medical data to ENHIS),innovative programs towards personalizedmedicine, a national digital prescription system,and an established state-of-the-art genomecenter, Estonia, with its modern and relativelysimple health system, is particularly suitable topilot i-PROACH in routine clinical practice andimplement it fully on a national scale. Duringthis pilot, we will be able to demonstrate andestablish interoperability between i-PROACHplatform and existing healthcare systems,including EHRs, ENHIS, the patient portal,digital prescriptions and the Estonian Biobank;and to elaborate models for 1) health impactanalysis: based on direct patient level out-comes (such as relapse rate and quality of lifewithin-normal) and indirect indicators (such as

hospitalization length, re-admission/presenta-tion rates), and 2) the cost-effectiveness ana-lysis: based on direct costs of using healthcareservices, costs for developing, implementingand maintaining digital solutions, and costs fortraining healthcare staff.

10. Despite the prioritization of mental health by theWHO as medical area which requires more atten-tion and transformation, this field is still signifi-cantly less funded by grant resources, such asEuropean Commission or EIT-Health, than, forexample, oncology or cardiology. Psychiatricconsortia aiming to bring innovations intomental health often face questioning attitudesin experts involved in application review. Thisis reflected by the low number of successfuland funded projects on digital mental healthled by psychiatrists. The project revision sys-tems need more transparent and fairapproaches, with better opportunity for bilat-eral feedback and communication on individualprojects. As recognition of this problem, EIT-Health recently made a very significant steptowards improvement in their evolution pro-cess of submitted applications by increasingdecision based on project face-to-face hearingrather than based on remote expert review.Such changes give more chance to researchteams to explain project details in better waythan it might be done in writing form. Ourmultidisciplinary consortium has the requiredskills and expertise through world�s leading sci-entists in clinical research and ICT/eHealth toexplore and exploit innovations and strategiesfor digital personalized mental health. We areconfident that i-PROACH will improve

Figure 2. i-PROACH implementation into routine practice.

DIGITAL PSYCHIATRY 21

personalized mental health and care beyondthe current ‘state-of-the-art’ – it is ambitious,but also realistic and achievable. To increaserecognition of our consortium and its potentialin innovation and research for mental health,we will establish closest possible collaborationswith key stakeholders in healthcare and pro-mote our vision through proactive involvementin calls and actions related to digital and per-sonalized medicine.

11. Due to digitalized and integrated internationalstandards for assessment and treatment of men-tal disorders, i-PROACH represents a promisingtool for teaching, education and revalidation ofmental health workers and medical students. Inparticular, we aim to implement educationactivities tailored to the needs and interests ofthe target groups. The activities would include:(1) consortium website: to provide the resultsof the i-PROACH progress, information aboutupcoming conferences the IDMHN will attend,and available publications; (2) policy events: toincrease collaboration with authorities and pol-icy makers, etc., (3) peer-reviewed publications:to facilitate the distribution and uptake of i-PROACH results; (4) presentations at conferen-ces: to present research results at establishedinternational conferences by professional soci-eties; (5) guidelines: we plan to develop i-PROACH guidelines to guide clinicians in pre-venting certain outcomes, such as relapse,somatic risks, adverse side effects of drugs,drug-drug interactions, etc. by using platform.Planned educational materials will be availableto all interested parties through the website.The following training activities to facilitate theinnovation and implementation of i-PROACHfor personalized mental health will include: (1)i-PROACH User Manual; Tutorials; and Videos;(2) i-PROACH online training: we aim to designan online training class consisting of modulesbased on the most common user activities ofthe i-PROACH platform. Healthcare providerswould be able to sign up for free and try outthe different functionalities without having animplemented platform available in their institu-tion. This will help future users to prepare forthe implementation of the platform in theirwork and will also help interested future usersto get a feel for how the platform may posi-tively influence their clinical workflow.Furthermore, the service users involvement(PPI) in the further development and imple-mentation of i-PROACH platform will be alsoencouraged in order to optimize theacceptability.

12. To maximize the impact of the i-PROACH projectwe will establish strategy based on stakeholderinvolvement and target-group orientation, includ-ing patient representatives, particularly GAMIAN,authorities and policy makers, etc. The proposedtarget-group orientation will allow us to defineand implement measures geared to the specificneeds of the different groups. The i-PROACHplatform will implement dissemination activitiestailored to the needs and interests of the tar-get groups. As the main focus of disseminationis on the distribution and uptake of results,most activities will focus on the scientific com-munity, healthcare providers and policy makers.Through an established international network,we will introduce i-PROACH solutions to keystakeholders and thus to expand engagementwith our project. In particular, the members ofteam and partners are involved in scientificand management boards at several inter-national organizations and thus may help tomaximize the visibility of i-PROACH project andplatform to broad audience. We also aim toincrease collaboration with patients, authorities,professional organizations (such as EuropeanPsychiatric Association, World PsychiatricAssociation, World Federation of Societies ofBiological Psychiatry, World Congress onMedical Informatics and others), policies mak-ers, eHealth experts in plans and strategies fori-PROACH. The eHealth and ICT-oriented tech-nology and business meetings will also help tointroduce the platform and facilitate contactwith potential major industry and investors. Weaim to develop a detailed plan for horizontaland vertical knowledge dissemination, toensure that awareness of the i-PROACH projectis disseminated widely and freely availableamong local and international stakeholders,including governmental and non-governmentalorganizations, commercial companies, research-ers, clinicians, policy makers and the public.Additionally, in close collaboration withEuropean and national medicine agencies theIDMHN also reviews and adjusts the list ofmedications registered for mental health totheir local availability in order to aid theadequate choice of medicines via i-PROACHplatform for each involved country.

13. Digital solutions have the potential to reorganizecurrent healthcare systems by bringing new serv-ices, influencing policies impacting personalizedhealthcare approaches, and developing reim-bursement that would be favorable for theimplementation of personalized medicine.Conversely, such strategy in mental health

22 E. MARON ET AL.

would prevent numerous serious adverseevents and thus save resources, which willlower the costs of the respective healthcaresystems. The complexity of the scenariorequires thorough health economical evalua-tions, such that the results of i-PROACH wouldnot only provide conclusive evidence ofimproved patient outcomes but also documentsimultaneously the costs of healthcare.Thereby, i-PROACH should further facilitate theincorporation of personalized health care meas-ures into national and international guidelinesand change clinical practice. The economicimpact of i-PROACH is potentially huge – earlyidentification of at risk individuals (preventionof disease), personalized approach and increaseadherence to intervention, early and effectivetreatment will reduce burden of disease, com-plications associated with chronic diseases aswell as related treatment and hospitalizationcosts, thus reducing the burden of morbidityand mortality to society. For example, a Danishrandomized controlled trial of CYP2D6/CYP2C19 found that pharmacogenetic testingin patients with schizophrenia significantlyreduced costs among the extreme metabolizers(poor metabolizers and ultrarapid metaboliz-ers), including costs of psychiatric care, primarycare services and pharmaceuticals. This studydemonstrated an excess of costs in extrememetabolizers ranging 177–239% higher than‘normal’ metabolizers; when using genotype-guided treatment, however, this excess costwas reduced by 23–48% [18]. In addition, arecent multicentre, randomized controlled trialshowed that compared with usual care, anintervention based on personal predictors ofrisk of depression implemented by GPs is acost-effective strategy to prevent depression[19]. Thus preliminary evidences of cost savingsprovides further support to the implementationof digital solutions into clinical guidelines andpractice. Therefore, the detailed cost-effective-ness analyses will also need to convince healthinsurance companies and related organizationsto reimburse and support the clinical applica-tion of the new strategy and digital innovationsin mental health. Considering that i-PROACHplatform potentially has a very broad imple-mentation range, covering different ‘marketareas’ and involving a diverse community ofusers, it must also be competitive priced andqualify for the same level of reimbursement. Inparticular, the business scheme for DocuMentalis planned as a subscription-based licensingmodel, where price calculation will take into

account the number of users, utilization ofservices, regional economic conditions, copy-rights and permission expenses, upgrades,technical support and profit. However, themain principle of DocuMental and otherlicensed components of the i-PROACH platformis in immediate value for mental healthcareand users, where expenses on subscription ofdigital innovations should be significantly lessthan total outcome and benefits raised by theirimplementation in everyday clinical practice.

6. Summary

It is widely recognized and generally accepted thatexisting standards for identification and manage-ment of mental disorders, including diagnostic andtreatment guidelines as well as polices for humanrights protection should be applied and strictly fol-lowed world-wide. The current international consor-tium aims to implement i-PROACH principles intoeveryday practice within a range of geographicallyand socioeconomically diverse countries in order toimprove identification, management and preventionof mental disorders via digitized and personalizedapproaches, and to contribute to overall improve-ments in mental health services. The breakthroughapproach of i-PROACH is in coupling these standardsand eHealth innovations, which results in improved,effective, integrated and responsive mental healthsectors through enabling the implementation ofstandardized instruments in practice. This approachhas a high potential to address current needs inmental health, to become more transparent in termsof service access and quality, to be more beneficialin terms of outcomes and burden reduction, moreproactive in terms of connection with other areas,and more responsive in terms of collaboration withauthorities and organizations representing the inter-ests of people with mental disorders and psycho-social disabilities.

Disclosure statement

Prof. Eduard Maron is the founder and CEO of Documentalltd. Prof. Siegfried Kasper and Prof. David Nutt are mem-bers of advisory board of Documental ltd. None of theseadvisors or other members of the IDMHN, expect of EM,have shares in Documental Ltd. This manifesto was devel-oped by joined effort of IDMHN based on the best interestfor mental health area and public under fair and profes-sional principles.

ORCID

Diego Hidalgo-Mazzei http://orcid.org/0000-0002-2693-6849David Nutt http://orcid.org/0000-0002-1286-1401

DIGITAL PSYCHIATRY 23

Dina Popovic http://orcid.org/0000-0002-6413-1400Alessandro Serretti http://orcid.org/0000-0003-4363-3759Florence Thibaut http://orcid.org/0000-0002-0204-5435Jonas Eberhard http://orcid.org/0000-0003-0364-2626

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