Welcome to the Saudi Arabia focus edition of Law Update.
One of the key markets in the Middle East and North Africa (MENA) that continues to lead from the front is the Kingdom of Saudi Arabia (KSA). As the largest country in the Middle East and the 18th largest economy in the world, the progress KSA continues to make is underpinned by its Vision 2030 that envisions developing the country as an investment powerhouse and hub that ultimately connects Asia, Europe, and Africa. Given Saudi Arabia’s significance to the regional economy, our team of experts have prepared a range of pertinent articles that provide insights into new laws, regulations, and the legal landscape in the Kingdom.
This edition will provide you with an up-to-date guide on matters such as; the framework issued by the Saudi Central Bank on IT governance, the anti-corruption landscape under Vision 2030; we also provide practical tips for dispute avoidance. This is only a snapshot; there are many more articles within the KSA focus section for you to read, which we hope you will find valuable and enjoyable.Read the edition
December 2015 – January 2016
One of the biggest concerns for the healthcare sector in the Gulf countries is the shortage of experienced healthcare professionals. Elsewhere there is a proficient baseline of qualified and experienced providers who routinely use telemedicine as a gateway to offer easier access to healthcare services and create efficiencies in the healthcare system. In the Gulf countries, we consider telemedicine to be the jump-start solution to expanding the reach of experienced healthcare professionals, and to tap into the advances made in other countries.
Telemedicine is being used across the world to connect patients in rural and underserved areas to highly qualified physicians and specialists who are miles away. Advances in technology and the growing availability of broadband on ultra-fast fiber and 4G mobile networks creates multiple channels for telemedicine. Patient consultations via video conferencing, transmission of medical images and remote patient monitoring are three examples of telemedicine yet the applications are vast. While other countries, such as the US, are more advanced in their telemedicine frameworks, confidentiality requirements and data protection standards, the promise is that the Gulf countries will mirror many of these developments and implement similar standards. Yet, at this time, the use of telemedicine is in its infancy.
Growth of the sector
Globally, the eHealth market is growing at a compound annual growth rate of 12 – 16% and is estimated to be worth $160 billion as of the end of 2015.
The Gulf countries have witnessed a tremendous increase in the demand for healthcare services. Technological advances need to keep up with demand for services to achieve and maintain efficient and quality healthcare. The rise in lifestyle diseases and the increasing number of resources required calls for a solution that allows easy and speedy access to healthcare, irrespective of the location of the patient in question. If the Gulf countries are to keep residents from seeking treatment overseas and meet their long-term strategy of providing access to high quality treatment, then cost efficient and effective healthcare is key. Across the Gulf countries, governments are creating new initiatives for telemedicine and recruiting private partners to join them.
Recent issues with telemedicine regulation
Inconsistent regulation of telemedicine services across the region is partly responsible for their slow growth. In this article, we principally give examples relevant to the UAE, but these issues are typical across the region.
In the UAE, we already see a great deal of inconsistency in the availability of telemedicine services. In Dubai, the Dubai Health Authority (‘DHA’) regulations only provide for teleradiology services through telemedicine-approved facilities. Several already operate under these regulations. In Abu Dhabi, the Health Authority – Abu Dhabi (‘HAAD’) regulations provide a framework for a wider range of telemedicine services under defined minimum standards and a specific telemedicine facility licence. One limitation is that telemedicine providers cannot prescribe medications. Patients must still attend an in-person consultation if the outcome of the telemedicine consultation is a treatment plan that could require prescription medication. The following focuses on aspects currently topical in the UAE but the theme is equally applicable to other countries in the region:
Outsourcing diagnostic imaging services – teleradiology
In Dubai, prior approval from the DHA is required to perform teleradiology services. Teleradiology is defined in the DHA imaging regulation (‘Imaging Regulation’) as the ‘transmission of diagnostic images and the related data from one location to another for the purposes of interpretation and/or consultation.’ The difficulty insofar as telemedicine is concerned is that the teleradiology transmitting site is required to meet the full diagnostic imaging facility requirements to include at least one full-time radiologist, one radiographer and a system manager with an informatics certification. Additionally, the teleradiology receiving site must employ teleradiology-certified radiologists licensed in the country where the service is provided.
The Imaging Regulation further details that both sites should hire information technologists and technicians who will be responsible for the computer systems and infrastructure. The qualifications of the personnel in the receiving site should be identical to those of the transmitting site. This doubling-up of the personnel required to provide the service does not make the service particularly cost efficient for the local licensed facility.
Diagnostic imaging healthcare professionals
Diagnostic imaging professions must hold a licence in order to work in the UAE. The healthcare professional licensing requirements are designated in the Healthcare Professionals Qualification Requirements 2014 (‘PQR’). The PQR does not identify a special telehealth-related licence that must be obtained by physicians intending to practise in such areas. Any licensing requirements for telehealth-related activities are the standard requirements for the corresponding scope of the practice. For example, a physician with a radiology specialty would be required for radiology services.
Diagnostic imaging facility staffing
The availability of appropriate and sufficient numbers of healthcare professionals on duty to plan, supervise and perform the diagnostic imaging procedures is required at the local facility. The Imaging Regulation denotes the minimum staffing requirements for various types of facilities. The law currently does not permit a relaxation of staffing requirements at the local facility after services have been outsourced via a telemedicine arrangement. Accordingly, it is necessary for the local facility to make an application to the local health authority for approval of the use of teleradiology services and to specifically lay out the justification for the number and qualifications of healthcare professionals chosen to plan, supervise, and perform the procedures at the transmitting site.
Diagnostic imaging facility licensing
Prior to establishing a healthcare facility in the UAE two licences are needed – a commercial licence and a facility licence – both with different requirements. A licence for a healthcare facility will not be granted without approval from the DHA. Further, a commercial licence must also be obtained. In order to obtain a commercial licence for a diagnostic imaging facility, certain structural, staffing, and other requirements must be met. No specific variation of the specified staffing requirements is currently catered for under existing laws, such that, should a facility wish to cut back on staffing in order to outsource services under a telemedicine arrangement, this can only be accomplished with the approval of the local health authority.
Outsourcing clinical laboratory services – telepathology
The outsourcing of clinical laboratory services is specifically permitted in Dubai and Abu Dhabi; however, the regulations are not clear on the question of whether the outsourcing can be arranged with laboratories outside the UAE. In Dubai, for example, the Clinical Laboratory Regulation 2012 (‘Laboratory Regulation’) states that test results must be approved and signed by the designated DHA-licensed laboratory staff. Arguably such language would not prevent a second opinion, including one that is outsourced to outside the country, and a review of the test results prior to a DHA-licensed member of the laboratory staff signing the report and bringing the entire process into compliance with the Laboratory Regulation.
There remains a significant gap between the traditional laws that govern the establishment and ‘setup’ of a healthcare business, on the one hand, and the telemedicine laws on the other. For example, a local healthcare provider must demonstrate that it has the requisite number of employed radiologists and radiographers at its facility, but if it later adopts telemedicine services and outsources radiology services via a telemedicine provider, there is no relaxation of the rules with regard to the number of on-site employed personnel. This situation clearly impacts upon the question of whether the outsourcing of those services is a cost-effective option. As this issue is becoming increasingly more common and as outsourcing via telemedicine services grows in popularity, local health authorities should be consulted about outsourcing plans and their approval sought to enable a down-scaling of requirement for on-site support.
A version of this article was originally published in eHealth Law & Policy – October 2015. http://www.e-comlaw.com/ehealth-law-and-policy/