Brighter receives clarification from the United Arab Emirates Ministry of Health and Prevention regarding data storage and processing in Actiste® Diabetes Management Solution
Brighter AB (Publ) (“Brighter” or “the Company”) announced today that the United Arab Emirates (UAE) Ministry of Health and Prevention (MoHAP) has notified the Company of a preliminary assessment clarifying certain matters relating to data storage and processing in Actiste® Diabetes Management Solution. On the basis of a technical evaluation, MoHAP considers that Brighter’s Actiste® device falls under the “simple device” categorization (pursuant to Ministerial Decision No. 51/2021 (the "Decision") providing for exemptions under UAE Federal Law No.2 of 2019 (“Health Data Law”)). Provided this device categorization applies, the data storage elements in Brighter’s Actiste® Diabetes Management Solution will be exempt from the current data localization requirements in the Health Data Law in the UAE. This would enable Brighter, using its existing technical solution, to store and process the data entered into Actiste® Diabetes Management Solution for users/patients who are based in the UAE.
In June 2021, MoHAP issued the Decision, adding clarity and defining exemptions to the Health Data Law and related legislation. The Health Data Law, subject to any exemptions, prohibits the transfer, storage, generation or processing of health data that relates to health services provided in the UAE outside of the country. The Decision clarifies concepts used in the Health Data Law pertaining to restrictions on the collection, processing and transfer of health data affecting a broad range of entities across the UAE, and creates certain important exemptions, including an exemption relating to the processing of patient data outside the UAE by so-called “simple devices”. There is no formal process stipulated under the Decision at present for official determination as to the applicability of this exemption.
“We are very pleased to receive this very welcome preliminary assessment from the UAE’s Ministry of Health and Prevention that Brighter’s Actiste® device is considered to fall within the “simple device” categorization. The Company is evaluating the implications of this development and will communicate in due course its assessment of how this affects go-to-market prospects under previously announced partnership agreements for the UAE. This is an important commercialization milestone for Brighter and we remain focused on providing services for patients and healthcare providers in the UAE,” commented Christer Trägårdh, Chairman of The Board at Brighter AB.
Next Steps
Brighter remains on track with its commercialization of Actiste® in the UAE. Beyond ongoing evaluation of legal developments concerning the Health Data Law, the next steps in the commercialization process for Actiste® in the UAE include receiving approval for radio transmission and registering Actiste® as a radio transmitting device at the Telecommunications Regulatory Authority (TRA).
For further information, please contact:
Investor Relations
IR@brighter.se
Certified Adviser
Brighter’s Certified Adviser is Eminova Fondkommission AB, +46 (0)8 – 684 211 10, adviser@eminova.se, www.eminova.se.
About Brighter AB (publ)
Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions are designed with a vision to facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones, and their care providers – aiming to improve quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. Brighters kvalitetsledningsystem är ISO-13485-certifierat. In 2019 the company won the Swecare Rising Stars Award. The Company's shares are listed on Nasdaq First North Growth Market/BRIG.
For more information, please visit our website via the following link: https://brighter.se/
This information is information that Brighter AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 20:00