Table 3.

Building block

Enabler	Element description	Element example	Country
Category: planning and enablers 1. Strategy and Investment
Vision	− National, regional, and local stakeholders have a strong understanding of personalised health care and a clear vision for its short-, medium-, and long-term implementation − This vision is cocreated with and communicated to all relevant stakeholders − It covers the full patient journey (e.g., from prevention and health promotion to end-of-life and palliative care) and considers all aspects of personalised health care (e.g., technological, geographical, financial), with the aim to improve patient and health system outcomes	Central NHS leadership for digital health and health data [83] − Central vision and leadership of digital health initiatives is coordinated via the NHS − Seven data/digital innovation hubs have been selected by HDRUK across the UK to improve data curation and use to boost patient care, improve outcomes, and deliver fair value on the use of data − The hubs each focus on either a specific disease area or data type, e.g. oncology, ophthalmology, RWD, merging vision and expertise to deliver enhanced data sets that will drive research, innovation, and improved outcomes	UK
Leadership	− Decision-makers at all levels of the health system are equipped with the right knowledge and skills to drive value-based personalised health care while empowering implementation actors − The right stakeholders are empowered to make decisions relating to personalised health care, building trust in their decisions and in the value of personalised health care	Estonian EU presidency in 2017 [84] − Digital health was a priority of the Estonia presidency of the EU Council from July to December 2017 − The Estonian Ministry of Social Affairs and ECH Alliance launched the “Digital Health Society Declaration”: a call for action to achieve the digital transformation of health care systems	Estonia
Implementation strategy	− An explicit and action-oriented strategy has been defined to implement or build personalised health care but remains flexible enough to reflect the dynamic environment of health care − Clear timelines are based on the current state of the health system, in order to follow ambitious but pragmatic steps that reflect the maturity of different countries or regions − Collaborative governance and change management are at the core of the strategy − Potential challenges and disparities that could lead to uneven implementation of or access to personalised health care are systematically considered, to ensure equitable health	Australian Implementation Plan for the National Health Genomics Policy Framework [85] − The Australian government developed a National Health Genomics Policy strategy − This is supplemented with an implementation plan that includes prioritised actions, roles, time frames for completion and lead responsibilities	Australia
Funding	− Short- and long-term government investment is in place for personalised health care, covering the full spectrum of health (i.e., from prevention to end-of-life care), health services, health products and data − Investment is targeted towards areas that deliver proven value or transformative innovation (e.g., genomics), de-commissioning obsolete technologies and leveraging efficiencies (e.g., generic headroom) to ensure sustainable funding − Some funding is specifically dedicated to limit disparities (e.g., for underserved patients)	Investments in Singaporean IT network [86] − Singapore has made significant investments into IT/cloud infrastructure and computational capacity − Government spending amounts to SGD 15 million annually for EHR capacity maintenance and expansion − A new cloud-based health care information model, hCloud, is being launched, costing SGD 37 million in the first 10 years − The government are testing the commercialisation of health data *** Australian Genomics Health Futures Mission [87] − There has been significant funding and investment to improve genomic medicine in Australia, amounting to AUD 500 million for the 10-year initiative	Singapore *** Australia
Communication	− A simple, human communication strategy around personalised health care helps to make the case for this and emphasise the benefits to patients and society, fostering buy-in and involvement − This clarifies the scope of personalised health care and illustrates it into easy-to-understand components − This raises awareness and expectations around how to conduct and be involved in personalised health care at a societal level, connecting the dots between strategy and implementation	Data Saves Lives by the European Patients Forum [88] − Data Saves Lives is an initiative, hosted by the EPF secretariat, to address the challenges and opportunities relating to health data − The core of the initiative is the development of an informative web platform that will provide lay-language information for patients and citizens who need neutral, understandable and comprehensive information on the topic of health data	Europe
2. Patient awareness and empowerment
Health literacy	− People are empowered to understand and act with regard to their own health, partaking in shared decision-making based on appropriate levels of information − Patients and patient associations understand and advocate the scope of personalised health care and their roles within it, and are involved broadly and early in formal and informal processes − Awareness and education campaigns are in place to cover specific personalised health care topics (e.g., prevention and lifestyle, screening and prevention, role of digital health, ethical aspects of genomics)	Health Literacy Europe and National Alliance for Health Literacy [89] − The Health Literacy Europe and National Alliance for Health Literacy combine 60 organisations ranging across patients, providers, insurers, academia and industry − This network aims to advance European health literacy and education on personalised care *** Citizen referenda in Switzerland − Citizens can call constitutional and legislative referendums − They are consulted on proposed laws several times a year and are accustomed to partaking in the dialogue and having a say	Europe *** Switzerland
Education and skills	− People − including patients and patient associations − are equipped with the knowledge, skills and tools to cocreate the personalised health care ecosystem − Through training programmes, courses, interactions with HCPs, tutorials, and other means, they can collaborate with other stakeholders to define what works for them (e.g., using digital vs. non-digital means, opting in vs. opting out) − They are empowered on topics including but not limited to data donation and sharing, informed decision-making and/or providing consent appropriately − Patient representatives and associations are involved broadly and early in formal processes and decision-making for health care (e.g., regulatory, HTA), as well as informal consultations	Widening Digital Participation programme [90] − The Widening Digital Participation programme was set up to help the millions of people who lack the confidence and skills to access and use digital health services and information and benefit from their convenience − From 2013 to 2016, more than 200,000 “digital muggles” (e.g., older people, socio-economically deprived and excluded groups) and 8,000 local digital champions/volunteers were trained − 54% of learners in need of non-urgent medical advice said they would now go to the Internet before consulting their GP	UK
3. Workforce
Awareness	− HCPs and other professionals fully understand the scope of personalised health care − HCPs are encouraged to take a holistic, multimodal approach to their patients' health − Other professionals (e.g., data analysts, care workers, coaches) are increasingly involved in people's health and well-being − Awareness and education campaigns are in place to ensure that all professionals have a clear view of how they should operate within personalised health care	Personalised Medicine and Novel Therapies MSc by UCL [91] − UCL Personalised Medicine and Novel Therapies Masters programme offers advanced education for HCPs and other professionals − It builds awareness sharing on a breadth of personalised health care topics	UK
Education and skills	− HCPs and other professionals (incl. regulators, government stakeholders, other agencies) are fully literate in digital health, health data and new technologies − Coordinated educational programmes (e.g., medical training, dedicated masters and PhD courses) ensure that the right knowledge and skills are being developed, nationally and locally − Additional hands-on, practical training is available as part of continuing medical education, covering medical software, devices, technologies, best practices in data collection, and other topics	Training in IT and EHR system at NorthShore University for 150,000 h [92] − NorthShore University invested USD 7.5 million to train staff on new digital systems in the first 3 years − This facilitated quick uptake and high completion compliance *** Informatics Training for Global Health programme from the Fogarty International Center [93] − The Fogarty International Center has supported informatics research training in low- and middle-income country institutions in partnership with US institutions and investigators − It has funded several collaborative research and training programmes in Latin America and played a significant role in expanding the informatics workforce based on the health and informatics needs in Latin America	USA *** Latin America
Capability planning	− The number and capabilities of current professionals involved in personalised health care are mapped, to determine which capabilities are critical versus preferable (incl. people and financial resources) and how prevalent these are (inc. in urban vs. rural settings) − A dedicated capacity plan and forecasting are in plan to provide a short-, medium-, and long-term view of the multidisciplinary workforce (e.g., collaborating across therapy areas) and the different means of ensuring their education/skills (e.g., via training programmes)	Support for the health workforce planning and forecasting expert network (SEPEN) [94] − Expertise and knowledge sharing on improving health workforce is to be driven through SEPEN, a European expert network on planning and forecasting, to increase expertise and knowledge sharing for the health workforce − It aims to develop expert networking to structure and exchange knowledge, map national health workforce policies in all EU countries, foster the exchange of knowledge and good practices on health workforce through European workshops, and provide tailored support to some countries on national implementation of health workforce planning	Europe
4. Collaboration
Knowledge networks	− Best practices for personalised health care are shared openly, systematically, and efficiently through individual, institutional, or geographical collaborations (involving all relevant stakeholders) − Expert and consultation networks are used to systematise best practice sharing − Publicly-available and widely disseminated findings and recommendations	European Institute of Innovation and Technology Health Initiative [95] − The European Institute of Innovation and Technology Health initiative connects 90 partners from public and private organisations − The aim of this network is to accelerate innovation and development of health services by sharing best practice and investing EUR 2 billion	Europe
Innovation hubs	− Centres of excellence, innovation hubs, incubators and/or accelerators are in place, well-funded and able to provide support and advice to innovate in personalised health care − Digital health solutions and other innovations in personalised health care are iterated, tested, and disseminated through the hubs − There is strong reliance on best practice sharing and agile methods of working (e.g., piloting and scaling)	Cross-sector accelerator CoLab in Denmark [96] − The CoLab accelerator aims to facilitate market entry of MedTech solutions, via collaboration of industry, communities, and hospitals at 6 local development and test facilities − Patients and carers are surveyed for their views and participate in development *** Boston Health Tech Innovation Hub [97] − The Boston Health Tech Innovation Hub has supported 1,221 start-ups of which 12% in health care − It has invested USD 3.2 billion in health tech start-ups − Partners include Boston University, Northeastern University, and UMass Boston, and with investors Techstars, Healthbox, and Masschallenge − For example, the hub supported start-ups to aggregate health data or manage respite and home care services	Denmark *** USA
Multiparty bidding for health services	− Private enterprises, patient associations, and other non-government entities can bid to provide personalised health care services and/or products (e.g., telehealth, EHR provision, chronic cancer support) − New service providers are seen as trustworthy and value-adding, and are not kept away from or penalised in contracts for personalised health care provision	Openness to any suitable provider to support health system in Valencia [98] − Any willing stakeholders (incl. private entities) can engage in the health system and provide services − Transparent KPI requirements (e.g., surgeries per day, waiting lists, access, patient satisfaction) are shared with interested parties, to allow any qualified stakeholder to participate	Spain
Health system partnerships	− Partnerships with all relevant stakeholders (e.g., health providers, insurers, NGOs, patient associations, pharma and med tech companies, tech companies, etc.) are in place, run smoothly, and are well received − These partnerships − incl. but not limited to public-private partnerships − have a clearly defined purpose, responsibilities, governance, standards, and communication pathways to enable collaboration, use of best practice, and data sharing − The responsibilities of public and private entities within these partnerships are well established	Productive development partnerships in Brazil [99] − The aim of productive development partnerships is for public institutions to have the production technology to receive technology from the private sector, to develop the critical inputs, and jointly produce with the private sector in order to deliver the final product to the Unified Health System − This provides an annual economy of about USD 1.5 billion to the Brazilian Government, of which USD 50 million are for medical devices *** Public-private partnership at Genomics England − Genomics England 100,000 Genomes is a repository of genomic test results, to enable genomic and personalised therapies − Initially public, it is now a successful public-private partnership *** ASPiRATION project [100] − ASPiRATION is a genomic profiling research project for 1,000 Australians with newly diagnosed metastatic, non-squamous, non-small-cell lung cancer − The project is funded by the Australian government's Medical Research Future Fund and by Roche − It will be conducted by the Australian Genomic Cancer Medicine Centre, the Australasian Lung Cancer Trials Group, and the National Health and Medical Research Council Clinical Trials Centre	Brazil *** UK *** Australia
5. System incentives
Incentives for patient participation	− A comprehensive set of transparent system incentives and nudges is in place to enable personalised health care by improving adherence/compliance and strengthening patient involvement − These tailored incentives span across all settings of care and are continuously monitored and adjusted as needed to ensure their positive impact − Rewards for contribution/participation can include: declining copayments for adherence, subsidies when immunisation targets or preventative behaviours are met, etc.	Wellth/Mount Sinai patient compliance program [101, [102] − Wellth, a digital health company based in New York, has developed a system that provides patients with daily financial incentives to improve their compliance with drug regimens − The patient sends a photo of their medication in their hand, to verify that they are successfully taking it, and receives a financial reward − Supported by a grant from Health 2.0 and the New York City Economic Development Corporation, the Mount Sinai Health System has enrolled 12 patients in a pilot study with start-up Wellth	USA
Incentives for value-based care	− A comprehensive set of transparent system incentives is in place to enable personalised health care by improving the quality/targeting of care provided by HCPs and other professionals − These tailored incentives span across all settings of care and are continuously monitored and adjusted as needed to ensure their positive impact − Incentives can support: following appropriate referral pathways (e.g., appropriate referrals to genomic testing), collaboration in multidisciplinary teams, decreased waste (e.g., reducing overtreatment and unnecessary interventions, focusing on high-value care) − Incentives can include: bonuses, non-financial support, etc.	System incentives for HCPs if enrolling patients into a qualified disease management programme [103] − Disease management programmes provide a proactive, multicomponent approach, integrating care across diseases and their complications, to reduce variation of care − HCPs adhere to programme protocols and educate patients about self-care − Lower copayments are offered for enrolled patients for their medications *** Cross-party collaboration for grants − In the UK, funding bodies are asking academia to demonstrate that broader stakeholders (e.g., patients, clinical associations) are involved in research and initiatives	Germany *** UK
Incentives for data	− A comprehensive set of transparent system incentives/nudges is in place that enables personalised health care by improving the amount, quality, and sharing of health and health-relevant data − These tailored incentives span across all settings of care and are continuously monitored and adjusted as needed to ensure their positive impact − Incentives can support completion and quality of EHRs, discounts/cashback for use of digital tools, or mobile devices with regular data input	Human Brain Project's medical informatics platform [104] − The Human Brain Project is a global open-source platform that allows hospitals and research centres worldwide to share medical data − Access to the platform is contingent upon sharing of own data, promoting a collaborative approach to data collection and analysis	EU
Incentives for innovation	− A comprehensive set of transparent system incentives is in place for innovation, investment and R&D in personalised health care priorities (e.g., digital tools for elderly) and frontier digital technologies (e.g., AI, blockchain, Big Data) − Incentives are available to both large companies and start-ups, to build up traditional areas and innovative tech ecosystems (e.g., incentivise PPPs that support personalised health care values)	Bio Convergence Technology Laboratory [105] − The Bio Convergence Technology Laboratory is an ecosystem where SMEs, joint ventures, start-ups and big enterprises coexist in Songdo International City − The goal was to create 6,000 jobs across 250 companies, including 90 SMEs and 160 venture and start-up companies in bio, beauty, and medical devices − Designated as Korea's first free economic zone for foreign investors doing business in the area	South Korea
Category: health information and IT infrastructure
6. Data legislation, guidance, and standards
Legal and ethical frameworks for data	− Evidence-based legal and ethical frameworks are in place to support the effective management of health and genomic data, addressing data privacy and sharing, primary and secondary uses of data for research and personal purposes, security and protection, personal and societal impact of data and new technologies, etc. − These legal frameworks are rigorous enough to provide clear guidance but remain flexible enough to be updated regularly in response to the dynamic nature of technology − Legal frameworks are aligned nationally and, where possible, internationally, building on best practice from across the globe	HMA EMA Joint Big Data Taskforce [106] − The HMA EMA Joint Big Data Taskforce assessed regulatory and ethical acceptability of big data analyses − It aims to increase legal and ethical transparency around health data standardisation, quality, sharing, and use *** National Digital Care Act in Switzerland [107] − The Swiss National Digital Care Act covers the governance of EHRs, apps, and health data to harmonise security and privacy policies − It ensures that patients can safely access records ***	Europe *** Switzerland *** Finland
		Finnish Act on the Secondary Use of Health and Social Data [108] − The purpose of the Finnish Act on the Secondary Use of Health and Social Data is to facilitate the effective and safe processing and access to the personal social and health data for steering, supervision, research, statistics, and development in the health and social sector − A second objective is to guarantee an individual's legitimate expectations as well as their rights and freedoms when processing personal data
Data standards	− Clear, aligned standards are in place to govern the full data journey − from data collection, interoperability, linkage, quality, analysis, and storage − These include: cross-stakeholder common data models and standards for consent, cleaning, use; open-access standards and certifications for maximum interoperability and integration; standardised and widely used personal health identifiers; principles of clear identification of the data source, etc. − These standards are re-assessed regularly, in line with the fast-paced development of new technologies	Observational Medical Outcomes Partnership Oncology [109] − Observational Medical Outcomes Partnership Oncology was launched in 2017, with its first outputs published in 2018 − It aims to transform data into a common format with common terminology across oncology and entails strong collaboration with academia − It incorporates EMRs histology records and diagnostic/treatment/outcome data	Global
Governance and process for access	− Clear, aligned governance and transparent processes are in place to govern access, transfer, and sharing of health data records − These include: patient access to their own health data; secondary use of data for institutional and personal uses; national and cross-border collaboration that does not require localisation of data hosting (e.g., cloud-based systems that may be based in other countries); governance of NGS data outcomes; etc. − Data controllers are allowed to use, share and/or transfer data within their use − The aim is to limit cybersecurity or de-anonymization risks, including clear protocols for deviations	Buurtzorg nursing admin and data software [110] − Buurtzorg is a modern IT system that enables online scheduling, documentation of nursing assessments and services, billing and sharing of information within and across teams *** Dubai Health Authority Dashboard [111] − The Dubai Health Authority has a dashboard of public health data for the government, based on existing databases and information completed by HCPs − This provides visibility on disease trends *** MEGA 1 Million Genome Initiative [112] − Launched in 2018, the MEGA 1 Million Genome Initiative is a collaboration mechanism between 21 Member States and Norway, with the potential to improve disease prevention, allow for more personalised treatments, and provide a sufficient scale for new clinically impactful research − The aim is to have least 1 million sequenced genomes available in the EU by 2022	The Netherlands *** United Arab Emirates *** Europe
Secure software	− Systems, processes, and technologies are in place to securely link, transfer, and share data (e.g., for clinical and research purposes) − These facilitate the collection and use of data by being user-friendly and intuitive, while guaranteeing the security of collected information throughout its journey between users	National Bio Big Data [113] − Five major big data platforms were built as the foundation for bio-health innovation is data − The core platform is the “National Bio Big Data,” launched to collect genomic, medical, and health information from up to 1 million volunteers, and to use the collected information to develop patient-customised drugs *** TIBU digital health system [114] − Initially focused on tuberculosis treatment, TIBU integrates the ministerial facilities and administrative offices with National Health Information System (DHIS/2) providing real-time data on patients, treatment, and outcome, drug availability, lab inventory, and real-time payments made to the patients using the mobile payment platform M-PESA	South Korea *** Kenya
7. IT infrastructure
IT architecture and capacity	− A clearly defined architecture is in place for digital services, including models of information and common lexicon/terminology (e.g., to promote interoperability) − There is a joint commitment to develop a common IT architecture and adopting set standards, including openness to cloud-based systems for storage − Advanced computational capacity and bandwidth are established to manage complex operations at optimal speeds and store/process growing amounts of data − Interoperability and sharing are at the core of the architecture, with IT used to connect different systems − standardised unique personal health identifiers (or other mechanisms to link different data sets covering a single person) are used across health and other systems, with a clear understanding of ethical and privacy implications	Danish unique personal health identifiers [115] − In Denmark, unique personal health identifiers are issued to all citizens at birth alongside a secure web ID for online EHR access − The identifier links patient details to one of the 15 interoperable EHR systems and alerts patients by e-mail if an HCP views records − There are financial incentives for HCPs to use the identifiers, as well as centrally funded technical support *** IT and EHR system at NorthShore University [116] − NorthShore University has developed a clear IT strategy and architecture plan, based on experience with stand-alone IT systems, to develop an integrated solution	Denmark *** USA
Monitoring of data, IT, and processes	− Data processes and IT delivery are assessed regularly (e.g., digital maturity, interoperability) to ensure that the right services and technologies are in place − KPIs are used to track performance of digital systems and processes (e.g., data quality) − Outputs from these assessments are used to make evidence-based recommendations for digital implementations and future decisions − Relevant agencies champion data interoperability and standards	eHealth Digital Service Infrastructure [117] − Launched in 2015, it is intended to allow doctors to share electronic patient summaries and issue prescriptions across borders − The first transfers took place in 2019, between Finland and Estonia	Europe
8. Data sources and software
Registries and genomic data repositories	− High-quality, long-term data sources (e.g., registries, genomic data sets) provide detailed health data to help personalise health care for individual patients and populations − These data extend beyond health care, to provide a comprehensive picture (e.g., geographic, socio-economic, outcomes) − Data sources are interoperable to ensure breadth, depth, and effective use of data − There is national and international collaboration to enable complete information sharing	Genomics England 100,000 Genomes [118] − Genomics England 100,000 Genomes is a repository of genomic test results, to enable genomic and personalised therapies − The database was launched in 2012, with the final patient recruited in 2018 − Its aim is to enable new scientific discoveries, medical insights, and advanced diagnostics *** Estonian Biobank [119] − The Estonian Biobank was launched in 2000 − Its aim is to collect information on the health of the Estonian population and their genes, study this cohort scientifically from both genetic and medicals aspects, and use the data obtained to improve national health standards − In 2018, the first biobank participants started receiving their personal genetic reports	UK *** Estonia
Electronic health records	− EHRs are in place across all settings of care, with high adoption, completion rates, and quality − Records pull from numerous health-related sources (e.g., care providers, devices, claims, prescription data) and non-health-related sources (e.g., geolocalisation) − Patients and HCPs have access and training to amend, consult, and use the data “live” − EHR data can be used for health management and decisioning, as well as research (e.g., using anonymised data) − A coordinated function leads on EHRs, data, privacy, and knowledge sharing, with clear governance and pathways that allow access and integration with non-health data − Constant quality, consent, and security surveillance of EHRs and other sources of health data (e.g., via a security operations centre) is in place	National EHR in Denmark [120] − The centralized electronic database of its citizens' medical records goes back as far as 1977 for basic records and back as far as 2000 for detailed histories − Approximately 98% of primary care physicians have access to the system, including all hospital physicians and all pharmacists *** National EHR in Denmark − A nationwide “birth-to-death” electronic health record system is in place for nearly every citizen	Denmark *** Estonia
Integration of new technologies for data	− User-friendly, intuitive tools and software are in place to capture, aggregate, clean, enhance, and analyse data − These softwares collect RWD in existing health systems and beyond (e.g., wearables, media) and are designed for interoperability and sharing, with tools progressively replacing more traditional means of data collection (e.g., paper, voice recordings) − There us a robust understanding of potential applications of current and future data technologies, analyses, and outputs (e.g., clinical decision support, health system dashboards), with constant evaluation and testing of new technologies to improve the full data lifecycle (e.g., AI to clean and enrich data, GIS to visualize data, SaMD) and/or integrate across domains/sources at the superordinate level (e.g., via EHRs)	Health information system HealthConnect [121] − HealthConnect involves tools given to patients to manage their own health and experience (e.g., virtual consultations) − This includes digital medical refill requests, virtual consultations, AI support, etc.	USA
Category: health services
9. Public health and prevention
Prevention and health promotion	− Prevention is seen as an essential part of the health continuum, with efforts targeting primary, secondary, and tertiary prevention as part of the overarching health strategy − Screening, early detection, health promotion, follow-up for disease progression/relapse, awareness campaigns, etc. are targeted towards populations at risk in order to improve health-related behaviours and foster a healthy society	LC-SCRUM − Japan [122] − LC– SCRUM– Japan is a genomic screening project conducted by the National Cancer Center Japan in cooperation with medical institutions and pharmaceutical manufacturers across the country − LC-SCRUM − Asia is an industry-academia collaborative cancer genome screening project for lung cancer patients, which uses state-of-the-art genetic testing technology to simultaneously examine multiple genetic changes that cause lung cancer (5 institutions in Taiwan and 161 in Japan)	Japan/Asia
Population health management	− Population health management is seen as an essential part of overall health management methods, leveraging data, risk stratification, predictive analytics, and other public health methods to identify at-risk populations − Outputs from these techniques (e.g., progress reports, health system dashboards) are used to plan and evaluate the provision of health across the population, to ensure optimal outcomes within allocated resources	Kaiser Care Management Institute [123] − Each of Kaiser's geographic regions select care management priorities (such as diabetes, asthma, heart disease, or depression) based on the health needs of its members − The Care Management Institute develops tools each region can use to develop care management strategies, then ships them to local implementation teams, which tailor care management programmes to their populations	USA
10. Personalised health infrastructure
Advanced diagnostics	− Basic diagnostic testing/screening/imaging/point-of-care infrastructure are in place (incl. at primary care) to enable the accurate, timely diagnosis of patients − More advanced tests (incl. NGS) are offered routinely and early in the process (i.e., for triage), as needed, and used in both clinical/patient applications and research purposes − Interpretation support is provided for multimodal testing (e.g., clinical decision support, AI, visualisation) − Clinical guidelines and prescription practices are in place to support the appropriate use of basic and advanced diagnostics and how their results should be interpreted and used (e.g., sequencing across tumour type for tumour-diagnostic health products, use of genomic data and personal medical history to inform HCP decisions), supported by appropriate standards	Norwegian Cancer Genomics Consortium − The Norwegian Cancer Genomics Consortium began using NGS to test cancer biopsies for personalised medicine treatments in 2012 − The second phase of the project has received funding (USD 7 million) from the BIOTEK 2021 programme	Norway
Remote monitoring	− Remote monitoring and telehealth are widely used to support the continuous management and support of patients, providing the bridge between traditional settings of care and community care − These technologies help reach at-risk or remote groups (e.g., rural patients) and support personal choices (e.g., preference for home care)	Babylon Health telemedicine solution [124] − Babylon Health provides accessible preventative consultations and diagnostics (e.g. RR, pulse) via an app − It offers integrated point-of-care tests and referrals between app, local GPs, and other providers	UK
Personal devices and mHealth	− Personal devices (e.g., wearables, apps) are widely used to support prevention, communication, treatment, recovery, constant monitoring, and data collection, (e.g., RWD collection) − These help reach at-risk or remote groups (e.g., rural patients) and support personal choices (e.g., home care via telemedicine) − The consumer health data that are collected from these devices can be integrated in broader health decisioning	Wearable devices and monitoring (e.g., smart watches, Fitbits, speedometer) in Dubai [125] − Dubai has promoted the use of various self-assessment apps, data sharing with clinicians, and devices linked with EHRs − It is still lacking one consolidated pathway, but there is rapidly growing uptake by patients	United Arab Emirates
Integration of new technologies for health	− New technologies are assessed and tested regularly to improve personalised patient journeys, from prevention to chronic care (e.g., telehealth, apps, AR/VR) − These are fully integrated into the patient health journey, rather than added on to certain parts of the pathway − Predictive techniques are used to support local health systems in planning care provision − Clinical decision support and AI are used to help clinicians apply best practice and provide optimal patient care, by providing timely information to clinicians, patients, and others to inform decisions about health care	Artificial intelligence at Xiangya Hospital [126] − Xiangya Hospital uses data collected from patients (e.g., scans, photos, notes, etc.) to inform and test an AI algorithm for dermatology, then launched the first dermatology Internet hospital licensed to operate online in China − It launched an interactive app that enables patients to upload their medical history, including pictures, ahead of an appointment, to free up time for the actual diagnosis when visiting a clinician − It has conducted a “smart cervical cancer screening” programme, which assists in examining 60 million women annually by reducing the time it takes to evaluate the involved Pap test slices ***	China *** Canada
		Canadian Personalized Healthcare Innovation Network − The Canadian Personalized Healthcare Innovation Network brings the Canadian health care system together to use the power of data to improve health outcomes for Canadians − The goal of their Lung Kick Start Program is to determine, through RWD, the sequencing of testing and treatment that produces the best health outcomes for specific lung cancer patients
11. Patient-centric care model
Patient-centred health infrastructure	− High-quality, reliable health infrastructure is in place that can be accessed and navigated by all, with the right care centres and specialists available in the vicinity (e.g., hub and spoke model) − Care consent frameworks strengthen patient understanding and efficiency − these can readily be amended, assigned, or revoked, and there is rapid and full access of agreed information to agreed parties after consent − The infrastructure enables evidence-based care for one, e.g. using dynamic labelling/patient-specific information/patient-relevant product information − Health management and treatment decisions are based on the most appropriate patient information (e.g., tumour sequencing based on sequencing rather than morphology) and consider outcomes that matter to patients	Ping An Good Doctor [127] − The Ping An Good Doctor is a one-stop health care ecosystem that caters to the needs of adults, the elderly, and children by appointing dedicated doctors to conduct one-on-one consultations − It also acts as “health butler” that integrates the services in medical and health care sectors, i.e. by developing an electronic health profile, customising a physical check-up plan, compiling medical reports, tracing abnormal health indicators, and managing weight for users	China
Pathways for patient-HCP communications	− Two-way communication pathways are in place between patients and their families, and HCPs and other professionals, to support shared decision-making based on appropriate levels of information (e.g., outcomes that matter to patients) and empower patients − The full range of the patient support network can be involved as needed (incl. family, friends, carers, patient associations) − Continuous communication, coordination, and data flows are systematically enabled between patients and their HCPs, and embedded into care pathways and care models − Patients are confident in using digital communication pathways, with alternatives available if digital is unsuitable for them (e.g., SMS, face-to-face)	Lybrate app [128] − The Lybrate app provides patients with a one-click emergency support system, search tool for nearby ambulance services and book appointments with best doctors − It allows patients to digitally store and manage their medical records (incl. past prescriptions, lab reports, allergies, etc.) on their smartphone and share with their doctors easily	India
Monitoring of health and care	− Personalised health care delivery is assessed via the full range of outcomes (e.g., events, re-admissions but also QoL, PROs, etc.) − Global, national, and local standards are established and used as benchmarks to preserve quality of health delivered − KPIs are used to track the quality of care delivered and the outcomes for patients, remove low-benefit practices, and ensure equitable access to health − Outputs from these assessments are used to make evidence-based recommendations for improvement in care processes	World Health Organisation Global Accelerated Action for the Health of Adolescents [129] − In 2015, the WHO/UNAIDS published the Global standards to improve quality of health-care services for adolescents − Many countries have used the Global Standards to adapt and adopt them nationally (though these can be time-consuming) *** Martini-Klinik in Germany [130] − The Martini-Klinik, a specialist prostate cancer clinic, systematically measures the quality of its care using outcomes that are most relevant to patients − These data are shared with the health care professionals at the clinic to continually revise and improve care − The clinic consistently performs better than the German national average in terms of treatment outcomes for patients with prostate cancer *** Santeon hospital network in the Netherlands [131] − Santeon, a Dutch network of 7 leading teaching hospitals, implemented value-based health care by defining the right metrics to improve outcomes, initiating a strict and simultaneous cadence of improvement cycles, and sharing results to accelerate improvements − It has achieved reductions of nearly 30% in unnecessary inpatient stays and up to 74% in the rate of reoperation due to complications in breast cancer patients	Global *** Germany *** The Netherlands
12. Integrated care coordination
Integrated care coordination	− Care is interoperable across all sectors of health (e.g., community care and medical specialists, public and private providers, within and across regions, across siloed specialties), applying to care plans and care models − General prevention management and care delivery are controlled by a coordinated function, with a traceable entry point into the system (e.g., GP) and clear information flows − Transparent and efficient referral pathways enable seamless multidisciplinary care − Community care/extramuralisation is recognised and a full part of health management − This is informed by consultation with patients and patient associations	Integrated diabetes care system in the Netherlands [132] − The Dutch model for integrated care has been pioneered in diabetes and led to significant improvements in patient outcomes − It relies on having a single point of entry into the programme and adopting a coordinated, multidisciplinary approach, with GPs strictly following national standards − Bundle payment for diabetes has been in place since 2007	The Netherlands
Pathways for HCP-HCP communications	− Digital tools, apps, and infrastructure are in place between HCPs (e.g., primary vs. secondary care, across different specialties), as well as other health-related professionals (e.g., coaches, nutritionists, psychologists, social workers) − These ensure that exchanges about people's health are timely, secure, and seamless amongst and across all stakeholders (e.g., via chats, telehealth) − This is informed by consultation with patients and patient associations [133] [134]	Doximity app [135] − Doximity is a leading professional medical network, with half of US physicians as members − It allows physicians to use their iPhone, iPad, Android device or computer to securely collaborate with other physicians, review career opportunities, and stay current on the latest medical news − Physicians can send and receive patient medical information through the platform	USA
Category: health products (i.e., medicines and therapeutics, diagnostics and other medicinal products)
13. Legislation, policy, and guideline
Legal and ethical frameworks for genetic and -omics	− Evidence-based legal and ethical frameworks are in place to govern the appropriate use of gene editing and -omics (e.g., genomics, proteomics, biomics, etc.) − These legal frameworks are rigorous enough to provide clear guidance but remain flexible enough to be updated regularly in response to the dynamic nature of technology, society, and innovation − These cover topics such as: genetic discrimination; genomics privacy; genetic testing and tests; IP; etc. − Legal frameworks are aligned nationally and, where possible, internationally, building on best practice from across the globe	Australian National Genomic Policy Framework and Implementation Plan 2018–2021 [136] − The Australian National Genomic Policy Framework and Implementation Plan covers regulatory and legal approaches to genomics implementation − Key chapters cover genomic integration into the national health system, policy frameworks, and strategic priorities (e.g., person-centred approach, workforce, financing, services, data)	Australia
Legal and ethical frameworks for digital health	− Evidence-based legal and ethical frameworks are in place to govern the appropriate use of digital health (e.g., mHealth, wearables, and related technologies) − These legal frameworks are rigorous enough to provide clear guidance but remain flexible enough to be updated regularly in response to the dynamic nature of technology, society, and innovation − These cover topics such as: use of new technologies (e.g., AI); ownership of data collected or shared via digital health; health signal and response accountability, etc. − Legal frameworks are aligned nationally and, where possible, internationally, building on best practice from across the globe	WHO legal frameworks for e-health [137] − The WHO legal frameworks for e-health ensure that appropriate legislations are at the heart of e-health to enable and support the provision of EHRs, e-prescriptions, etc. − This includes non-binding guidance based on the second global survey on e-health − There is a focus on ethical and legal aspects of privacy in health care	Global
14. R&D and clinical trial models
Support for R&D	− Continuous public and private funding is available for R&D in health − Research, where health products are shown to bring value, is actively translated into clinical practice through investment from all relevant parties − Incentives are in place to specifically accelerate the translation of research into clinical practice above and beyond incentivising R&D	Australia's National Medical Health and Research Council − The National Medical Health and Research Council, which issues research grants, has recognised the issue around poor translation of research into clinical practice and actively incorporated a specific KPI in its annual report to improve on these figures − It has adopted various mechanisms to accelerate translation for specific research projects	Australia
Digital, patient-centric trials	− Clinical trials are conducted more robustly through the use of best practice, including the involvement of patients/patient associations in the design, running, and wrap-up of trials − Digital and other technologies (e.g., Internet of Things) are used to monitor patients, run trials efficiently, and obtain a broader set of data	DNAnexus [138] − DNAnexus offers a cloud-based genomic data collaboration platform and launched a clinical trial solution that integrates the genomics data obtained from NGS into clinical studies − Participants' DNA samples are sequenced and uploaded to the platform for analysis − Study clinicians can monitor the progress of analyses − The platform is also integrated with a clinical trial management system to retrieve and store genomic results − Bioinformaticians can test and validate their pipelines and reports associated with the trial who are likely to respond to the treatment	Global
New clinical trial models	− New models of clinical trials (e.g., single arm, basket, and adaptive trials) are tested and rolled out in response to the unique characteristics of certain personalised health care products − These models are used by both private and public researchers to evaluate health products − They are deemed relevant in regulatory, HTA/P&R and/or pricing frameworks and models	Note: like the outcomes-based models, this can be tricky to convey as it is drug-related information; alternatively, could we use a collaboration or consensus paper on new trial models in order to avoid singling out specific products?	−
15. Regulatory frameworks
Innovative regulatory frameworks using new data sources	− Regulatory frameworks are in place that provide transparency, guidance, and evidence requirements for new medicines (incl. molecularly guided therapies), technologies (e.g., NGS), software (incl. clinical decision support), etc. − These pathways offer rigorous guidance for products being evaluated, with flexibility to be updated regularly due to the dynamic nature of health and health products − The regulatory methods reflect the nature of the solution and evidence (e.g., RWD, modelled data), accounting for different levels of evidence and leveraging new types of data (e.g., digital end points) − There is clear guidance on situations in which RWD is useful in regulatory decision-making (incl. clinical context, sources of data, study designs, quality/relevance, etc.) − Informed and validated patient/patient association input is incorporated across the regulatory frameworks	FDA 21st Century Cures Act, Dec 2016 [139] − The 21st Century Cures Act includes regulatory policies intended to speed patient access to new and breakthrough medical devices − It has a focus on discovery, innovation, delivery, support, and financing of new cures and devices − It entails the provision of USD 500 million over 9 years for the FDA to implement new laws *** FDA and EMA Patient Engagement Cluster [140] − FDA and EMA have patient and consumer clusters established across the regulatory process − They have institutionalised regular collaboration and exchange processes with clusters as well as between FDA and EMA on an institutional level − They developed a joint publication about the value and how-to of patient engagement	USA *** Europe
Integrated regulatory frameworks	− Regulatory frameworks are in place that cut across health products and technologies, looking at the full continuum of care and/or parallel technologies (e.g., NGS, clinical decision support, etc.) − Frameworks cover new technologies such as NGS, software as medical device, clinical decision support, etc.	Note: as far as we can tell, this is not being implemented anywhere in full (the closest being the review of CDx with individual drugs)	−
16. Innovative payment models
Innovative HTA/P&R pathways	− Pricing, reimbursement, and access pathways are in place that provide transparency, guidance, and evidence requirements for new medicines and therapeutics, to reinforce sustainable health systems − HTA methods and processes reflect the nature of health products/technologies (e.g., digital solutions, products for small populations, phase 2 products, etc.), uncertainty, and available evidence (e.g., RWD, QoL, PROs), to ensure that value can be accurately assessed in a timely manner − Pathways balance uncertainty and new sources of evidence with the need to provide timely access to innovation − These pathways offer rigorous guidance for products being evaluated, with flexibility to be updated regularly due to the dynamic nature of health and health products − Integration of informed and validated patient/patient association input across regulatory pathways	Therapeutic value of conditional innovation [141] − The Haute Autorité de Santé is considering a new metric (therapeutic value of conditional innovation) which would apply to technologies with immature evidence bases − It could replace the ASMR and would be re-evaluated periodically, as real-world evidence and further clinical trials become available − For CAR-Ts, it has accelerated the frequency of assessments in order to review impending clinical trial data and RWD from the requested CAR-T registry *** German Digital Care Act, 2019 [142] − In 2019, Germany passed a law allowing doctors to prescribe digital apps with health benefits, which can be reimbursed by the country's health insurance system − The Federal Institute for Drugs and Medical Devices will check for issues such as data security, data protection, and functionality, and after that apps will be provisionally reimbursed by statutory health insurance	France *** Germany
Integrated HTA/P&R pathways	− Pricing, reimbursement, and access pathways are in place that cut across health products and technologies, and consider broader societal value − These cover the full spectrum of care rather than a specific product or intervention, and/or consider their full impact on patients, carers, and societies (i.e., including outcomes, QoL, direct and indirect costs, intangible costs, ethical, legal, and organisational aspects, etc.)	Dental and Pharmaceutical Benefits Board [143] − The Swedish Dental and Pharmaceutical Benefits Board is a health technology assessment agency that sets the pharmacy purchase price level and pharmacy margin for reimbursed pharmaceuticals − It adopts a wide societal perspective, considering all costs and revenues for treatment and ill health including lost productivity, work loss, and time loss for the patient and their relatives, etc.	Sweden
Monitoring of funding and models	− Health funding (e.g., as a share of GDP), financing mechanisms (e.g., outcome-based reimbursement, population health models, etc.) and procurement approaches are routinely evaluated, to ensure appropriate investment in the health of populations while maintaining health system sustainability − KPIs are used to track performance of health systems and impact of funding (e.g., ROI, access, outcomes, etc.) − Outputs from these assessments are used to make evidence-based recommendations for investment decisions − Best practices from other countries are reviewed regularly to learn from best practices	Dubai Health Authority procurement KPIs [144] − The Dubai Health Authority has established a set of KPIs to monitor funding, procurement, and provision of personalised health care, with guidance for all parties	United Arab Emirates
Outcome-based payment models	− Data-enabled, innovative payment models are in place for medicines and therapeutics, diagnostics and medical devices, digital solutions and other health products, to ensure that health products are part of a sustainable health system − These include: conditional reimbursement, outcome guarantee, payback scheme, free initiation, etc. − Transparent and holistic payment and procurement processes are used to obtain health products, with long-term investment, while focusing on quality, services, and sustainability of supply − These models are based on data, reward outcomes, and support innovation	Managed entry agreements with the Italian Medicines Agency [145, 146] − Through the Italian agency AIFA, conditional reimbursement agreements are in place for most innovative medicines, whereby payment is achieved where agreed outcomes are met − The aim is to ensure access to new medicines for all patients while ensuring health system sustainability − Specific monitoring registries are in place to evaluate managed entry agreements and provide new, innovative treatments *** Philips and Sanger risk-sharing agreements [147] − Philips and Atrium Health's Sanger Heart and Vascular Institute signed a risk-sharing agreement − Led through the image-guided therapy devices business, the 12-month agreement links Philips' advanced imaging technology capabilities to the achievement or avoidance of critical outcomes for patients with peripheral vascular disease	Italy *** USA
Integrated reimbursement approaches	− Innovative payment models cut across medicines and therapeutics, diagnostics and medical devices, digital solutions, and other health products − These cover the full spectrum of care rather than a specific product or service, and/or a population rather than a specific patient − These include: staggered payment, value-based bundles, portfolio deals, accountable care organisations, etc. − Transparent and holistic payment and procurement processes are used to obtain health products, with long-term investment, while focusing on quality, services, and sustainability of supply − These models are based on data, reward outcomes, and support innovation	Saudi Vision 2030 transformation [148] − As part of its Vision 2030, Saudi Arabia's health system is moving towards clusters that operate like accountable care organizations − These will have capitated payment models	Saudi Arabia

HDR, health data research; RWD, real world evidence; ECH, European alliance connected health; EHR, electronic health record; EPF, European Patients Forum; HCP, health care professionals; GP, general practitioner; HTA, health technology assessment; UCL, University College London; KPI, key performance indicator; NGO, non-governmental organization; AI, artificial intelligence; PPP, public-private partnership; SME, small and medium enterprises; HMA, heads of medicines agencies; EMA, European Medicines Agency; EMR, electronic medical record; NGS, next-generation sequencing; GIS, geographic information system; SaMD, software as a medical device; RR, respiratory rate; AR/VR, augmented reality (AR) and virtual reality (VR); QoL, quality of life; PRO, patient-reported outcomes; IP, intellectual property; P&R, pricing and reimbursement; CDx, companion diagnostics; ASMR, improvement of medical benefit (amélioration du service médical rendu); CAR-T, chimeric antigen receptor T; GDP, gross domestic product; ROI, return of investment.