A new law regulating the use of technology in healthcare is the first piece of federal legislation in the United Arab Emirates that directly addresses data protection principles. The new rules will be relevant to healthcare providers, insurers and companies delivering healthtech solutions into the UAE market.
UAE Federal Law No. 2 of 2019 concerning the use of information and communication technology in the area of health (the Law) will come into effect in May this year. The Law regulates the use of electronic data in the healthcare sector throughout the UAE, with certain administrative, strategic and enforcement functions devolved to local Emirate health authorities and it reflects a number of principles found in international data protection laws. The Law introduces legal requirements that businesses will need to be aware of. Affected organisations will clearly include healthcare providers but also medical insurance businesses, healthcare IT system suppliers and providers of outsourced services to the health sector, such as cloud service providers.
Key features of the Law include:
- Establishment of a central IT system and mandatory interoperability standards for the health sector throughout the UAE
- Creation of a national IT strategy for healthcare
- Creation of "data protection" obligations and restrictions, in particular in relation to confidentiality, integrity, sharing, storage and retention
- Derogations from data sharing restrictions to promote scientific and clinical research and to allow necessary exchange of information with the insurance industry
- Establishment of disciplinary committees within each local Emirate health authority to enforce the law and apply sanctions for breach
In this section, we set out some more detailed analysis of some of the key elements of the Law.
A. Central IT system
A key building block
A centrally controlled (by the Ministry of Health and Prevention) healthcare IT system will be developed. The system is for the collection and exchange of healthcare data, to enable healthcare organisations to access data in a uniform and secure way, subject to the controls determined by the government. The creation of a secure method for healthcare data exchange and a set of common interoperability standards is to be welcomed. Future advances in healthtech will often be highly data-reliant and it has been recognised globally that interoperability, data centralisation and confidentiality, as well as commonality across record keeping, are key challenges for any country which wishes to have a genuinely high-tech and state of the art healthcare environment. By way of example, the National Health Service in the UK (NHS) has a chapter of its Long Term Plan dedicated to digitally enabled healthcare and recognises the importance of connected digital systems and the need for interoperability standards to achieve this. A key foundation of the NHS' digital capability is the NHS "Spine" system, which is a secure central system for information sharing; this looks to be a clear parallel to the central system to be developed under the new UAE law.
Direct access to the system will be restricted to organisations authorised by the local health authority under executive regulations. It will be important for the health industry that the regulations are clear in relation to who is authorised, and indeed required, to use the central system and what administrative steps must be taken. For example, will pharmacists be required to upload any patient details, particularly in relation to the distribution of certain controlled medicines, or are pharmacists out of scope as far as the central system requirements are concerned? Will there be any quality-control thresholds that businesses will need to pass to obtain access? Can providers of services to the industry obtain authorisation or is authorisation restricted to primary healthcare providers only? Can primary providers delegate their own access to outsourced service providers?
Responsibility and cost
Typically, access to centralised systems – such as the planned healthcare system – is facilitated by open APIs (application programme interfaces) being made available to third party suppliers of IT systems which will need to access the system. Where those IT systems already exist and are in use (under contracts between healthcare providers and the suppliers), technical changes to the systems will be required.
Such suppliers may look to pass on the system change and integration cost to their customers. Ultimately, this cost would then be passed on to the end user consumer (the patient). The publishing of open integration standards and the need for legacy systems to be updated or replaced may, however, stimulate increased competition amongst system suppliers. A competitive market for healthcare IT system suppliers will be important for cost control and the avoidance of "lock in" over longer periods.
From a legal standpoint, it is important to be clear whether the interoperability requirements apply directly to healthcare IT system suppliers. This would mean the risk of a non-compliant system (due to inability to interact with the central system) is shared between healthcare providers and their IT suppliers. If the legal compliance burden falls solely on the healthcare providers then the legacy third party system suppliers, which are required by their customers to make system changes under existing contracts, have little incentive to control cost, knowing their customers have no choice but to pay for the work. IT providers might argue that if they are required to maintain a version of their system that is country-specific from a compliance perspective, overall costs will increase and that it makes sense for costs to flow-down in the way previously described above.
An important challenge for the executive regulations will be to find a pathway which enables timely delivery of system changes over a realistic transition period without resulting in material cost increases which inhibit access to healthcare.
B. Data protection obligations
Confidentiality and security
Businesses will need to ensure that access to their data is properly controlled and only authorised personnel who understand the need for patient confidentiality are given access. Businesses will also need operational and technical procedures to ensure the integrity and security of data. These requirements are in keeping with international data protection norms and are increasingly reflected across the Middle East via the proliferation of new data protection laws. This is a trend we would expect to continue and, in the UAE, to ultimately extend beyond the healthcare sector.
International processing / storage
The Law, at Article 13, prohibits the storage and processing outside the UAE of health data related to services provided within the UAE. However, the prohibition can be lifted by a resolution issued from the local Emirate health authority in coordination with the government ministry. This restriction could clearly present challenges for any businesses which currently rely on data storage or processing outside the UAE (for example, via cloud services or hosting services) and indeed for businesses which currently offer such services into the UAE market.
We would encourage industry to engage with the health authorities at the earliest opportunity to seek clarity around this area, in particularly what is envisaged in terms of the permissive resolutions and whether or not there will be an additional transitional period.
Article 20.1(A) appears to require healthcare bodies to retain all health data for at least 25 years following the most recent point of contact with the patient. This could create an increasing storage burden for businesses and businesses will need to ensure they have the capability and systems to comply.
C. Sanctions for breach
Loss of ability to practise
Article 25 sets out disciplinary sanctions (in addition to certain other Articles which set out a regime of fines for certain violations of the law). The sanctions include, at paragraphs (D) and (E), the potential suspension or withdrawal of the licence to use the central IT system. Presumably loss of such use would render a healthcare provider unable to lawfully run a practice. It is therefore vitally important that businesses active in this area familiarise themselves with the law, follow closely the development of the executive regulations and take all opportunities to communicate and consult with the ministry and the local health authorities.
Key compliance steps
Some businesses may need to change the way they operate or revisit their business procedures in order to comply with the Law. Key compliance steps will include the following:
- Keep up to date with the executive regulations which are to be published within six months, setting out further details
- Ensure IT systems are capable of interacting with the central IT system
- Complete any necessary administrative steps to obtain access to the central IT system, such as registration / licensing requirements
- Have technical and organisational processes in place to ensure that all patient data is treated confidentiality, kept secure, kept accurate and uncorrupted, not used for other purposes and retained as required
- Not transfer or store any patient data outside the UAE unless authorised to do so by a resolution issued by the local health authority