https://orcid.org/0000-0002-8370-9562
Introduction
According to the Food and Drug Administration (FDA), digital health tools are revolutionizing healthcare by enhancing diagnoses and treatments while streamlining global healthcare delivery systems. In 2023, the estimated value of the digital health market was around USD 245.3 billion. In contrast, the global digital transformation market, encompassing a broader range of technologies and services beyond just digital health, was valued at approximately USD 880.28 billion during the same yearCitation1.
Digital health encompasses the integration of technologies into health, healthcare, daily life, and society to improve the effectiveness of healthcare delivery and personalize treatments. This field includes technologies such as mobile health applications (mHealth), wearable devices, telehealth and telemedicine, as well as health information technology (IT) systemsCitation2–7.
Digital health, promising in transforming healthcare delivery, faces significant challenges across the worldCitation2. These challenges vary based on factors like socio-economic environment and technological infrastructure. In low- and middle-income countries (LMICs), issues largely pertain to infrastructure and systemic barriers, whereas in high-income countries (HICs) like the US, challenges include interoperability, cybersecurity, privacy, and misinformation. Interoperability, or the ability of different digital health systems to effectively work together, is hindered by inadequate standardization and data quality issuesCitation2.
The necessity for comprehensive digital health policies is evident, as they address barriers unique to each socio-economic and technological context and ensure the safe and effective implementation of digital health initiatives. Literature highlights the need for enhanced regulations, improved system integration and interoperability, increased healthcare provider training, and a commitment to user-cantered designCitation8. Addressing access disparities and digital literacy, especially among vulnerable groups, is crucial for maximizing the impact of digital health technologies in healthcare delivery and patient outcomes. Adapting digital health policies to these needs is essential for realizing their full potential.
This editorial aims to discuss the indispensable role of digital health policies in harnessing the full potential of digital health to improve health outcomes and healthcare delivery globally, with a specific focus on the varied contexts of LMICs and HICs.
Digital health policies in LMICs
Digital health policies in LMICs are essential for transforming healthcare systems, improving access, and enhancing quality. Key to their success are strong partnerships, user-cantered design, scalable technologies, policy alignment, sustainable funding models, and supportive infrastructure, which are often lacking in areas with inadequate traditional healthcare structures. For regions without sufficient infrastructure like hospitals or primary care clinics, digital healthcare provides vital access through telemedicine and mobile health applicationsCitation9.
Digital health technologies in LMICs offer significant advantages, including better disease surveillance and management. For instance, Nigeria’s SORMAS system shows how digital tools can strengthen responses to health crises such as infectious disease outbreaks; moreover, data-driven decision-making aids in shaping public health policies for effective, population-specific interventionsCitation10.
However, implementing digital health policies comes with substantial challenges. The digital divide is especially prominent in LMICs, where access to technology and internet connectivity is highly variableCitation2,Citation11. Additionally, safeguarding health data necessitates robust legal frameworks and technical solutionsCitation9,Citation12,Citation13. The success of digital health initiatives also hinges on investments in training and capacity building, as illustrated by Kenya’s M-TIBA platform, which underscores the importance of partnerships for scalingCitation14. Since its launch in 2016 by CarePay, Safaricom, PharmAccess, and UAP Insurance, M-TIBA has significantly impacted healthcare in Kenya. It functions as a mobile health wallet, allowing individuals to save, send, receive, and pay for treatment using their phones. This platform also enables friends and family to contribute funds specifically for healthcare expenses and provides a channel for subsidies and vouchers from donors. The funds allocated through M-TIBA are exclusively designated for use at participating clinics, ensuring that they are dedicated solely to healthcare purposesCitation14.
Economically, digital health policies in LMICs are acknowledged as catalysts for development. They help lower healthcare delivery costs, streamline administrative processes, and facilitate more cost-effective remote consultations, particularly vital for countries with constrained healthcare budgetsCitation15. Concurrently, they boost local technology sectors by creating jobs, enhancing skills, and attracting foreign investment, indirectly benefiting the economy by fostering a technologically adept workforce.
Nonetheless, these initiatives’ implementation challenges should not be underestimated. The significant initial investment for infrastructure and the ongoing expenses for training and system maintenance can strain limited resources, potentially exacerbating economic disparities. Unequal distribution of digital health services could counteract the broader economic benefits these policies aim to achieve.
LMICs face unique challenges related to healthcare providers and inefficient data management, such as a lack of availabilityCitation16,Citation17. These issues necessitate a tailored digital health policy framework, a point echoed across various studiesCitation2,Citation4,Citation5. However, most literature in this domain doesn’t focus on developing new frameworks but rather discusses existing implementation strategies, policy dimensions, and legal issues related to digital health. Effective digital health policy in these regions should holistically consider resource allocation, human and technical factors, and public policy elementsCitation16,Citation17. Without adequate legislation and policy, implementation at both organizational and professional levels becomes significantly harder. WHO’s framework emphasizes citizen protection, cybersecurity, and universal access to eHealth solutions. Efforts in LMICs to establish digital health policies and strategies tend to be disjointed and lack comprehensive integration, with organizations often operating autonomously. Sub-Saharan African nations show varied readiness for eHealth regulations, despite having legislationCitation16,Citation17. The status of regulations regarding eHealth in countries within Sub-Saharan Africa varies, with levels of preparedness and challenges in implementation. While certain nations such as Mauritius, Botswana, and the Seychelles have shown readiness, others face obstacles due to healthcare systems, inadequate governance, and diverse sources of healthcare financing. Despite the existence of eHealth strategies in countries, effective implementation is hindered by factors like a lack of leadership, regulatory hurdles, and the need for innovative policies. Examples of success can be seen in Rwanda’s use of drone technology for supply delivery, highlighting the benefits that come from adapting regulatory frameworks to new technologiesCitation16.
Digital health policies in HICs
Enhancing privacy and security in digital health is becoming a priority in high-income nations. Both in the US and EU, there is an increasing consensus on the need for robust policies like the General Data Protection Regulation (GDPR). GDPR’s impact in Europe, particularly in defining user rights and facilitating cross-border data sharing, highlights its importance in building trust and transparency in health data handlingCitation18. Similarly, Canada’s virtual care policy framework exemplifies a comprehensive approach, focusing on sustainability and efficiency in healthcare, with pivotal policies grounded in privacy, security, and equitable accessCitation19.
Standardization, interoperability, and equitable access also play a pivotal role in the evolution of digital health policy. Australia and Canada would particularly benefit from policies mandating uniform electronic health record formats and interoperability across various health systems. This not only facilitates data sharing but also improves coordination of care. Europe has recently adopted its Digital Health Action Plan, emphasizing strong governance mechanisms and harnessing technological innovations for better health outcomesCitation20.
The integration of AI and big data technologies in healthcare, especially across Europe, necessitates policies that address ethical considerations, uphold data quality standards, and define decision-making processesCitation21. The EU is addressing these challenges through frameworks like GDPR and proposed regulations such as the AI Act. GDPR regulates AI systems to an extent, focusing on personal data processing and protection against solely automated decision-makingCitation21. However, it does not specifically address all the regulatory needs of AI systems. This distinction underscores the necessity of the AI Act, which is designed to complement the GDPR by establishing specific rules for AI-driven products and services. The AI Act introduces a risk-based approach and technology-neutral definitions for AI systems in EU law, ensuring principles like technical robustness, privacy, data governance, human agency, transparency, and non-discrimination are adhered to, thus filling the regulatory gaps not covered by the GDPRCitation21.
The rise of COVID-19 has underscored the urgent need for clear guidelines and reimbursement policies in countries like the United States and Canada to enable the integration of telehealth into standard care, ensuring quality service provision and equitable compensation for providersCitation22.
Challenges in digital health across LMICs and HICs
In LMICs, challenges often stem from infrastructure and resources. For instance, many African nations face a divide where rural areas have limited access to internet connectivity and advanced technologies. This gap makes it difficult for areas without healthcare facilities to widely adopt digital health solutions such as telemedicine and mobile health applications. Additionally, LMICs often lack frameworks governing digital health, leading to concerns about data privacy and security.
On the other hand, HICs face challenges related to integrating advanced technologies, ensuring data security, and establishing standardized practices. In the United States, the main hurdle revolves around integrating and making digital health systems interoperable. Furthermore, as AI and big data become increasingly prominent in healthcare, HICs face considerations and the need for frameworks that strike a balance between innovation and safety/privacy.
Conclusion
To fully harness the power of digital health, it is crucial to develop nuanced policies that take into account the specific socio-economic realities of different regions. Although this editorial highlighted the challenges and priorities faced by both LMICs and HICs, there is a common thread that binds them together: the importance of ensuring equal access to the benefits of digital health.
For LMICs, it is necessary to establish policies that bridge the infrastructure gap and foster partnerships for developing technologies, thus closing the divide. It is vital to have frameworks for data privacy and security in place, striking a balance between safeguarding health information and encouraging innovation. By focusing on user-centered design and affordable solutions, LMICs can empower healthcare workers and citizens to embrace tools for healthcare outcomes. As for HICs, they face the challenges of integrating cutting-edge technologies such as AI and big data. It is essential to establish interoperability standards and data governance frameworks that ensure information flow while prioritizing patient privacy protection. Striking a balance between innovation and ethical considerations will play a role in harnessing these technologies’ full potential for impact.
Transparency
Declaration of funding
No funding was received to produce this article.
Declaration of financial/other relationships
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
None stated.
References
- Grand View Research. Digital Health Market Size, Share & Trends Analysis Report By Technology (Healthcare Analytics, mHealth, Tele-healthcare, Digital Health Systems), By Component (Software, Hardware, Services), By Region, And Segment Forecasts, 2023–2030 [Internet]. 2023. Available from: https://www.grandviewresearch.com/industry-analysis/digital-health-market.
- Al Meslamani AZ. Gaps in digital health policies: an insight into the current landscape. J Med Econ. 2023;26(1):1266–1268. doi:10.1080/13696998.2023.2266955.
- Al Meslamani AZ. How AI is advancing asthma management? Insights into economic and clinical aspects. J Med Econ. 2023;26(1):1489–1494. doi:10.1080/13696998.2023.2277072.
- Al Mazrouei N, Ibrahim RM, Al Meslamani AZ, et al. Virtual pharmacist interventions on abuse of over-the-counter medications during COVID-19 versus traditional pharmacist interventions. J Am Pharm Assoc (2003). 2021;61(3):331–339. doi:10.1016/j.japh.2021.02.003.
- Al Meslamani AZ, Kassem AB, El-Bassiouny NA, et al. An emergency plan for management of COVID-19 patients in rural areas. Int J Clin Pract. 2021;75(10):e14563. doi:10.1111/ijcp.14563.
- Al Meslamani AZ, Jarab AS, Ghattas MA. The role of machine learning in healthcare responses to pandemics: maximizing benefits and filling gaps. J Med Econ. 2023;26(1):777–780. doi:10.1080/13696998.2023.2224018.
- Al Meslamani AZ, Aldulaymi R, El Sharu H, et al. The patterns and determinants of telemedicine use during the COVID-19 crisis: a nationwide study. J Am Pharm Assoc (2003). 2022;62(6):1778–1785. doi:10.1016/j.japh.2022.05.020.
- Abernethy A, Adams L, Barrett M, et al. The promise of digital health: then, now, and the future. NAM Perspect. 2022;2022. doi:10.31478/202206e.
- Labrique AB, Wadhwani C, Williams KA, et al. Best practices in scaling digital health in low and Middle income countries. Global Health. 2018;14(1):103. doi:10.1186/s12992-018-0424-z.
- Bode M, Goodrich T, Kimeu M, et al. Unlocking digital healthcare in lower- and middle-income countries [Internet]. 2021 [cited 2023 Oct 27]. Available from: https://www.mckinsey.com/industries/healthcare/our-insights/unlocking-digital-healthcare-in-lower-and-middle-income-countries.
- Al Meslamani AZ. Technical and regulatory challenges of digital health implementation in developing countries. J Med Econ. 2023;26(1):1057–1060. doi:10.1080/13696998.2023.2249757.
- Al Meslamani AZ. Economic benefits of global collaborative health technology. Expert Rev Pharmacoecon Outcomes Res. 23;1–3. doi:10.1080/14737167.2023.2263649.
- Al Meslamani AZ. Advancing towards a worldwide healthcare system in the post-COVID-19 era: benefits and barriers to international collaboration in healthcare. J Med Econ. 2023;26(1):679–681. doi:10.1080/13696998.2023.2207423.
- M-Tiba [Internet]. [cited 2024 Jan 3]. Available from: https://mtiba.com/
- Gentili A, Failla G, Melnyk A, et al. The cost-effectiveness of digital health interventions: a systematic review of the literature. Front Public Health. 2022;10:787135. doi:10.3389/fpubh.2022.787135.
- Mengiste SA, Antypas K, Johannessen MR, et al. eHealth policy framework in low and lower middle-income countries; a PRISMA systematic review and analysis. BMC Health Serv Res. 2023;23(1):328. doi:10.1186/s12913-023-09325-7.
- Stroetmann K. Digital health ecosystem for African countries: a guide for public and private actors for establishing holistic digital health ecosystems in Africa. 2018.
- Vukovic J, Ivankovic D, Habl C, et al. Enablers and barriers to the secondary use of health data in Europe: general data protection regulation perspective. Arch Public Health. 2022;80(1):115. doi:10.1186/s13690-022-00866-7.
- Government of Canada. Virtual care policy framework [Internet]. 2021 [cited 2023 Dec 5]. Available from: https://www.canada.ca/en/health-canada/corporate/transparency/health-agreements/bilateral-agreement-pan-canadian-virtual-care-priorities-covid-19/policy-framework.html#:∼:text=,in. the delivery of care
- WHO. Countries in the European Region adopt first-ever digital health action plan [Internet]. 2022 [cited 2023 Dec 5]. Available from: https://www.who.int/europe/news/item/13-09-2022-countries-in-the-european-region-adopt-first-ever-digital-health-action-plan#:∼:text=Health. ministers and delegates from,being
- Meszaros J, Minari J, Huys I. The future regulation of artificial intelligence systems in healthcare services and medical research in the European union. Front Genet. 2022;13:927721. doi:10.3389/fgene.2022.927721.
- Breton M, Sullivan EE, Deville-Stoetzel N, et al. Telehealth challenges during COVID-19 as reported by primary healthcare physicians in Quebec and Massachusetts. BMC Fam Pract. 2021;22(1):192. doi:10.1186/s12875-021-01543-4.