1、Governance Frameworksin Digital Mental HealthW H I T E P A P E RN O V E M B E R 2 0 2 2In collaboration with Deloitte ContentsForewordExecutive summaryIntroduction1 Governance frameworks in digital mental health2 Implementer insightsOne Mind PsyberGuide,USAMental Health Commission of CanadaAustralia

2、n Commission on Safety and Quality in Health CareNew Zealand Ministry of Health3 UpLink innovators in youth mental healthConclusionContributorsEndnotes3457101112141618222324Cover:Deloitte BrandSpace image Inside:Gettyimages/Klaus Vedfelt;Gettyimages/Alvarez;Gettyimages/Halfpoint ImagesDisclaimer Thi

3、s document is published by the World Economic Forum as a contribution to a project,insight area or interaction.The findings,interpretations and conclusions expressed herein are a result of a collaborative process facilitated and endorsed by the World Economic Forum but whose results do not necessari

4、ly represent the views of the World Economic Forum,nor the entirety of its Members,Partners or other stakeholders.2022 World Economic Forum.All rights reserved.No part of this publication may be reproduced or transmitted in any form or by any means,including photocopying and recording,or by any info

5、rmation storage and retrieval system.Governance Frameworks in Digital Mental Health2ForewordIn 2018,the World Economic Forums Global Future Council on Neurotechnologies set out to understand the potential uses and ethical implications of digital tools for the treatment of mental ill health.This work

6、1 surfaced two insights:Technology holds the potential to fundamentally change the way mental well-being is addressed.A paucity of frameworks and roadmaps grapple with their ethical deployment.Subsequently,the World Economic Forum has collaborated with Deloitte to identify the gaps in governance sur

7、rounding mental health digital tools.It was felt that without appropriate regulation,the potential benefit of these technologies would not be realized because consumers,funders and providers lack confidence in their ability to select safe,high-quality tools.As the COVID-19 pandemic spread,the need f

8、or governance in this space became more urgent rates of depression and anxiety were spiking around the world,lockdowns were preventing in-person meetings with providers,and innovative,digital-first solutions looked more essential than ever.After analysing nearly 200 examples of novel technology use

9、in mental health with at least 10,000 users/downloads and interviewing thought leaders around the world,the Forum published the“Global Governance Toolkit for Digital Mental Health”in collaboration with Deloitte in April 2021.The toolkit,piloted with the New Zealand Ministry of Health,was designed to

10、 equip governments,regulators and independent assurance bodies with a roadmap of what“good”looks like in digital mental health and to“improve the accessibility,quality and safety of services that support all members of society to meet their desired emotional,social and psychological potential”.Four

11、years after this journey began,the world looks profoundly different:COVID-19,greater attention from regulators and an ever-evolving innovation landscape have altered what we know and what should be done.Recognizing this,we have returned to the work to assess these changes and shed light on the curre

12、nt state of digital mental health regulation via interviews with those who piloted the toolkit,those crafting their own policies and mental health innovators.Governance Frameworks in Digital Mental HealthNovember 2022Stephanie Allen Leader,Global and Australia Healthcare Sector,Deloitte,AustraliaShy

13、am Bishen Head,Platform for Shaping the Future of Health and Healthcare,World Economic ForumGovernance Frameworks in Digital Mental Health3Executive summaryGlobally,mental health concerns are both common and undertreated.Accessing mental health services is not a simple demand and supply curve.For in

14、dividuals who live in areas with mental health clinicians,barriers to accessing mental health care remain.These barriers include,but are not limited to,stigma,cost or access to reimbursement models,privacy concerns,a preference for dealing with problems independently and time constraints.Digital men

15、tal health services,such as those delivered by mobile phone or web-based platforms,have the promise of delivering more affordable care,expanding the reach and accessibility of services and designing new treatment models that meet the needs of the current and future generations.But digital mental hea

16、lth is not straightforward,and new technology is substantially disrupting approaches to how mental health conditions are identified,diagnosed,treated and supported.Telemedicine is offering care whenever and wherever it is needed through phone,video,email,chatbots and even gaming.Cognitive artificial

17、 intelligence(AI)is creating supportive digital interaction.Big data is unearthing a new understanding of the biopsychosocial factors.And brainmachine interfaces,which directly connect human consciousness with computers,are all promising to push the boundaries of what is possible.A dramatic increase

18、 in the creation of digital mental health services has occurred in the past 10 years.At the same time,governments,clinicians,large corporations and consumers have been expressing concerns about the safety,quality,efficacy,privacy and application of AI in these services and the extent to which they a

19、re safe.In 2018,the World Economic Forums Global Future Council on Neurotechnologies set out to understand the potential uses and ethical implications of digital tools for the treatment of mental ill health and collaborated with Deloitte to design a Global Governance Toolkit for Digital Mental Healt

20、h.The COVID-19 pandemic created a mental health crisis of unprecedented scale,triggered by social isolation,widespread unemployment,worries over contracting the virus,insomnia,social media exposure and the rising death toll.This accelerated the move towards the adoption and implementation of digital

21、 tools for mental healthcare.It also created a renewed urgency to develop and implement governance and regulatory frameworks to deliver clinical efficacy,access,privacy and data protection,as well as fairness,transparency and accountability.The toolkit,published in 2021,was designed to outline a way

22、 forward and provide recommendations for policy-makers,funders,developers,service providers and users.It became a fundamental resource that countries could lean on to start building their digital mental health roadmap.The work on the state of digital mental health regulation continues today,via inte

23、rviews with those who piloted the toolkit,those crafting their own policies and mental health innovators.This White Paper sheds light on the current regulation and highlights four case studies of entities that are leading the way in regulating the tools.Their emerging standards provide much-needed g

24、uidance for service developers and providers to incorporate privacy policies,data transparency and health information security in digital mental health frameworks and applications.This is only the beginning of the digital mental health journey.The regulatory structures of the future must be as dynam

25、ic and flexible as the advances they govern.Governance Frameworks in Digital Mental Health4Introduction1 1The life expectancy of individuals living with mental ill health across the globe is significantly reduced compared to those living without a mental ill health condition.For the estimated 1billi

26、on people living with mental ill health,such as depression,anxiety,personality disorders,schizophrenia and substance abuse,life expectancy is 10 to 30 years2 lower than that of individuals with typical neurological development and functioning.3 This statistic is further exacerbated by suicide,which

27、the World Health Organization(WHO)has estimated as taking one life every 40 seconds.4 Half of mental illnesses begin by the age of 14 and 75%by the mid-20s,drastically impacting early stages of social and emotional development,health,education and employment.5Tragically,these numbers are drawn from

28、pre-COVID-19 data,which may have pushed the prevalence of the two most common conditions depression and anxiety up by 25%globally.6 This toll is not only personal,but economic:the direct and indirect costs of mental ill health are estimated at 4-6%of global GDP(gross domestic product),more than the

29、combined burden of cancer,diabetes and respiratory disease.The Lancet Commission on mental health has estimated that by 2030,the worldwide cost of mental illness will reach more than$16 trillion annually as a result of lost or low output.7Mental ill health is undoubtedly a global challenge of our ti

30、me.Current models of care,care pathways and supporting systems are inadequate to address the growing burden.The way mental ill health is addressed must be radically rethought to ensure every person in need can access support that is safe,high quality,affordable and appropriate to their circumstances

31、.In every society,without exception,the gaps in access to affordable quality treatment and care are significant.This ranges from approximately 10 to 48 mental health professionals for every 100,000 citizens in high-income countries to 0.26 to 2 for every 100,000 citizens in low-income countries.8 De

32、spite the disparity,everywhere in the world today,there simply is insufficient mental health support available to those in need.While COVID has undoubtedly had a detrimental effect on global health and well-being,there have been some silver linings.These include a global increase in attention to the

33、 importance of mental health along with an explosion of innovative solutions backed by an unprecedented level of funding.Governments took emergency measures to loosen regulation on the delivery of telemedicine and e-health,maintaining and increasing access to mental health support.In addition,govern

34、ments and large employers now offer new services designed to build resilience and protect the well-being of citizens.Yet these heralded changes also raise concerns.As the number of digital tools rapidly increases in an environment without sound regulation,it has become more difficult for consumers t

35、o know what“good”looks like.In the current paradigm,low-quality digital tools may advertise false claims without evidence of clinical efficacy,or cut corners when it comes to data protection and privacy.Not only does this create an unsafe experience for the user,it also damages the entire ecosystem

36、by undermining trust in credible solutions.Governance Frameworks in Digital Mental Health5Recognizing this,the World Economic Forum Disruptive Technologies in Mental Health project developed the“Global Governance Toolkit for Digital Mental Health”.The toolkit was designed to outline a way forward an

37、d provide recommendations for policy-makers,funders,developers,service providers and users to answer several questions:What disruptive technologies offer the promise to augment,supplement and scale behavioural models of care,and bridge gaps in the access to care?What principles and standards underpi

38、n the decision to call a product clinically effective,safe and ethical?Who is best positioned to make these decisions?How can these products be regulated responsibly without stifling innovation?Four years after this journey began,the toolkit has been revisited,interviews with those piloting standard

39、s have been conducted,and work with a new tranche of innovators from around the world has been undertaken to understand what good governance comprises in practice and what is on the horizon.Several new insights came out of this work:Increased attention and decreased stigmatization of mental ill heal

40、th has been a windfall,but short funding cycles and changing political priorities can make systems unsustainable without significant foresight and longer-term commitment.Governments are dedicating far more resources to ensuring digital connectivity is universal,helping to abate concerns about digita

41、l inequity for the most vulnerable populations.Digital literacy and readiness must be considered not only for users,but for clinicians and funders who may be sceptical of changing long-established practices.Regulatory bodies do not necessarily have to be government-owned;excellent examples of not-fo

42、r-profit bodies doing the same work now exist.Comprehensive regulation and rigorous standards can be detrimental for new entrants into the market who may not have the expertise,time or resources to meet all requirements.Tiered standards in line with entrant size and proposed service should be consid

43、ered.Solutions must be designed with equity in mind.Innovations are commonly developed with only a single language,excluding immigrants and already marginalized populations.People with lived experience should be central to the entire designbuildtestoperate process.The adoption of equitable design pr

44、inciples and a robust adherence to them are critical.Governance Frameworks in Digital Mental Health6Governance frameworks in digital mental health1Digital mental health governance frameworks exist in several jurisdictions and,in some instances,have been implemented across entire countries.Governance

45、 Frameworks in Digital Mental Health7What is digital mental health?BOX 1Digital mental healthA broad term that encapsulates e-mental health while including other technologies that help improve consumers mental health and overall wellness.Disruptive digital mental health Innovative technology-based s

46、olutions that significantly change the way mental health and wellness are identified,diagnosed,treated and supported.They include emerging or mature technologies that could change the traditional way of doing business.e-mental healthUsing the WHO definition of e-health as a basis,e-mental health can

47、 be defined as the use of information and communication technologies for the provision of mental health services.Self-guided treatment applicationsVirtual assistants and chatbotsDisruptive digital mental healthOnline support groupsForums,blogs,podcastsOnline assessmentsVirtual reality to facilitate

48、training and awarenessDigital phenotypingComputational psychiatryNeurological interventionsGamified treatment experiencesSource:DeloitteEven as their level of maturity and stage of implementation vary,keeping up with the pace of digital mental health innovations has been a ubiquitous challenge.This

49、is further exacerbated by difficulty understanding whose purview these digital mental tools and their governance arrangements fall under.They incorporate elements of health data,medical devices,consumer goods,artificial intelligence(AI)and information technology.In addition,they frequently operate w

50、ithout constraint,in various countries with different legal jurisdictions and policy frameworks.To address some of these challenges,frameworks for digital mental health need to be equipped with a robust policy foundation and must be purpose-driven,evidence-based,goal-oriented and adaptable to provid

51、e assurance of the safety,quality and efficacy of the service without stifling innovation.Understanding what digital mental health is,and is not,has also been the topic of much debate.Digital mental health encompasses any services,accessed through a digital platform,that aim to prevent or treat ment

52、al health disorders or promote the well-being of people.It encapsulates e-mental health while including other technologies that help improve consumers mental health and overall wellness.These can include self-guided treatment applications,virtual assistants and chatbots,virtual reality facilitation

53、and gamified treatment experiences.Disruptive technologies in mental health are innovative technology-based solutions that significantly change the way mental health and wellness are identified,diagnosed,treated and supported.They can include digital phenotyping,computational psychiatry and neurolog

54、ical interventions.They are powered by innovation in the cloud,cognitive AI,big data,internet of things,blockchain,digital reality,robotics and quantum computing.Governance Frameworks in Digital Mental Health8While many good examples of digital mental health frameworks or standards exist around the

55、world(Figure 1),it appears that many still fail to account for the unique ethical challenges of AI in psychology.Evidence of Governance Frameworks in Digital Mental Health0%100%Digital mental health frameworks worldwide,2022FIGURE 1Source:Deloitte with Australian Bureau of Statistics,GeoNames,Micros

56、oft,NavInfo,OpenStreetMap and TomTom inputGovernance Frameworks in Digital Mental Health9Implementer insights2To go beyond frameworks and understand what deployment looks like on the ground,a series of interviews were conducted with four entities that are leading the way in regulating digital mental

57、 health tools:1.One Mind PsyberGuide,USA2.Mental Health Commission of Canada3.Australian Commission on Safety and Quality in Health Care4.New Zealand Ministry of HealthThese conversations sought to understand:What mental health services are provided How they have implemented digital mental health go

58、vernance frameworks What they have learned to dateGovernance Frameworks in Digital Mental Health10CASE STUDY 1One Mind PsyberGuide,USAMental health system overviewMental illnesses are a prevailing burden of disease in the United States,affecting about 50 million adults in 2020,with only just over 46

59、%receiving treatment and/or support.9 The US health system is comprised of providers of healthcare,insurance companies and patients.The types of providers within the mental healthcare ecosystem can include highly trained professional providers(e.g.psychiatrist),generalists(e.g.general practitioners)

60、,social service providers,advocates,a support network of caregivers,employers and community members.The US public health system is understandably complex to navigate due to the fragmented nature of its ecosystem,and consumers often struggle to access the mental health treatment they require.As with

61、many countries with the onset of the pandemic,the United States faced a sharp increase in mental ill health along with the demand for psychological services.The US Government will invest$300 million for youth mental services,10 integrating mental health and substance abuse treatment into primary car

62、e settings and investing in several programmes for providers to pursue behavioural health,including providing training and access to scholarships.One MindOne Mind is a global brain health not-for-profit organization based in northern California that accelerates collaborative research to enable all i

63、ndividuals facing brain health challenges to lead healthy,productive lives.It funds and supports scientific research to accelerate tools for diagnosis,prevention and treatment.One Mind established One Mind at Work in 2017 to help business leaders develop best-in-class workplace mental health program

64、mes that enable both employees and companies to thrive.One Mind PsyberGuideIn 2017,One Mind launched PsyberGuide and provided funding,a clear focus on the end user and guidance to progress its development.One Mind also provided connections with its users and with One Mind at Work to amplify and incr

65、ease the reach of PsyberGuide in the community and workplaces.Initially started as a research endeavour,PsyberGuide developed an accessible,digestible and bite-sized framework as a resource for general consumers attempting to navigate the proliferation of mental health apps and solutions.The One Min

66、d PsyberGuide is aimed at both clinicians and consumers who can access the not-for-profit website,which evaluates digital mental health apps and provides a publicly accessible pre-assessed library of apps.How does One Mind PsyberGuide work?PsyberGuide provides information on digital mental health pr

67、oducts to help consumers make informed decisions on the self-management of their mental health.The health apps have been assessed for their credibility,transparency and user experience(using the Mobile App Rating Scale),taking into consideration professional narrative reviews.The framework behind Ps

68、yberGuide includes clear guidelines on evaluating app objectives and efficacy,and ensuring strong privacy policies are established.PsyberGuide provides both app assessments and a pre-approved library.The products reviewed by PsyberGuide do not include endorsements;some products can score high or low

69、 in certain areas of assessment.PsyberGuide also provides resources on mental health and digital mental health for consumers.Advice for other jurisdictionsAn important realization is that digital mental health tools are but one solution.They are important innovations that can address access issues.B

70、ut thought should be given also to other barriers to access(e.g.cultural,language),structural changes,equity and the broad cultural context.One Mind at Work has been engaging employers at all levels from diverse regulatory and cultural environments,in both the public and private sectors.The conversa

71、tion about mental health needs to be elevated so people feel comfortable seeking the care they need when appropriate.Digital mental health is a segment of healthcare but is not comprehensive.Accreditation The current digital mental health app assessment process is based on publicly available informa

72、tion.PsyberGuide provides recommendations and guidance but has not yet put in place a mechanism for audit verifications of its findings.Governance Frameworks in Digital Mental Health11CASE STUDY 2Mental Health Commission of CanadaMental health system overviewMental illness is a leading cause of disa

73、bility in Canada,affecting 1 in 5 Canadians in any given year.11 The economic burden of mental illness in the country is estimated to be over$50 billion per year.12 The Canadian health system is funded by the federal Government,which distributes the funding to the provinces and territories.The amoun

74、t to each region differs,but this funding is not sufficient to cover mental health services in general.The cost remains an increasingly substantial barrier to access the required supports and treatments for those living in Canada.13Mental health support services are available to individuals through

75、primary healthcare providers(e.g.general practitioners)who offer referrals to psychiatrists,psychologists and therapists;through services provided by their employer(e.g.employee assistance programmes,insurance programmes for private cover);or through community groups.As in most countries,Canadas men

76、tal health system has been overwhelmed by the growing demand for mental health services largely driven by the pandemic.The shift from triage response to understanding prevention and sustainability in the long term is noticeable.Current state The Mental Health Commission of Canada(MHCC)recently launc

77、hed E-Mental Health Implementation learning modules,14 developed from its“Toolkit for e-Mental Health Implementation”,to support the teachings and establishment of e-mental health programmes.15 The toolkit echoes information gathered from the knowledge and experiences of practitioners and research g

78、roups,and includes an environmental scan and review of existing literature,interviews conducted with key informants in Canada and internationally,peer-reviewed research,templates and case studies.16 The online learning modules are free,self-directed and“designed to give mental health providers,manag

79、ers and leaders the knowledge and skills they need to integrate e-mental health into daily practice and support effective,person-centred e-mental health projects”.17 The e-Mental Health team has published several e-mental resources available on the MHCC website and recommended for immediate use.18 A

80、t the onset of the pandemic,the Canadian Government funded and developed Wellness Together Canada(WTC),a free online resource for those living in Canada to access mental health services online 24/7,including crisis response.The WTC portal connects those living in Canada seeking mental health and sub

81、stance use aid to“peer support workers,social workers,psychologists and other health professionals”.19 The portal also provides evidence-based information to help address mental health and substance use issues.Stepped Care 2.020 underlines the WTC portal,a mental health framework in partnership with

82、 Stepped Care Solutions across provinces in Canada.21 In 2021,the MHCC and the Canadian Agency for Drugs and Technologies in Health released reports on the uses and trends of AI in mental health.The MHCC is currently developing the first e-mental health strategy for Canada.An assessment framework fo

83、r mental health apps in Canada has been finalized,aligned to the eMental Health International Collaboratives(eMHIC)“Ethics and Law as Essential to e-Mental Health”position statement.22 An application standardization approach was taken,ensuring a suite of high-quality mental health apps are available

84、 to consumers.Key strengths and challenges of the mental health system The MHCC completed an extensive two-year project on recommendations to increase the access to psychotherapy in Canada.Canada has a“decentralized,universal,publicly funded health system called Canadian Medicare”where“healthcare is

85、 funded and administered primarily by the countrys 13 provinces and territories.Each has its own insurance plan,and each receives cash assistance from the federal Government on a per-capita basis.”23 Services are slowly being tailored for people from different cultural and/or linguistic backgrounds

86、to ensure they can access appropriate support for their mental health and well-being(e.g.the Centre for Addiction and Mental Health focuses on culturally adapted cognitive behavioural therapy,which has had good results).Assessment framework for mental health apps in Canada The framework encompasses

87、over 450 criteria based on seven standards:1)data and privacy;2)clinic evidence;3)clinical safety;4)usability and accessibility;5)security and technical stability;6)cultural safety,social responsibility and equity;and 7)enhanced data sovereignty.In particular,the“Cultural Safety,Social Responsibilit

88、y and Equity”standard includes content on key topics such as Indigenous data security and privacy,gender equity,representation from the Black,Indigenous and people of colour community in app content and visuals,usability and accessibility,and lived experience involvement in app development.Governanc

89、e Frameworks in Digital Mental Health12 The framework underwent a one-month public consultation period and was developed with 200 Canadian and international stakeholders from diverse backgrounds,including those with lived and living experience,policy-makers,government officials,app developers and de

90、signers,academic researchers and mental health service providers.The public review was conducted to reach a wider audience and provide transparency.With the final version completed,the MHCC aims to turn the assessment framework into an app review engine for app developers to assess their apps with t

91、he framework more easily;it will also develop public and provider platforms where the Canadian public and providers can go to access safe,quality and effective mental health apps.Barriers to implementation Not all provinces have the same coverage in terms of broadband/network support and some need t

92、o establish better network infrastructure to support digital mental health.Marketing and PR for digital mental health tools are critical to ensure the public,clinicians and practitioner know where to go to access services and resources.E-mental health service quality is currently lacking.Both consum

93、ers and service providers presently lack sufficient digital literacy.Providers need training to ensure they are comfortable providing a particular digital mental health tool.Overall design decisionsKey design decisions within the framework/toolkit were taken to ensure that it does not:Stifle innovat

94、ion and is balanced for grassroots players as well as large players/providers Penalize small/grassroots developers in small communities or rural settingsEvidence-based approach to the design of the digital mental health framework Baseline criteria were leveraged with the Organisation for the Review

95、of Care and Health Apps(ORCHA,implemented in the United Kingdoms digital health programme for the National Health Service(NHS),Ireland and the Netherlands)and the National Institute for Health and Care Excellence(NICE)Evaluation and Assessment for the Improving Access to Psychological Therapies prog

96、ramme;both of these frameworks are robust and have been validated and implemented in similar jurisdictions to those in Canada.Lessons were learned from the United Kingdom in terms of legislation adoption and general data protection regulation to ensure consumer data is sensitively managed in alignme

97、nt with robust policies/regulation on data consent for privacy.The ORCHA assessment was further tailored to the needs of the people in Canada to ensure that the diversity of community voices included Indigenous populations and that the lived experience testimonies were incorporated into the developm

98、ent of the framework.The framework was aligned to equivalent regulations and terms in Canada(e.g.the Pan-Canadian Health Data Strategy and the Medical Devices Regulations)to ensure the strategic visions for digital health correspond with mental health.Lessons learned Lived experiences should be inco

99、rporated;consultants/clinicians should receive training to understand that lived experience is expert advice.Broad consultation must take place with diverse stakeholders and with other jurisdictions(e.g.Australia,Denmark,Ireland,Israel,New Zealand and the United Kingdom)to share and learn from other

100、 experiences from which improvements can be made.Standardization should be ensured(where possible)at the national level.Accreditation The assessment framework for mental health apps in Canada has been finalized.An accreditation process for service providers is advisable now that the assessment frame

101、work for mental health apps in Canada has been developed.Governance Frameworks in Digital Mental Health13CASE STUDY 3Australian Commission on Safety and Quality in Health CareMental health system overviewOver 40%of Australians aged 16-85(about 8.6 million people)have experienced a mental health illn

102、ess at some point during their life,and 20%of the population has experienced a mental disorder in the previous 12 months.24 In 2020,a rise in psychological distress coincided with the COVID-19 pandemic.25 Within the Australian health sector,most mental health referrals are provided by a general prac

103、titioner to a mental health clinician,including psychiatrists and psychologists.These services may attract a subsidy under the Medicare Benefits Schedule.The Australian Government and state and territory governments deliver a range of mental health services that provide specialist care for people ex

104、periencing mental ill health.The Government funds a range of programmes and services,including income,social and community support,disability services,workforce participation programmes,and housing to people experiencing mental ill health.26 In February 2021,the final report of the Royal Commission

105、into Victorias Mental Health System handed down recommendations for a 10-year reform programme for mental health,focusing on a recovery-oriented approach to delivering mental health and well-being services.27Current state The 2019-2020 bushfires across Australia were described as unprecedented,affec

106、ting the lives,land,houses and livelihoods of thousands of people.28 It is well established that bushfires and other natural disasters have long-term psychological effects on the communities they impact.29 The Taking the Pulse of the Nation survey showed psychological distress pre-pandemic at 6.3%of

107、 the population,rising to 17.7%after the first wave of the pandemic(July 2020).30 Digital mental health(DMH)tools over the past decade have evolved rapidly and the number of options in the Australian market have increased substantially in recent years.These tools have the potential to reach communit

108、ies with reduced access to healthcare.The onset of the pandemic,among other factors,accelerated the uptake of these digital health tools.Until recently,no formal accreditation process for DMH services existed to assess against safety and quality standards,although mental health standards have existe

109、d for over 20 years.The Australian Commission on Safety and Quality in Health Care(ACSQHC)was tasked with developing standards for DMH services to support the safe and high-quality delivery of these services.Digital mental health framework The Australian Government Department of Health and Aged Care

110、 engaged the ACSQHC to develop safety and quality standards for DMH service provision.This includes supporting providers to ensure their services meet the expectations of service users and their support people.The ACSQHC has been working on the National Safety and Quality Digital Mental Health(NSQDM

111、H)Standards since 2017,recognizing the importance of using technology as an adjunct to traditional models of care.In 2019,the National Mental Health Commission(NMHC)released“Vision 2030”,setting out the“blueprint for a successful,connected mental health and suicide prevention system”that delivers be

112、tter outcomes for the mental health of all Australians.31 The ACSQHC partnered with service users,consumers,carers,families,clinicians,service providers and technical experts to develop the NSQDMH Standards,which were released in November 2020.The NSQDMH Standards include requirements for clinical a

113、nd technical governance,partnering with consumers and models of care.32Key strengths and challenges of the mental health system The ACSQHC was established in 2006“to lead and coordinate national improvements in the safety and quality of healthcare”.33 The NMHC was established in 2012“to monitor and

114、report on investment in mental health and suicide prevention initiatives and provide evidence-based policy advice to Government”.34 Both New South Wales and Victoria have seen record investments in mental health delivery;Victorias investment was realized after the final report of the Royal Commissio

115、n into Victorias Mental Health System.The Australian Government is investing$391.7 million,which builds on the historic$2.3 billion funding,in response to the Productivity Commissions inquiry report on mental health and national suicide prevention.35 This funding aims to improve access to high-quali

116、ty mental health,suicide prevention,and social and emotional well-being services for Aboriginal and Torres Strait Islander peoples and culturally and linguistically diverse(CALD)communities.36 There is significant variability in the delivery of quality mental healthcare;in some regions,mental health

117、care can be financially,geographically and/or physically inaccessible.37 Governance Frameworks in Digital Mental Health14 In some locations,access to DMH services is limited due to inadequate telecommunications infrastructure.This is particularly the case in rural and remote locations in Australia(e

118、.g.related to 4G and 5G coverage and internet connection stability to support virtual consultations or web-based services).National Safety and Quality Digital Mental Health Standards The NSQDMH Standards aim to improve the safety and quality of DMH service provision,and protect service users and the

119、ir support people from harm.The Standards“address key safety and quality risks for DMH service users”.38 They serve as a best practice guideline for service providers and developers to support quality assurance for DMH services.Providers include non-governmental,public or private organizations or in

120、dividuals who provide DMH services.Implementing the NSQDMH Standards is voluntary for DMH providers but service providers are encouraged to use them to reduce the risk of harm to service users.A pilot study to validate the Standards was undertaken in 2021,involving DMH service providers implementing

121、 the standards and an independent external assessment to test the assessment and accreditation framework.Evidence-based approach to the design of the NSQDMH The NSQDMH Standards were informed by experts and service users and modelled on the National Safety and Quality Health Service(NSQHS)Standards.

122、Technical requirements were included in the Standards in acknowledgement of the digital environment in which they will operate.The Therapeutic Goods Administration(TGA)was engaged in the development of the Standards.The TGA regulates software as a medical device(SaMD)and has developed an exemption p

123、rocess for DMH tools that are evidenced by established clinical guidelines.39 DMH tools falling outside TGA regulation may be appropriate for accreditation to the NSQDMH Standards.Lessons learned Standards should focus on addressing improvements in the safety and quality of systems.Privacy and prote

124、cting service users from harm are essential elements in the Standards.The ACSQHC determined that several technical actions in the NSQDMH Standards were challenging for a range of service providers to implement,regardless of their size and service delivery model.A comprehensive implementation strateg

125、y that includes specific resources and guidance for services may address many of these challenges.Service delivery for DMH should be research-and evidence-based and should have systems and processes in place to reduce the risk of harm,protect privacy and increase confidence and assurance in the safe

126、ty and quality of DMH tools.Accreditation The assessment of service providers to the NSQDMH Standards will commence in November 2022.Accrediting agencies approved by the ACSQHC will conduct assessments of the NSQDMH Standards.Providers that meet the requirements will be awarded accreditation.Service

127、 providers that receive accreditation will be authorized to display an accreditation badge.This accreditation badge will ensure consumers can identify DMH service providers that have met the expected standards for safety and quality.Governance Frameworks in Digital Mental Health15CASE STUDY 4New Zea

128、land Ministry of Health Mental health system overviewAccording to WHO-Five Well-Being Index(WHO-5)results at the end of 2020,1 in 4 adults in New Zealand had poor levels of mental well-being.40 New Zealand follows the same trends in mental health as other OECD countries.Individuals seeking mental he

129、alth support are referred by their general practitioner or family doctor to a psychologist or psychiatrist.During the pandemic(2020-2021),3.7%of the population accessed specialist mental health or addiction services.41 The Government boosted mental health funding in 2019 but,despite this investment,

130、the mental health systems reform has been difficult.In 2020,in collaboration with the World Economic Forum and Deloitte,the New Zealand Ministry of Health developed an initial Digital Mental Health&Addiction Services evaluation framework as part of its response to the He Ara Oranga report(a governme

131、nt inquiry into mental health and addiction)and the drive for mental health services presented by the COVID-19 pandemic.The initial standard was redesigned in collaboration with the eMHIC to develop the Digital Mental Health&Addiction Tool(DMHAT),which was released in 2021.Current state New Zealands

132、 Digital Mental Health Strategy was guided by This Way Up(implemented at St Vincents Hospital,Sydney,Australia).A hybrid model of care that included face-to-face as well as virtual/telehealth was considered vital.New Zealand is promoting the use of digital tools as complementary to mental health sup

133、port.The Government is integrating primary/acute care services with digital mental health tools and strengthening community-based support.Tihei Mauri Ora a Mori phrase expressing the“vital breath of life”guided the Ministry of Healths thinking throughout the process of developing the standards for e

134、-mental health.Key strengths and challenges of the mental health system The Government is strongly committed to providing health services and establishing telehealth services,including phone-based services to meet a high volume of services for the population.Major system reconfiguration inside the M

135、inistry of Health limited private health service delivery,particularly in the areas of mental health and addiction.Digital mental health tools have been used widely within the Mori community(for those under the age of 65).The lack of funding for implementation has been a barrier.Development of the d

136、igital mental health framework Detailed standards were developed in collaboration with the World Economic Forum and Deloitte.The core components of the standards were piloted with a range of stakeholders,including developers,clinicians,people with lived experience,Indigenous peoples and consumers.Th

137、e ORCHA framework was leveraged.The initial standard was redesigned in collaboration with the eMHIC to develop the DMHAT,which was released in 2021.The DMHAT covers specific issues related to equity,data,privacy,security,clinical governance,user experience,acceptance and cultural safety.The assessme

138、nt is an actively managed,self-assessment process.Evidence-based approach to the design of the digital mental framework The framework design incorporates health equity,local needs,data sovereignty and data management.It is aligned to the ORCHA framework.It was developed with the Aotearoa New Zealand

139、 context(recognizing the Indigenous name of the country)and Tihei Mauri Ora concept in mind.It comprises two components:the first sets out baseline standards expected of e-mental health tools and the second is a self-assessment tool for the designers and developers of these e-mental health tools.42D

140、igital Mental Health&Addiction Tool The DMHAT covers mobile apps and online tools and was driven by guiding principles and goals intended to reflect the needs of all consumers in New Zealand.The initial draft assessment approach was to form 55 wide-ranging individual standards that reflected the nee

141、ds of consumers and clinicians for safe,trusted,ethical,sustainable and effective solutions.The initial standard was redesigned in collaboration with the eMHIC to develop a lightweight assessment across four levels with a risk-based hierarchy to determine the appropriate assessment requirements for

142、each digital tool.43 These standards were grouped into mandatory questions,for all services,which set out baseline standards expected of the e-mental health tools,and supplementary questions,which depended on the functional scope,data collected,therapeutic claims and service workforce.Governance Fra

143、meworks in Digital Mental Health16 Each standard individually contained an objective that had to be met,with evidence indicating whether a vendor had met the standard or with examples of not meeting it.The four levels were well-being,general health,condition management,and integration with health re

144、cords or medical devices.The second component caters to designers and developers of e-mental health tools concerned with the user experience,clinical safety and quality,data privacy and security,technical security and stability.44 Enhanced review criteria are also included specific to the Aotearoa N

145、ew Zealand context,related to advertising,social responsibility and equity,cultural safety,user experience responsiveness and data sovereignty.45 Lessons learned The DMHAT can be leveraged by similar-sized jurisdictions.It is important to secure sufficient funding from the development of the toolkit

146、 to implementation and the establishment of an accreditation process for the entire process.It is best not to develop a toolkit during a pandemic as that creates its own set of obstacles.Diverse stakeholders should be consulted,including engaging local Indigenous communities and lived experience con

147、sumers,from the beginning of the process.Accreditation These standards provide the potential for a more formal accreditation pathway.The DMHAT was released in November 2021 as a beta version and the toolkit is open to refinement.Accreditation:The way forwardThis analysis shows that Australia is curr

148、ently leading the way by establishing a national accreditation process.In November 2022,Australia will form an independent accrediting agency approved by the Australian Commission on Safety and Quality in Health Care.The accreditation process will be voluntary.The intention is to provide much-needed

149、 guidance to consumers,clinicians and funders to better support their selection of safe and efficacious digital mental health tools.It is a powerful signal to the market.It provides“guard rails”creating a shared understanding of what“good”looks like.It will encourage both established service provide

150、rs and new innovators to comply.Moreover,it will enable clinicians to confidently recommend and prescribe tools to their patients,and will encourage public and private funders to reimburse their use.Germany has adopted a slightly different model but with the same outcomes in mind.With the DiGA or di

151、gital health applications that are available on prescription,46 the country has implemented an accelerated evaluation and reimbursement approach for digital health apps from the European Union.It has recently approved 11 mental health apps47 that are prescribed and can be reimbursed through its stat

152、utory health system.48Although much progress has already been made,this is only the beginning of a journey that is evolving.Real progress comes with substantial increases in access to high-quality and affordable mental health services.This future will allow consumers to choose how and when they acce

153、ss services and to select models of care that offer in-person,augmented and fully digital services that meet their preferences and requirements.The need for an ethical and regulatory framework to guide this journey ahead has never been more compelling.Governance Frameworks in Digital Mental Health17

154、UpLink innovators in youth mental healthMost mental ill health occurs during youth(between 15 and 24 years of age).3Governance Frameworks in Digital Mental Health18Standards for digital mental healthFIGURE 21.Lead practice with evidence9.Orient around person-centred design10.Promote social and cultu

155、ral respect11.Commit to equity and justice12.Advertise responsibly and accurately13.Enact a responsible business model14.Operate with accountability and accept feedback and complaints15.Provide a sustainable platform and continuity of care2.Do no harm3.Establish a risk management culture4.Ensure cli

156、nical safety and quality5.Commit to a robust service workforce 6.Promote data privacy and transparency7.Maintain data and information security8.Ensure the interoperability of healthcare records16.Govern artificial intelligence/machine learning responsiblyNote:Adapted from the“Global Governance Toolk

157、it for Digital Mental Health”to audit and govern digital mental health services and provide assurance of their safety,quality and efficacy.Source:DeloitteMental ill health,especially during youth,drastically impacts the early stages of social and emotional development,health education and employment

158、.It also coincides with a period of heavy technology use and access,potentially providing the opportunity to empower young people to address their mental health needs.Just as the regulation of digital mental health is rapidly evolving,so too is innovation.Much of it has been driven worldwide by youn

159、g people eager to improve their lives and their communities.To spotlight some of the many excellent solutions being built,the project team collaborated with UpLink,an open platform for innovation,launched by the World Economic Forum in 2020,centred on specific challenges supporting the UN Sustainabl

160、e Development Goals that seeks to source innovative solutions and connect them to resources to expand.49The aim of the Forums Youth Mental Health Challenge was to find start-ups led by young people that provide innovative evidence-based solutions to reduce the stigmatization of mental health and imp

161、rove well-being.50The UpLink platform provides a bridge for start-ups to work with entrepreneurs,investors,corporate partners,experts and organizations to help them develop.A total of 119 submissions were received from around the globe,75 of which met the criteria for evidence-based solutions in men

162、tal health.The top 14 innovators were selected.The assessment criteria leveraged insights from the 16 standards(Figure 2)for digital mental health outlined in the“Global Governance Toolkit for Digital Mental Health”.Using the criteria listed in Table 1,14 of the top submissions(Figure 3)were selecte

163、d and invited to join the UpLink Innovation Network Programme.This programme is facilitated by the Forum and its partners to help increase and advance sustainability and impact.World Economic Forum UpLink Youth Mental Health ChallengeGovernance Frameworks in Digital Mental Health19Assessment criteri

164、a for submissions for the UpLink Youth Mental Health Challenge51TABLE 1Financially viable business modeSolutions need to demonstrate a sustainable business model and approach to revenue and represent investable opportunities for investors or philanthropic funders.Effective impactSolutions need to sh

165、ow a positive impact on youth mental health and well-being.EthicalSolutions need to be aligned with youths interests and demands,ensuring tools and/or services are ethical and transparent in terms of their purpose,models of care,use of data and technology,and integration into health systems.Equitabl

166、e and inclusiveSolutions need to contribute to reducing an identified gap,such as geography,economics,gender,age,disability,affordability,technical skills and digital literacy.Solutions will be accessible,appropriate and free from discrimination,for those who will need them most.SafeSolutions need t

167、o be safe to use for the intended purpose and incorporate processes to do no harm.Solutions will show a commitment toresponsibly stewarding the datacollected,stored and prepared,shared,analysed and used.SustainableSolutions should support the mental health infrastructure long term,strengthening it t

168、hrough capacity building,supporting re-/upskilling and task shifting/task sharing innovations.Socio-ecologicalSolutions that encompass a joint,rather than individualistic,approach are encouraged;this can mean involving communities,family units,neighbourhoods or peers to support positive mental healt

169、h and well-being.Measurement and standards verificationSolutions should demonstrate a clear impact monitoring and evaluation framework.The metrics and indicators should be tracked transparently;relevant robust standards are referenced and applied;and independent credentialing and third-party verific

170、ation received.Governance,team and operating modelsSolutions should have a legal entity attached to the project or technology and a diverse leadership team with the right capacity and skill set to deliver on the projects mission.The operating model should show the extent to which the project has ach

171、ieved financial viability and sustainable revenue streams or has a vision and plan for achieving it.Note:Youth-led submissions were strongly considered,provided they met the criteria for assessment.Source:UpLinkGovernance Frameworks in Digital Mental Health2014 top innovators representing innovative

172、 solutions in youth mental health,also aligned with the standards for digital mental healthFIGURE 3BrazilCanadaUSAAustraliaZambiaUK,France,Germany,NetherlandsNorwayLebanonIndiaUkraineSomaliaKenyaIndonesiaChinaSouth AfricaNambia&UgandaZimbabwe/Angola,Eswatini,Ghana,Mozambique,Namibia,Nigeria,Rwanda,T

173、anzania,Uganda,Zambia,Zimbabwe ThailandZimbabweIrelandMalaysiaUKSource:DeloitteGovernance Frameworks in Digital Mental Health21ConclusionThe goal of a governance framework for digital mental ill health is to incentivize the growth of safe,ethical,trusted and strategic innovation in mental health wit

174、hout stifling innovation.The Fourth Industrial Revolution is defined by an ever-increasing rate of innovation across and between technological domains.With every passing year,technology becomes more powerful,yet the governance structures and regulatory mechanisms underpinning them have changed littl

175、e.There are no easy answers or quick fixes,and the problem is doubly challenging when disruptive technologies intersect with a topic that is as deeply personal as mental ill health.This is truly an unprecedented moment in human history,yet it is also a moment of great uncertainty:if the urge to“move

176、 fast and break things”is not coupled with a deep consideration of the consequences,mankind runs the risk of missing an opportunity to truly improve the well-being of people everywhere.The regulation of digital mental health tools is fragmented.These tools operate in several jurisdictions and a larg

177、e variety of settings,such as schools and workplaces,or direct-to-consumer,etc.,as well as in the more traditional medical arenas.Each setting has its own standards,policies and frameworks.This makes the need for an overarching digital mental health accreditation process and regulatory framework cri

178、tical.Data sharing,privacy and cybersecurity concerns still envelop the plethora of digital mental health tools in the market.These tools are collecting sensitive information on consumer-reported data to do with mood,journaling,medication adherence and guided psychological interventions,providing me

179、ntal health stories and histories and evaluating symptoms.Yet the lines of informed consent for mental health information remain blurred.A review of commonly used health apps available for iOS and Android devices indicated that only 30.5%had privacy policies and two-thirds of these policies were not

180、 specific to the app itself.52 Technological capabilities,such as zero-knowledge encryption,that ensure data is kept secure and that the app developer does not have access to the data,are one potential solution.As the case studies in this paper have shown,emerging standards and frameworks provide mu

181、ch-needed guidance for service developers and providers to incorporate privacy policies,data transparency and health information security in digital mental health tools.A stringent accreditation process that identifies and endorses the tools that meet these defined standards builds confidence and re

182、assures all the stakeholders in the ecosystem.This is especially important when considering the urgent need to continue to develop the sector as well as the role of investors and employers in delivering this ambition.The investment in mental health services53,54,55and digital mental health services5

183、6,57 in recent years has been unprecedented.Also evident is employers increasing the scope of services offered to their employees.For example,the Deloitte Mental Health and Well-Being in the Workplace 2022 survey found significant investment in raising awareness,extending the employee benefits progr

184、amme,and initiating training programmes for leadership with a focus on how to identify and support staff experiencing mental distress.58 Sustaining this much-needed growth in service provision would not be possible in the absence of an ethical regulatory framework.But this work is certainly not yet

185、finished.To grapple with this new reality and build radically new models of governance,it is necessary to first recognize that this is a rapidly changing landscape.What is considered“best practice”today will continually need to be refreshed or will quickly become obsolete.When this work began four y

186、ears ago,the idea that a global pandemic could upend the world and supercharge the need for disruptive technology for mental health was unthinkable.The concept of the“metaverse”had not entered the cultural lexicon.Interest in applications of blockchain and cryptocurrencies for mental health were nas

187、cent but had not yet been matched with the investments now seen.This is the beginning of the journey.The regulatory structures of the future must be as dynamic and flexible as the advances they govern.Governance Frameworks in Digital Mental Health22ContributorsLead authorsStephanie Allen Leader,Glob

188、al and Australia Healthcare Sector,Deloitte,AustraliaAminath Azhan Fellow,Disruptive Technologies in Mental Health,World Economic Forum;Senior Consultant,Deloitte,AustraliaCameron Fox Lead,Health and Healthcare,World Economic Forum LLC Clare Medhurst Fellow,Disruptive Technologies in Mental Health,W

189、orld Economic Forum;Specialist Director,Deloitte,Australia AcknowledgementsMaureen Abbott Manager,Access to Quality Mental Health Services,Mental Health Commission,CanadaMargaret Banks Director,Australian Commission on Safety and Quality in Health Care,AustraliaChristopher Boyd-Skinner Program Manag

190、er,Digital Mental Health,Australian Commission on Safety and Quality in Health Care,AustraliaJennifer Caspari Senior Manager,Deloitte,USAArran Culver Acting Deputy Director-General,Mental Health and Addictions,Ministry of Health,New ZealandPhilip Grady Acting Deputy Director-General,Mental Health an

191、d Addictions,Ministry of Health,New ZealandChristina McCarthy Executive Director,One Mind at Work,USADavid Rabinowitz Senior Manager,Monitor Deloitte,USASandra Rigby Project Officer,Digital Mental Health,Australian Commission on Safety and Quality in Health Care,AustraliaVictor Storm Senior Clinical

192、 Adviser,Digital Mental Health,Australian Commission on Safety and Quality in Health Care,AustraliaSapna Wadhawan Program Manager,Access to Quality Mental Health Services,Mental Health Commission,CanadaSylvia Yan Associate Director,Deloitte,New ZealandWorld Economic ForumShyam Bishen Head,Platform f

193、or Shaping the Future of Health and HealthcareAnna Huber Impact Lead,Water and DevelopmentBonnie Rowe Fellow,Disruptive Technologies in Mental Health;Director,Deloitte,AustraliaGovernance Frameworks in Digital Mental Health231.Doraiswamy,P.Murali,et al.,“Empowering 8 Billion Minds:Enabling Better Me

194、ntal Health for All via the Ethical Adoption of Technologies”,National Academy of Medicine,Discussion Paper,28October 2019,https:/nam.edu/empowering-8-billion-minds-enabling-better-mental-health-for-all-via-the-ethical-adoption-of-technologies(accessed 24October 2022).2.Firth,Joseph,et al.,“The Lanc

195、et Psychiatry Commission:a blueprint for protecting physical health in people with mental illness”,The Lancet Psychiatry,vol.6,no.8,2019,pp.675-712.3.Walker,Elizabeth Reisinger,et al.,“Mortality in mental disorders and global disease burden implications:a systematic review and meta-analysis”,JAMA Ps

196、ychiatry,vol.72,no.4,2015,pp.334-41.4.World Health Organization(WHO),Preventing suicide:A global imperative,2014,https:/www.who.int/publications/i/item/9789241564779(accessed 25October 2022).5.Kessler,Ronald C.,et al.,“Age of onset of mental disorders:A review of recent literature”,Current Opinion i

197、n Psychiatry,vol.20,no.4,2007,pp.359-64.6.Santomauro,Damian F.,et al.,“Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic”,The Lancet,vol.398,no.10312,2021,pp.1700-12.7.Lancet Commission,“Report:Mental illness will c

198、ost the world$16 trillion(USD)by 2030”,Mental Health Weekly,vol.28,no.39,15October 2018,pp.7-8.8.World Health Organization(WHO),Global Health Observatory,“Psychiatrists working in mental health sector(per 100,000)”,2019.9.US National Institute of Mental Health,“Mental Health Information:Mental Illne

199、ss”,January 2022 update,https:/www.nimh.nih.gov/health/statistics/mental-illness(accessed 25October 2022).10.The White House,“FACT SHEET:Biden-Harris Administration Announces Two New Actions to Address Youth Mental Health Crisis”,Briefing Room Statements and Releases,29July 2022,https:/www.whitehous

200、e.gov/briefing-room/statements-releases/2022/07/29/fact-sheet-biden-harris-administration-announces-two-new-actions-to-address-youth-mental-health-crisis(accessed 26 October 2022)11.Centre for Addiction and Mental Health(CAMH),“Mental Illness and Addiction:Facts and Statistics”,https:/www.camh.ca/en

201、/driving-change/the-crisis-is-real/mental-health-statistics#:text=Prevalence,Canadians%20experiences%20a%20mental%20illness.&text=By%20the%20time%20Canadians%20reach,have%20had%20%E2%80%93%20a%20mental%20illness(accessed 26October 2022).12.Ibid.13.Mood Disorders Society of Canada,“2022 Mental Health

202、 Care System Survey Report Results”,2022,https:/mdsc.ca/research/2022-mental-health-care-system-study-report(accessed 24October 2022).14.Mental Health Commission of Canada,E-Mental Health Implementation E-Modules,https:/mentalhealthcommission.ca/e-mental-health-implementation-e-modules(accessed 21Oc

203、tober 2022).15.Mental Health Commission of Canada,“Toolkit for e-Mental Health Implementation”,https:/mentalhealthcommission.ca/resource/toolkit-for-e-mental-health-implementation(accessed 21October 2022).16.Ibid.17.Mental Health Commission of Canada,E-Mental Health Implementation E-Modules,op.cit.1

204、8.Mental Health Commission of Canada,E-Mental Health,https:/mentalhealthcommission.ca/what-we-do/e-mental-health(accessed 21October 2022).19.Government of Canada,“Government of Canada connects Canadians with mental wellness supports during COVID-19”,News release,15April 2020,https:/www.canada.ca/en/

205、health-canada/news/2020/04/government-of-canada-connects-canadians-with-mental-wellness-supports-during-covid-190.html(accessed 21October 2022).20.Mental Health Commission of Canada,“Stepped Care 2.0:What makes it different?”,16November 2021,https:/mentalhealthcommission.ca/resource/what-is-stepped-

206、care-2-0-4-pager(accessed 20October 2022).21.Wellness Together Canada website,https:/www.wellnesstogether.ca/en-CA(accessed 20October 2022).22.eMental Health International Collaborative(eMHIC),“Ethics and Law as Essential to e-Mental Health”Position Statement,https:/ 20October 2022).23.BikeHike,“Wha

207、t Are The Aims Of Health Care Reform In Canada”,https:/bikehike.org/what-are-the-aims-of-health-care-reform-in-canada(accessed 21October 2022).24.Australian Government,Australian Institute of Health and Welfare,“Overview of mental health services in Australia”,2022,https:/www.aihw.gov.au/getmedia/40

208、14cc4d-7d20-4da8-8640-8c1c2b3f958d/Overview-of-mental-health.pdf.aspx(accessed 21October 2022).25.Australian Government,Australian Institute of Health and Welfare,“Mental health:prevalence and impact”,7July 2022 update,https:/www.aihw.gov.au/reports/mental-health-services/mental-health(accessed 21Oc

209、tober 2022).26.Australian Government,Australian Institute of Health and Welfare,“Overview of mental health services in Australia”,op.cit.27.Ibid.EndnotesGovernance Frameworks in Digital Mental Health2428.Usher,Kim,et al.,“The 20192020 bushfires and COVID-19:The ongoing impact on the mental health of

210、 people living in rural and farming communities”,International Journal of Mental Health Nursing,vol.30,no.1,2021,pp.3-5.29.Berger,Emily,and Andrea Reupert,“The COVID-19 pandemic in Australia:Lessons learnt”,Psychological Trauma:Theory,Research,Practice,and Policy,vol.12,no.5,2020,pp.494-496.30.Botha

211、,Ferdi,Peter Butterworth and Roger Wilkins,“Evaluating How Mental Health Changed in Australia through the COVID-19 Pandemic:Findings from the Taking the Pulse of the Nation(TTPN)Survey”,International Journal of Environmental Research and Public Health,vol.19,no.1,2022,p.558.31.Australian Government,

212、National Mental Health Commission,“Vision 2030:Blueprint for Mental Health and Suicide Prevention”,https:/www.mentalhealthcommission.gov.au/projects/vision-2030#:text=Vision%202030%20has%20been%20delivered,individuals%20needs%20and%20prevent%20escalating(accessed 21October 2022).32.Hospital and Heal

213、thcare,“New standards for safe and effective digital mental health care”,30November 2020,https:/.au/content/aged-allied-health/article/new-standards-for-safe-and-effective-digital-mental-health-care-198591186(accessed 21October 2022).33.Australian Commission on Safety and Quality in Health Care,“Abo

214、ut us”,https:/www.safetyandquality.gov.au/about-us(accessed 21October 2022).34.Parliament of Australia,“National Mental Health Commission Report for 2019-20”,2020,https:/parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22publications%2Ftabledpapers%2Ffdb36eaf-7449-41fb-80ce-72eb79

215、19cac8%22(accessed 21October 2022).35.Commonwealth of Australia,Department of Health and Aged Care,“Record investment in the future of Australias health system”,Media release,29March 2022,https:/www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/record-investment-in-the-future-of-australias-heal

216、th-system(accessed 21October 2022).36.Australian Government,Australian Institute of Health and Welfare,“Mental health:prevalence and impact”,op.cit.37.Australian Government,National Mental Health Commission,“Vision 2030:Blueprint for Mental Health and Suicide Prevention”,March 2020,https:/www.mental

217、healthcommission.gov.au/getmedia/28fe94a6-ae18-47d3-bd62-ad8a048b8582/NMHC_Vision2030_ConsultationReport_March2020.pdf(accessed 26October 2022).38.Australian Government,National Mental Health Commission,“National Mental Health Commission Submission to the Select Committee on Mental Health and Suicid

218、e Prevention”,p.22,https:/www.mentalhealthcommission.gov.au/getmedia/924c7953-9f77-4064-a6d4-64e5cb2c9c8d/Submission-to-the-Select-Committee-on-Mental-Health-and-Suicide-Prevention-14032021(accessed 21October 2022).39.Australian Government,Department of Health,Therapeutic Goods Administration,“Digit

219、al mental health:Software based medical devices”,April 2022,https:/www.tga.gov.au/sites/default/files/digital-mental-health-software-based-medical-devices.pdf(accessed 24October 2022).40.Mental Health Foundation of New Zealand and Ipsos,“Wellbeing Amongst New Zealanders”,12January 2021,https:/mental

220、health.org.nz/resources/resource/wellbeing-amongst-new-zealanders(accessed 24October 2022).41.New Zealand Government,Mental Health and Wellbeing Commission,Te Huringa:Change and Transformation:Mental Health Service and Addiction Service Monitoring Report 2022,2022,https:/www.mhwc.govt.nz/assets/Te-H

221、uringa/Finals-1-April-2022/MHWC-Te-Huringa-Service-Monitoring-Report.pdf(accessed 26October 2022).42.New Zealand Government,Ministry of Health-Manat Hauora,“Assessment framework for safe e-mental health tools”,16November 2021 update,https:/www.health.govt.nz/our-work/digital-health/other-digital-hea

222、lth-initiatives/assessment-framework-safe-e-mental-health-tools(accessed 21October 2022).43.New Zealand Government,Ministry of Health-Manat Hauora,“Digital Mental Health and Addiction Tool(DMHAT),Introductory Guide”,Beta version 1.0,November 2021.44.New Zealand Government,Ministry of Health-Manat Ha

223、uora,“Assessment framework for safe e-mental health tools”,op.cit.45.New Zealand Government,Ministry of Health-Manat Hauora,“Digital Mental Health and Addiction Tool(DMHAT),Introductory Guide”,op.cit.46.Federal Ministry of Health of Germany,gesund.bund.de,“Digital health applications(DiGA):apps on p

224、rescription”,29September 2021,https:/gesund.bund.de/en/digital-health-applications-diga(accessed 25October 2022).47.Engberg,Anna,“Germany approves new digital mental health app for prescription”,MobiHealthNews,5March 2021,https:/ 25October 2022).48.Federal Institute of Drugs and Medical Devices of G

225、ermany,“DiGA Digital Health Applications”,2022,https:/www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html(accessed 25October 2022).49.UpLink,the open innovation platform of the World Economic Forum,is funded by Salesforce and supported by a variety of partners,

226、including Deloitte,UNICEF,citiesRISE,Z Zurich Foundation,7Cups,Healthy Brains Global Initiative,Karolinska Institute,Fondation Botnar,the MHPSS Collaborative,United for Global Mental Health,the Bertha Centre for Social Innovation and Entrepreneurship and Harvard University.50.UpLink,“Youth Mental He

227、alth Challenge”,https:/uplink.weforum.org/uplink/s/uplink-issue/a002o0000136WJnAAM/youth-mental-health-challenge(accessed 21October 2022).51.UpLink,“Youth Mental Health Challenge,About”,https:/uplink.weforum.org/uplink/s/uplink-issue/a002o0000136WJnAAM/youth-mental-health-challenge?activeTab=Challen

228、ge-About(accessed 20October 2022).Governance Frameworks in Digital Mental Health2552.Sunyaev,Ali,et al.,“Availability and quality of mobile health app privacy policies”,Journal of the American Medical Informatics Association,vol.22,no.e1,2015,pp.e28-e33.53.Mental Health Australia,“2022 Federal Budge

229、t Summary”,1April 2022,https:/mhaustralia.org/general/2022-federal-budget-summary(accessed 25October 2022).54.The White House,“FACT SHEET:Biden-Harris Administration Announces Two New Actions to Address Youth Mental Health Crisis”,op.cit.55.Shah,Ravi N.,and Obianuju O.Berry,“The Rise of Venture Capi

230、tal Investing in Mental Health”,JAMA Psychiatry,vol.78,no.4,2021,pp.35152.56.Government of the United Kingdom,“Mental health funding of 1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools”,Press release,10October 2022,https:/www.gov.uk/government/news/mental-health-fu

231、nding-of-18m-welcomed-by-mhra-and-nice-to-explore-regulation-of-digital-mental-health-tools(accessed 15October 2022).57.Auxier,Brooke,Ariane Bucaille and Kevin Westcott,“Mental health goes mobile:The mental health app market will keep on growing”,Deloitte,1December 2021,https:/ 25October 2022).58.Su

232、rvey conducted as part of the Deloitte Health Equity Institute initiative,“Mental health and well-being in the workplace”,September 2022,https:/ 21October 2022).Governance Frameworks in Digital Mental Health26World Economic Forum9193 route de la CapiteCH-1223 Cologny/GenevaSwitzerland Tel.:+41(0)22

233、869 1212Fax:+41(0)22 786 2744contactweforum.orgwww.weforum.orgThe World Economic Forum,committed to improving the state of the world,is the International Organization for Public-Private Cooperation.The Forum engages the foremost political,business and other leaders of society to shape global,regional and industry agendas.