WHO Global Strategy on Digital Health

WHO publishes its global digital health strategy

The World Health Organisation (WHO) has published its Global Strategy on Digital Health 2020–2025 as it looks to “improve health for everyone, everywhere by accelerating the development and adoption of appropriate, accessible, affordable, scalable and sustainable person centric digital health solutions”.

The publication of the strategy marks an end to a long process that began with the 2005 resolution on eHealth that urged WHO member states “to consider drawing up a long-term strategic plan for developing and implementing eHealth services… to develop the infrastructure for information and communication technologies for health… to promote equitable, affordable and universal access to their benefits”. In the meantime, further resolutions had been passed at WHO level and passed by the United Nations and World Health Assembly. A draft digital health strategy covering 2020-2024 was initially published in the summer of 2020, but the strategy proper has now been published.

The strategy states that digital health will be adopted if it “is accessible and supports equitable and universal access to quality health services; enhances the efficiency and sustainability of health systems in delivering quality, affordable and equitable care; and strengthens and scales up health promotion, disease prevention, diagnosis, management, rehabilitation and palliative care including before, during and after an epidemic or pandemic, in a system that respects the privacy and security of patient health information”. It is recommended within that adoption of digital health technologies be a component of any national strategy, although it is acknowledged that this will be a challenge, especially in low- and middle-income countries. Member states are advised that exploring the potential of global solutions should be a part of their national strategies.

The purpose of the strategy is “to strengthen health systems through the application of digital health technologies for consumers, health professionals, health care providers and industry towards empowering patients and achieving the vision of health for all” and it emphasises that “health data are to be classified as sensitive personal data, or personally identifiable information, that require a high safety and security standard”.

The strategy is guided by four principles:

1. “Acknowledge that institutionalisation of digital health in the national health system requires a decision and commitment by countries”: Each country owns its digital health action plan built on the strategy within its own national context and should adopt digital health in a way that is “sustainable, respects their sovereignty, and best suits their culture and values, national health policy, vision, goals, health and wellbeing needs, and available resources”.

2. “Recognise that successful digital health initiatives require an integrated strategy”:

Member states should be aware that for digital health initiatives to reach their potential, they should be “part of the wider health needs and the digital health ecosystem and guided by a robust strategy that integrates leadership, financial, organizational, human and technological resources and is used as the basis for a costed action plan which enables coordination among multiple stakeholders”.

3. “Promote the appropriate use of digital technologies for health”: The strategy

“underscores the need to ground digital foundations within national strategies and emphasises the need to work with different sectors and stakeholders at all levels” and states that the “appropriate use of digital health takes the following dimensions into consideration: health promotion and disease prevention, patient safety, ethics, interoperability, intellectual property, data security (confidentiality, integrity, and availability), privacy, cost-effectiveness, patient engagement, and affordability”.

4. “Recognise the urgent need to address the major impediments faced by leastdeveloped countries implementing digital health technologies”: There is a

“pressing need” to engage with and invest in the issues developing nations face in engaging with digital health, such as “an appropriate enabling environment, sufficient resources, infrastructure to support the digital transformation, education, human capacity, financial investment and internet connectivity”.

These four principles then inform the four strategic objectives of the strategy:

1. Promote global collaboration and advance the transfer of knowledge on digital health: Member states are instructed to share their knowledge of and investments in digital health across domains in order to align countries strategically. The policy initiatives recommended to achieve this goal include the establishment of mechanisms for strengthening national digital health strategies and implementing key collaborations, the establishment of a knowledge management approach to identify and share good practices and the supporting of countries in establishing information centres for disease surveillance.

2. Advance the implementation of national digital health strategies: Under this objective, the WHO aims to “stimulate and support every country to adopt or review, own, and strengthen its national digital health strategy” through defining a national digital health architecture blueprint or roadmap and adopting opensource health data standards, while aiming for reusable systems or assets including interoperability of health information systems both at national and international levels.

3. Strengthen governance for digital health at global, regional and national levels:

The WHO is seeking to strengthen the governance of digital health at local and international levels “through the creation of sustainable and robust governance structures”, including regulatory frameworks. Under this goal, the WHO calls on its member states to “coordinate investments in evidence-based approaches to assess promote and disseminate new and innovative health technologies for national scaled digital health programmes using a person-centred approach to facilitate actions and investments based on informed decisions”.

4. Advocate people-centred health systems that are enabled by digital health: This objective “advances digital health literacy, gender equality and women’s empowerment and inclusive approaches to adoption and management of digital health technologies” and “places people at the centre of digital health through the adoption and use of digital health technologies in scaling up and strengthening health service delivery”. This is to be achieved by developing approaches to the management of health at the population level through digital health applications that move health and well-being from reactive-care models to active communitybased models, reducing the burden of data collection from front-line workers by reorienting reporting-based tools into service delivery tools and establishing, monitoring and evaluating models to facilitate the contribution of digital systems to health system processes.

The WHO says it will take steps to implement a measurement model to evaluate the action plan and the stated set of outputs in collaboration with national centres, the Sustainable Development Goals and the goals of WHO’s Thirteenth General Programme of Work, 2019–2023. They state that the establishment of a monitoring and evaluation framework that promotes a biennial enhancement of the global digital health strategy is “also warranted”.

Medical devices regulation

Credit: Tom Claes

In May 2021, a year later than scheduled, stronger rules on medical devices were introduced across the EU.

The Medical Devices Regulation (MDR) was politically agreed across the EU’s Parliament, Commission and Council in May 2017 and was set to become fully applicable in May 2020 following a three-year transition period. The outbreak of Covid-19, however, saw a 12-month delay imposed on the application as device manufacturers turned their attention to addressing the challenges posed by the pandemic.

The MDR became fully applicable on 26 May, 2021 and represents a strengthening of the existing regulatory system for medical devices across Europe and a replacement of the original directives which had been in place for some 25 years. As a regulation, rather than a directive, the MDR is directly applicable at national level, without the requirement for transposition through national legislation, enabling greater legal certainty and preventing variation in the rules relating to medical devices across member states.

The regulation covers over 500,000 types of medical devices on the EU market, ranging from hip replacements to sticking plasters. Medical devices are defined as those that have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

It does not overwrite the fundamental components of the current regulatory systems but aims to strengthen them through addressing identified gaps or weaknesses and gives consideration to technological and regulatory developments in the medical technology sector. and create fair market access for manufacturers.

Speaking as the regulation came into force, Stella Kyriakides, European Commissioner for Health and Food Safety, said: “This is an important step forward for the protection of patients across Europe. The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for businesses. The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges.”

Separately from the MDR, a regulatory framework applicable to in vitro diagnostic (IVD) medical devices is set to come into force on 26 May 2022. In vitro diagnostic medical devices are used to perform tests on samples, include HIV blood tests, pregnancy tests, Covid-19 tests and blood sugar monitoring systems for diabetics.

The three main aspects of the MDR, for which the National Standards Authority of Ireland is the sole notified body (subject to supervision by the Health Products Regulatory Authority) in Ireland, are:

Quality, safety, reliability and improvement: Tighter controls are imposed on high-risk devices, such as implants, and consultation of a pool of EU level experts is required before devices are placed on the market. Additionally, clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls;

Strengthens transparency and information: Vital information for patients will be easier to find with the European database of medical devices (EUDAMED) containing information about each medical device on the market, including economic operators and certificates issued by notified bodies. Additionally, each device will have a unique device identifier, to make sure it is findable on the database; and

Enhance vigilance and market surveillance: Manufacturers will be required to collect data about the devices’ performance once it is on the market and member states will improve coordination on vigilance and market surveillance.

Three pillars of digital transformation

Public service is more proactive in digital transformation than people think and typically uses three key pillars for change writes Peter Rose, CIO of TEKenable.

The advent of Covid accelerated the need for digital transformation across the public and private sectors where there was already a fast pace of change. We have worked with the HSE delivering contact tracing and the PPE ordering system (amongst others) but even before Covid, TEKenable worked with Dublin City Council to deliver Voter.ie, providing online registration to vote, with An Post to deliver Ad Mailer, a digital transformation of postal advertising campaigns and Mayo County Council to streamline recruitment, all based on the three pillars below.

Pillar One: Self-service

If you are still requiring paper forms, you are accepting the responsibility and cost of correcting the inevitable errors and omissions. Providing online selfservice capabilities to your patients/staff is a “no-brainer”. It ensures data quality at point of entry eliminating the chase processes that are required to deal with errors on paper forms and enables the end user to engage at their convenience. We refer to this approach to data quality as: “Clean the river, not the lake.”

Pillar Two: Customer engagement

CRM is a bit old hat now; customer engagement is the new gun in town. Create an omni-channel communications hub including bots and personalisation, centralising customer data, integrate it with a workflow layer that spans siloed IT systems and crosses departmental boundaries, and you will deliver an optimum experience. Customer-facing staff will have full visibility of the customer and managers a full view of the processes and any bottle necks.

Pillar Three: Back-office process automation

The Self-Service pillar removes some non-value adding processes from the back office, but it is not the full story. Building on the customer engagement layer, back-office processes can now also span the artificial boundaries created by legacy IT systems and departmental structures. This delivers cost savings and improved patient experience through efficiency. By adding artificial intelligence and robotic process automation we can also remove the mundane work and reduce error rates leaving your staff free to deliver the real value-added services, those that need a human touch. Our experience has been that staff who are impacted by this type of change experience an increase in job satisfaction, patient satisfaction increases, and complaints go down.

Low code platforms enable digital transformation

With major change programmes commencing in many government departments, local authorities, and the public sector in general there is a key differentiator between success and failure, the IT tools used to deliver that change.

We use low code platforms such as Microsoft’s Power Platform in conjunction with the power of the Azure cloud to tackle in-depth and complex challenges, making application development much more efficient, flexible, and responsive to change.

Dynamics 365 and Power Platform from TEKenable can deliver Self-Service with Customer Engagement, can support back-office Process Automation and apply Advanced AI and RPA to improve efficiency with much of this not needing to be built, it is out of the box.

Talk to us if you are interested in seeing what can be done when you have the right tools!

Peter Rose TEKenable Ltd – Harmony Court, Harmony Row, Dublin 2 peter.rose@tekenable.com +353 87 271 2660 www.tekenable.ie

Virtual health: The next frontier

As automation comes to the fore of daily life and the Covid-19 pandemic leaves healthcare providers looking for alternative methods to deliver treatment, boost quality of care and decrease spending, virtual health strategies may begin to become a more common mode of healthcare delivery.

Virtual health has long been heralded as the next breakthrough in health technology, but its adoption has varied between slow to non-existent from country to country. Virtual health can be broadly broken down into three categories: telehealth, digital therapeutics, and care navigation.

These categories further break down into subcategories such as synchronous and asynchronous telehealth, remote patient monitoring, replacement therapies, treatment optimisation, patient self-directed care and e-triage. Commonwealth Fund research showed that adult primary care and behavioural health showed smaller declines in total visits during the pandemic than surgical/procedural specialties. These smaller declines illustrate the fact that primary care and behavioural health visits can be accomplished by evaluation and management only as opposed to surgical specialities. Such differences in specialities suggest that opportunities are there for the further rollout of virtual health technologies, such as remote monitoring, which could allow both primary care and specialty care practices to expand their virtual patient interactions.

A pre-pandemic survey of health system leaders performed by McKinsey and Company in 2019 revealed that “virtual health adoption was highly concentrated in synchronous telemedicine, with limited investment in the full suite of available virtual health technologies”. These health system leaders also cited remote monitoring as a key area for future investment. Prior to the pandemic, McKinsey “found that health systems, under value-based care arrangements, demonstrated 17 per cent savings when they provided virtual care with their existing healthcare professionals instead of using an outsourced provider”, showing the opportunity that exists for providers to embrace the technologies from both a modernising and a financial standpoint.

Particularly relevant to the Irish context could be the opportunities that exist to promote efficiency through models like tele-ICU and change-capacity use through “hospital at home” (HaH) models. Examples of models cited by McKinsey that could be of use in rural Ireland where access to speciality services is scare include:

• a regional health system that provides virtual specialist visits and tele-ICU coverage in partnership with local rural health systems to extend access to services;

• a regional health system that partners with a third-party provider of virtual primary care to extend its primary care capacity and creates linkages to its specialty practices;

• an academic medical centre (AMC) that provides virtual specialty care that consumers access directly from different geographies, with some consumers choosing to travel for care; and

• a regional health system that provides primary and specialty care through physical and virtual applications, and partners with an

AMC to access virtual sub-specialty care.

The HaH setting in particular could be of significant benefit in Ireland, where an ageing population can often be matched with rural isolation, meaning that the implementation of HaH could mean both a reduction in travel for many patients and a reduction in healthcare-associated infections. Covid-19 has prompted much talk of a “new normal”; in healthcare, it appears the time is ripe for the new normal to incorporate the disruption that has been talked about long before the outbreak of the pandemic.

Leveraging new technology to deliver responsive nursing and midwifery regulation

These are times of both change and challenge, for the health sector and for NMBI, and the way in which we respond will define our future, writes Sheila McClelland, the CEO of the Nursing and Midwifery Board of Ireland (NMBI).

At NMBI we are leveraging new technology to continue our important work as a regulator, in the face of a global pandemic, while also progressing our digitisation and modernisation agenda to adapt to the evolving needs of the health sector. As we hopefully emerge from the worst of the pandemic it is time to build on what we have done best during the height of the crisis, and we are now using new technologies and better ways of working to create a more agile and responsive regulator.

The role of NMBI

As the regulator for nurses and midwives in Ireland, our mission is to protect the public and the integrity of the professions of nursing and midwifery.

We focus on three areas specifically:

• Publication and maintenance of the

Register of Nurses and Midwives and the Candidate Register;

• Education standards and requirements; and

• Complaints about the practice or behaviour of a nurse or midwife.

Using technology to modernise

NMBI is on a journey to provide a more modern, responsive, and agile model of service provision and regulation. Technology is central to this journey, and I believe it is important to embrace it and use it to drive positive change and allow us to work better together in new ways.

Fitness to practise

As the regulator, NMBI is legally responsible for considering complaints against nurses and midwives who practise in Ireland, to ensure the protection of the public and the safeguarding of confidence in the nursing and midwifery professions. The pandemic brought a halt to the running of onsite/in-person inquiries. Our fitness to practise team responded quickly. Online inquiry solutions were identified, tested, and rolled out, after engaging with those involved. Since December 2020, 17 inquiries have concluded in online or in hybrid form, over 37 inquiry days.

This change, using new technology, was born out of necessity but has proved beneficial. Now that restrictions have eased, we are keeping the best of what we created to help improve the way we work. A hybrid approach is being taken to inquiries, with some participants physically present and others participating online.

Education

Our education team is using new technology to evolve the way they work and ensure they are more agile, carrying out virtual site inspections. These are proving successful, and more are planned.

Registration

New technology is also driving change in our registration process. In the past year we have broken new ground with the launch of our digital platform MyNMBI. We were the first healthcare regulator to digitise all of our registration processes, allowing registrants to avail of a range of services online and leading to the collection of better data. As with all new technology there was a bedding-in period and there were some user-experience issues at the outset of this new system, but our teams worked hard to address these and to ensure that we learned from them. I am confident that over time the benefit of digitisation will significantly outweigh the teething problems experienced.

NMBI is on a journey to becoming a more efficient and effective regulator and new technology is enabling us to better deliver on our mandate of upholding the high standards of nursing and midwifery in Ireland and ensuring public safety.

E: communications@nmbi.ie W: www.nmbi.ie