Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
Zahir Qayum - Senior Counsel - Employment and Incentives
Bahrain’s Law on the Protection of Personal Data was published on 19 July 2018, and will come into effect on 1 August 2019. The Law will require a variety of changes to the way businesses process personal data in Bahrain or about residents of Bahrain. Data protection has not been a high priority topic for most businesses in Bahrain, with the limited exception of international entities subject to data protection requirements in other jurisdictions in which they operate. While the publication of the new Law provides a considerable lead-in period within which entities subject to the Law will need to comply, the fact that the Law creates criminal offences means that compliance is all the more important and should be treated as a high priority.
Until now, and with one exception (namely, Qatar), none of the Gulf Cooperation Council member states had a modern, nationally applicable data protection law. Legal issues relating to privacy and data protection are typically analysed in terms of general, and ill-fitting, criminal provisions relating to the unauthorized disclosure of secrets, or – in appropriate circumstances – industry-specific obligations relating to healthcare or credit data, or telecommunications sector subscriber data.
The Law is generally composed of 60 articles divided into three broad sections or ‘titles’. These are:
In this article, we consider some key areas addressed in the Data Protection Law.
Bahrain’s Data Protection Law describes the legal protection of personal privacy as among the main constitutional rights of the person, and notes that it should be protected, particularly in the context of the increasing use of electronic/digital means for processing information.
The Law applies to:
In this latter scenario, the legal person (corporate) is required to appoint an authorized representative in Bahrain, and notify the Authority of such appointment. This provision would appear to affect, for example, corporate customers of cloud service providers, where the customer is based outside Bahrain, and the services being provided to the customer are being provided from data centres located in Bahrain.
The Law criminalizes a variety of acts that would, at most, be the subject of administrative penalties in data protection laws elsewhere. Penalties generally comprise up to one year in prison and/or a fine of between BHD1,000 and BHD20,000 (between about USD 2,600 to about USD 53,000) (or a fine only in the case of corporate entities). The following are examples of activities that attract criminal penalties under the Law:
Generally, the security of processing provisions, and the confidentiality provisions, appear to be fairly standard.
Data controllers are required to apply technical and organizational measures capable of protecting personal data against unintentional or unauthorized destruction, accidental loss, unauthorized alteration, disclosure or access, or any other form of processing. The measures adopted need to be appropriate, bearing in mind the nature of the data in question and the risks associated with processing it. The Law also indicates that ‘state-of-the-art’ technological protection measures should be adopted, but this is tempered by reference to the costs arising from use of such technology.
Additionally, the Law contemplates the issuance of a regulation specifying requirements that technical and organisational measures must satisfy. It also provides scope for specific requirements to be prescribed in such regulations.
Data controllers are required to maintain documentation that reflects the technical and organizational measures adopted. This documentation must be available for viewing by the parties concerned (presumably, including data subjects), as well as the Authority, any data processors, and the data controller itself.
With regard to processing by data processors, the Law requires data controllers to engage only data processors who provide sufficient guarantees regarding the application of technical and organisational measures. Importantly, there is an obligation on data controllers to take steps to verify compliance with such measures, and to enter into a written contract with the data processor requiring that the data processor shall only process data in accordance with the instructions of the data controller, and in accordance with the data controller’s requirements with regard to security and confidentiality.
There does not appear to be any specific obligation to notify the Authority in the event of a data breach incident. It is possible that this level of detail might be addressed in the regulations, or that the Authority is expected to address breaches only in the event that they become aware of them, and the circumstances indicate a breach of the obligation to use suitable technical and organizational security measures.
Data protection supervisor
The Law contemplates a role of ‘Data Protection Supervisor’ (which is not a data protection officer) intended to act as an independent and impartial intermediary between the data controller and the Authority.
The data protection supervisor will help the data controller fulfil its rights and obligations, and coordinate between the data controller and the Authority. It will also be required to verify the data controller’s processing in compliance with the law, alert the data controller to any apparent non-compliance to enable the issue to be addressed, and alert the Authority where such non-compliance has not been addressed within a specified timeframe. The data protection supervisor will also be required to maintain a register of the data controller’s processing operations that the data controller must notify the Authority, and update the Authority of the same on a monthly basis. (If no data protection supervisor is appointed, then the data controller is required to do this itself.)
The qualifications and requirements for registration as a data protection supervisor will be officially issued, and data protection supervisors will need to be registered on a register maintained by the Authority. The requirement to appoint a data protection supervisor is optional, although it may be made compulsory for specific categories of data controllers.
The concept of a data protection supervisor has the potential to result in a whole new industry in the Bahrain market. The regulations setting out the requirements for the registration of data protection supervisors may shed greater light on what is anticipated, in terms of who might be able to fulfil such roles. The most natural development may be for the role to be filled by consulting/audit firms with expertise in data protection related issues.
Bahrain’s new Data Protection Law will require a great deal of attention from businesses operating in Bahrain. Data protection has not been a high priority topic for most businesses in Bahrain, with the limited exception of international entities subject to data protection requirements in other jurisdictions in which they operate. While the publication of the new Law will result in some degree of a lead-in period within which entities subject to the Law will need to comply, the fact that the Law creates criminal offences means that compliance is all the more important and should be treated as a high priority.