The first Law Update of 2024 is here, and our first focus of the year spotlights Healthcare and Lifesciences, a sector that is undergoing significant growth and development across the MENA region.
Our focus provides an insight into some of the most important regulatory updates across the region, such as the UAE’s groundbreaking law on the use of human genome, Kuwait’s resolution on nuclear and radioactive materials, the new regulations for healthcare services in Qatar, Egypt’s healthcare regulatory framework, and the impact of the Saudi Civil Transactions Law on the healthcare and life sciences sector … and there is so much more!
Beyond the healthcare pages our lawyers share with you multi-sector insights where you will discover articles on Dubai’s DIFC regulatory framework for startups, Bahrain’s commercial agencies law, and we also shed light on Kuwaiti civil code and the advantages of setting up a joint stock company in Saudi Arabia.Read the full edition
It is timely that the Health Authority – Abu Dhabi has recently introduced regulations to define minimum standards for telemedicine as a means to provide healthcare services to patients in the Emirate of Abu Dhabi.
What is Telemedicine?
The term “Telemedicine” generally refers to the use of information and communications technology to transfer medical information from one site to another to improve a patient’s clinical health status.
Remote diagnosis and consultation through the application of telecommunications is not a new phenomenon. For example, back in the 1930s pioneers living in remote areas of Australia used two-way radios to communicate with the Royal Flying Doctor Service.
However advances in technology together with the growing availability of broadband on ultra fast fiber and 4G mobile networks means that right now telemedicine is rapidly evolving to cover a variety of applications using voice, video or image data.
Patient consultations via video conferencing, transmission of medical images, remote patient monitoring, e-health patient portals and continuing medical education are all now part of telemedicine.
Although most medical specialities lend themselves, at least in part, to having evaluations performed using telemedicine, specialities that require less direct patient contact, such radiology or pathology, have to date tended to be the best candidates for telemedicine.
Now mobile telemedicine is posed for significant innovation. While there are already many consumer focused telemedicine apps available, with big brands like Apple and Samsung making significant pushes into the area, telemedicine could soon become a mainstream proposition.
Apple recently unveiled its new Health app for health and fitness data and a cloud-based information platform known as “HealthKit” that can integrate data from across different providers and which is open to developers. HealthKit has been included by Apple in iOS8 the iPhone’s new operating system that has just been released in conjunction with the iPhone 6.
Apple has also announced “partnerships” with a number of large healthcare institutions for developing consumer facing healthcare apps. These partners include Epic Systems, one of the largest suppliers of electronic medical record systems in the United States.
Samsung has unveiled a new hardware reference design called Simband for developers building devices or applications that leverage data captured through wrist‒worn sensors (either Samsung’s or other manufacturers). The Simband connects to Samsung’s new, open source SAMI platform, which uses a mix of hardware and a cloud backend for sensor data. Samsung hopes its new software platform will bring together data from various sources to provide more helpful health data analysis
The principle benefits of telemedicine include:
By contrast, one of the main disadvantages with telemedicine is the perceived risk that personal health information may be compromised by transmission and offsite storage.
Regulators around the world have sought to set standards that balance enhancing the portability of personal health information for the better integration of health services, while at the same time improving accountability to protect the confidentiality of that shared information.
For example, in the US the Health Insurance Portability and Accountability Act 1996 sets out privacy and security standards for the use and distribution of health care information. The privacy rules regulate the use and disclosure of personal health information, while the security rules impose administrative, physical and technical security safeguards for electronic personal health information.
HAAD Telemedicine Regulations for the Emirate of Abu Dhabi
Consistent with the Abu Dhabi Economic Vision 2030 to develop a robust, world-class healthcare sector in the Emirate, in recent months the Health Authority – Abu Dhabi (“HAAD”) has introduced regulations to define minimum standards for telemedicine as a means to provide healthcare services to patients in the Emirate of Abu Dhabi.
The HAAD Service Standards for Tele-counseling in the Emirate of Abu Dhabi, which came into effect on 25 November 2013 (“Tele-counseling Standard”), defines minimum standards for the use of tele-counseling and aims ensure the integrity of physician – to – physician counseling conducted via telemedicine interfaces.
The HAAD Standards for Tele-consultation in the Emirate of Abu Dhabi, which came into effect on 20 March 2013 (“Tele-consultation Standard”), defines minimum standards for the use of tele-consultation and aims to ensure the quality and safety of physician – to – patient telemedicine services.
Important features of the Tele-consultation Standard are, amongst other things:
Key features of the Tele-counseling Standard are:
Under the Tele-counseling Standard and the Tele-consultation Standard the healthcare facilities and the healthcare providers respectively have to ensure that the telemedicine services meet certain technical standards, including:
Teleradiology Services in Dubai
Since 2012 the Dubai Health Authority (“DHA”) has regulated the use of the specific telemedicine service of “teleradiology” in Dubai under the DHA Diagnostic Imaging Services Regulation. “Teleradiology” is defined in the DHA regulation as the transmission of diagnostic images and related data from one location to another for the purposes of interpretation or consultation.
Amongst other things, the DHA’s teleradiology standards have express requirements as to the personnel at the transmitting site and the receiving site. The transmitting site should comprise of at least one full time radiologist, one radiographer and a system manager with informatics certification, whereas the receiving site should employ a radiologist licensed in the country the service is provided.
Telemedicine is emerging as a significant service delivery mechanism for healthcare in the 21st century. Telemedicine’s growing potential also raises a number of legal, clinical and technical questions for regulators. HAAD has recently responded by setting minimum standards for telemedicine as a means to provide healthcare services to patients in the Emirate of Abu Dhabi. The DHA has regulated the use of the specific telemedicine service of teleradiology in Dubai since 2012.