Sahar Iqbal
Akhand Forbes, Karachi
sahar.iqbal@akhandforbes.com

Introduction

Pakistan's healthcare landscape is undergoing a transformative shift propelled by the burgeoning digital health sector. With the advent of innovative technology and an increasing desire for effective healthcare solutions, the nation is witnessing the rise of digital platforms, telemedicine services and health information systems. Despite this positive progress, the sector faces some legal and regulatory challenges.

Digital health framework

The digital health sector in Pakistan is in its early stages of development, owing to emerging technologies and rising need for effective healthcare solutions. While digital health is not explicitly defined in Pakistani law, the National Digital Health Framework 2022–2030 (NDH Framework) follows the World Health Organisation (WHO) definition, as ‘the field of knowledge and practice associated with the development and use of digital technologies to improve health’. Telemedicine, telehealth, mobile health and e-pharmacies are examples of important new digital health technologies in the private sector. To improve healthcare governance and resource management, the public sector is increasingly using electronic health records, health information systems, big data analytics, artificial intelligence (AI) and cloud computing.  

However, Pakistan's federal structure complicates regulatory compliance because legislative responsibilities are shared between the federal government and provincial assemblies. This results in distinct legal frameworks for regulating healthcare across areas, forcing digital health service providers to traverse several regulatory regimes. This is evident from the fact Pakistan as a federation lacks a dedicated legal framework for regulating digital health, however, the Sindh Province has enacted the Sindh Telemedicine and Telehealth Act 2021 (STTA). The STTA requires medical professionals to practice telemedicine or telehealth after finishing an online course and registering with the registry created by the STTA. It also highlights the privacy and security of patients' health information, requiring service providers to use adequate security safeguards to secure such information. Additionally, legislative responses to technological changes in the healthcare sector are delayed, resulting in antiquated legislation that is frequently incompatible with cutting-edge digital health solutions. This hampers the efficiency of digital health solutions and causes ambiguity among stakeholders.

Despite these limitations, Pakistan's digital health sector shows promise, particularly following Covid-19. While official market size numbers are lacking, estimations indicate that the country spends a significant amount of money on healthcare, with a large chunk of that going into retail pharmaceutical purchases and outpatient services, which are sectors targeted by digital health service providers. Sehat Kahani, Dawaai, Healthwire, Ailaaj and Marham are now the dominant startups in the digital healthcare industry. However, due to their private status, these companies' specific income figures are unknown, making it difficult to assess their financial health and market domination.

Regulatory regime

In Pakistan, the regulatory landscape for digital health is evolving, despite the lack of a specialised national legal framework. However, the Sindh Telemedicine Act stands out as a trailblazing piece of law that regulates specific aspects of digital health, particularly telemedicine services. This Act requires medical professionals to complete specified training and registration before practicing telemedicine, with an emphasis on patient data protection and security.

While the lack of comprehensive legislation is significant, existing federal and provincial laws, such as the Drug Regulatory Authority of Pakistan Act 2012 (DRAP Act), provides a regulatory framework for digital health products and services. The DRAP Act governs the manufacture, importation and sale of therapeutic goods, including medical devices and ensures that quality criteria are met.

Furthermore, different regulatory authorities play important responsibilities in enforcing these regulations. The DRAP is in charge of registering therapeutic items and ensuring their quality, whereas the Pakistan Telecommunication Authority (PTA) supervises digital health products that use frequency spectrum. Provincial health agencies, the Pakistan Medical and Dental Council (PMDC) and Health Care Commissions play important roles in upholding healthcare standards and professional ethics. The Pakistan Medical and Dental Council Act 2022 (PMDC Act) governs the medical profession and its practitioners in Pakistan. The Professional Ethics and Code of Conduct issued by the PMDC, established under the PMDC Act, contains instructions for practicing medicine via web-based telemedicine sites, with a strong emphasis on patient privacy. It strictly prohibits the transfer of such information to another jurisdiction without informed consent. In addition, the Prevention of Electronic Crimes Act 2016 (PECA) is important in regulating digital health because it prohibits unauthorised access to information systems or data and regulates online offences including identity theft and fraud.

It is important to note that enforcement actions are primarily focused on enforcing compliance with quality standards, professional credentials for healthcare practitioners, patient health information protection and adherence to cybersecurity measures required by PECA. However, the regulatory landscape is complicated by the lack of a complete legal framework, the tardy legislative response to technical changes and the need for clarity in the classification and approval processes for software as a medical device. Overall, as Pakistan's regulatory framework for digital health evolves, stakeholders must negotiate existing rules and regulations to maintain compliance while pressing for comprehensive legislation to address the sector's specific issues and potential.

Conclusion

In conclusion, Pakistan's digital health sector shows promise for revolutionising healthcare delivery in the country. Despite confronting complicated legal and regulatory challenges, such as the lack of a comprehensive national framework and the complexities of managing federal-provincial legislative obligations, significant progress has been made, particularly with the passage of the STTA. The rise of innovative businesses and the adoption of cutting-edge technologies demonstrate the sector's ability to address healthcare concerns and enhance access to excellent services. As regulatory frameworks change and stakeholders push for comprehensive legislation, Pakistan's digital health industry is set for considerable growth and influence, paving the way for a healthier and more accessible future for all citizens.