Standards Development

Scope

his standard specifies a series of quality measures used to establish high quality telehealth systems at a global level when an organization:

a) needs to demonstrate its ability to consistently provide services that meet customer/ patient, stakeholder, and applicable statutory and regulatory requirements,

b) aims to enhance customer/patient satisfaction through the effective application of the telehealth system, including processes for improvement of the system and the assurance of conformity to customer/patient, and applicable statutory and regulatory requirements, and

c) demonstrate its commitment to a telehealth system that is for the people, equitable, resilient, safe and efficient.

The requirements of this International Standard are intended to be applicable to any telehealth system, regardless of its organizational structure or size.

Purpose

• “Human health has only ever improved because of advances in technology. From the development of modern sanitation to the advent of penicillin, anaesthesia, vaccines and magnetic resonance imaging, science, research and technology have always been key drivers of better health. It’s no different today. Advances in technology are continuing to push back the boundaries of disease. Digital technologies enable us to test for diabetes, HIV and malaria on the spot, instead of sending samples off to a laboratory. 3-D printing is revolutionizing the manufacture of medical devices, orthotics and prosthetics. Telemedicine, remote care and mobile health are helping us transform health by delivering care in people’s homes and strengthening care in health facilities. Harnessing the power of digital technologies is essential for achieving the Sustainable Development Goals, including universal health coverage and the other “triple billion” targets in WHO’s 13th General Programme of Work. Such technologies are no longer a luxury; they are a necessity.” (Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization; WHO Guideline: Recommendations on Digital Interventions for Health Systems Strengthening, 2019)

• In 2005 the World Health Assembly through its resolution WHA58.28 on eHealth urged 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 2013, the Health Assembly adopted resolution WHA66.24 on eHealth standardization and interoperability, which urged Member States “to consider developing … policies and legislative mechanisms linked to an overall national eHealth strategy”.

• The global strategy on digital health builds on resolutions adopted by the United Nations General Assembly and the World Health Assembly, related WHO global and regional reports, regional strategies, the two-part report of the ISO Technical Committee on Health Informatics on eHealth architecture,

• Telemedicine is the delivery of health care services, where distance is a critical factor, by all healthcare professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health care workers, with the aim of advancing the health of individuals and communities.

• Telemedicine can contribute to achieving Universal Health Coverage (UHC) by improving access for patients to quality, cost-effective, health services wherever they may be. It is particularly valuable for those in remote areas, vulnerable groups and ageing populations. This is an enabler of healthcare access and affordability. Telemedicine can play an important role in cases where there is no absolute need for the patient to physically see a medical professional, e.g., routine check-ups, continuous monitoring as well as emergency situations. Telemedicine can reduce the burden on the hospitals. An international standard would support achieving universal health coverage by several countries.

• There may be some concern on practice of telemedicine due to either lack of guidelines, national regulatory framework, or absence of an international legal framework to allow health professionals to deliver services in different jurisdictions and countries. a lack of policies that govern patient privacy and confidentiality vis-a-vis data transfer, storage, and sharing of information between health professionals and jurisdictions; health professional credentialing, and the risk of medical liability for the health professionals offering telemedicine services. Therefore, the challenge remains whether telemedicine/ telehealth services are delivered in an appropriate manner ensuring all essential components of care as provided during in-person care in a health care facility. An international Quality Management System standard would support a telemedicine provider in pursuing a sound course of action to provide effective and safe medical care based on current evidence-based information, available resources, and patient needs to ensure patient safety.

• Health providers are already struggling to ensure quality and patient safety in a healthcare facility [The Lancet Global Health Commission (2018)] and therefore care provided through Telehealth adds to the risk. It is therefore become necessary to have a framework of requirements leading to the proper use of telehealth. An international standard would facilitate proper use of telehealth by a telehealth providers and systems.

• When all people, regardless of race, gender, income, social status and geographical distribution, have access to quality health care, the population becomes healthier and more productive. As a result, the population can reduce poverty and its associated consequences such as illiteracy, malnutrition, and illness. The workforce becomes healthier and national spending capacity increases.

• Health systems strengthening through quality management helps countries to achieve Sustainable Development Goals (1,3,8,10,12,13 and 17).

• The World Health Organization (2007) expressed that countries must make the case for “more effective investment in health systems in a competitive environment.” They elaborate that it is important to be able to show progress and desired improvements, and that measurable indicators are needed. An international standard would require measurable indicators and evidence of continuous improvement.

• COVID-19 Pandemic has forced the whole world to shut down including several services of healthcare. This has led thousands of patients globally not having access to care they needed. In response to COVID-19 Pandemic, many countries rise to the occasion and telehealth emerges as a game changer. It became helpful for home management of COVID patients as well as non-COVID patients, and supported containment of transmission of virus. To make telemedicine part of legitimate practice, strategy of notifying new regulation or amendment in the existing regulation was adopted in many countries.

• Several articles published in past few months have highlighted use and intricacies of telemedicine. (Ohannessian et al., Judd et al., Bobak et al., Anthony et al). An international standard based on global quality management system framework would support practice of telemedicine and telehealth systems in a manner to support Quality and Safety.

• International organizations may see a value to support this standard. The World Health Organization, World Trade Organization (WTO), World Bank, and the Organisation for Economic Co-operation and Development (OECD) have expressed partnerships and/or interests in ISO and health systems strengthening. This type of global standard is of benefit to each organization in some way (one motivation being financial).

• The WHO, OECD, and World Bank (2018) issued a call for action stating, “While no single actor will be able to effect all these changes, an integrated approach whereby different actors work together to achieve their part of the quality call to action will have a demonstrable effect on the quality of health services around the world.” A global ISO standard would serve as a point to bring actors together for a discussion, and hopefully action.

• ISO Action Plan for Developing Countries 2016 – 2020 expresses a commitment to support the strengthening of the national quality infrastructure in developing countries. This potential partnership represents a significant opportunity for partnering with ministries of health that would like to implement a global telehealth system quality standard. Stakeholders: Ministries of Health, Departments of Health Public and Global Health Researchers, Universities and Institutions Non-governmental agencies that provide health systems funding and resources (Bill and Melinda Gates Foundation, The Global Fund, The Clinton Foundation, GAVI the Vaccine Alliance, etc.) Intergovernmental agencies: The World Bank, World Trade Organization, OECD, World Health Organization, International Telecommunication Union (ITU) Switzerland Health system employees (healthcare providers and all laborers within the system)  Consumers/Patients International societies [(International Society for Telemedicine and e-Health (ISfTeH), International Society for Quality in Health Care (ISQua), International Accreditation Forum (IAF)] References World Health Organization, WHO Guideline: Recommendations on Digital Interventions for Health Systems Strengthening, 2019.

Available from: https://apps.who.int/iris/bitstream/handle/10665/311941/9789241550505-eng.pdf?ua=1 World Health Organization, Global Strategy On Digital Health 2020-2025.

Available from: https://www. who.int/docs/default-source/documents/gs4dhdaa2a9f352b0445bafbc79ca799dce4d.pdf World Health Organization, Telemedicine: opportunities and developments in Member States – report on the second global survey on eHealth. Global Observatory for eHealth series – Volume 2. Geneva: World Health Organization; 2010.

Available from: http://www.who. int/goe/publications/goe_telemedicine_2010.pdf Kruk ME, Gage AD, Arsenault C, Jordan K, Leslie HH, Roder-DeWan S, et al. High-quality health systems in the Sustainable Development Goals era: time for a revolution. Lancet Glob Heal [Internet]. 2018;6(November):1196–252.

Available from: https://linkinghub.elsevier. com/retrieve/pii/S2214109X18303863 World Health Organization, World Bank O. Delivering quality health services. A global imperative for universal health coverage [Internet]. 2018. Available from: http://apps.who.int/bookorders. Ngoma C, Mayimbo S. The Negative Impact of Poverty on the Health of Women and Children. Ann Med Heal Sci Res [Internet]. 2017;7:442–6.

Available from: https://www.amhsr.org/articles/thenegative-impact-of-poverty-on-the-health-ofwomen-and-children-4022.html United Nations. Sustainable Development Goals [Internet]. [cited 2019 May 2].

Available from: https: //sustainabledevelopment.un.org/?menu=1300 Ohannessian R, Duong TA, Odone A. Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action JMIR Public Health Surveill 2020;6(2):e18810.

Available from: https://publichealth.jmir.org/2020/2/e18810/PDF Judd E. Hollander, M.D., and Brendan G. Carr, M.D. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med 2020; 382:1679-1681.

Available from: https://www.nejm.org/doi/pdf/10.1056/NEJMp2003539?articleTools=true Bobak Moazzami, Niloofar Razavi-Khorasani, Arash Dooghaie Moghadam, Ermia Farokhi, Nima Rezaei. COVID-19 and telemedicine: Immediate action required for maintaining healthcare providers well-being, Journal of Clinical Virology, Volume 126, 2020,

Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7129277/ Anthony C Smith, Emma Thomas, Centaine L Snoswell, Helen Haydon, Ateev Mehrotra, Jane Clemensen, Liam J Caffery. Telehealth for global emergencies: Implications for coronavirus disease 2019 (COVID-19). J Telemed Telecare, 2020 Jun;26(5):309-313.

Available from: https://journals.sagepub.com/doi/full/10.1177/1357633X20916567

World Bank Group and ISO Partnership Highlights. How Countries Benefit from International Standards: Open Trade, Access to Markets and Innovation [Internet]. [cited 2019 Feb 21]. p. 2016.

Available from: http://www.worldbank.org/en/news/press-release/2016/03/10/world-bank-group-andiso-partnership-highlights-how-countries-benefit-from-international-standards ISO Action Plan for Developing Countries. 2016-2020 [Internet]. Geneva; 2016.

Available from: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100374.pdf