In October 2022, the U.K. Medicines and Health products Regulatory Agency (MHRA) published its Guidance, Software and AI as a Medical Device Change Programme – Roadmap, setting out how it will regulate software and AI medical devices in the U.K. by balancing patient protection and providing certainty to industry.
Background to the Reforms
The MHRA initially announced the Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) Change Programme in September 2021, designed to ensure that regulatory requirements for software and AI are clear and patients are kept safe. This builds on the broader reform of the medical device regulatory framework detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom, which recently saw its timetable for implementation extended by 12 months to July 2024.
Continue reading “Update: AI Regulation in the U.K. — New Government Approach”
Singapore’s Personal Data Protection Commission (PDPC) issued a statement on March 1 announcing its plan to introduce mandatory breach notifications as part of a set of proposed amendments to the country’s Personal Data Protection Act (PDPA). The proposed amendments come in response to the PDPC’s recent review of the PDPA in order “to ensure that it keeps pace with the evolving needs of businesses and individuals, and balances safeguarding individuals’ interests and enables the legitimate use of personal data by organisations.” The details of the mandatory breach notification have not yet been made public, but the amendment will likely require organizations to notify the PDPC and affected data subjects when a certain level of breach has occurred.
Continue reading “Coming Soon to Singapore: Mandatory Data Breach Notifications”
The Information Governance Initiative (IGI) recently released its third annual “State of Information Governance” report . Highlights include a sharp rise in IG projects underway and a shift toward organizations deriving value out of properly stored data. Indeed, nearly twice as many respondents (176percent of prior-year baseline) indicated that they are extracting business value from their information.
While external factors to include data breaches and data privacy regulations largely drive IG projects, there is mounting internal pressure to reduce storage costs, limit exposure to potential data breaches, and consolidate data. IGI found that respondents overwhelmingly agreed that information governance is an essential component of internal and external cybersecurity.
Below are key takeaways from the report, including respondent results and IGI’s analysis and recommendations.
Continue reading “Information Governance Gains Traction, Maturity, and Value Proposition: State of IG Report”
The United States recently became the first country to participate in the new Asia-Pacific Economic Cooperation (“APEC”) Privacy Recognition for Processors (“PRP”) program. Finalized in 2016 and designed to certify privacy compliance for personal information processors within the Asia-Pacific region, the PRP program offers a trustmark certification to processors that demonstrate their capacity to assist data controllers in complying with relevant privacy obligations. According to APEC, the PRP program was created so that (1) data controllers are able to identify qualified data processors to implement data controllers’ data processing obligations, (2) data processors are able to demonstrate their ability to provide effective implementation of a controller’s privacy requirements, and (3) small and medium-sized institutions are able to gain exposure and visibility into a global data processing network. Continue reading “United States Is First Country to Join APEC Privacy Recognition for Processors Program”
Singapore’s Ministry of Health (MOH) recently drafted a new Healthcare Services (HCS) Bill aimed to bridge the gap between the country’s changing healthcare needs and technological advances. According to the MOH, the healthcare landscape in Singapore is undergoing significant changes, including an ageing population, increased chronic disease prevalence, and advancements in medicine and health technologies. The HCS Bill will “better safeguard the safety and well-being of patients, while enabling new and innovative services that benefit patients to be developed, in the changing healthcare environment.”
Currently, healthcare providers in Singapore are licensed and regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was designed to protect patient safety through the licensing of physical healthcare premises. But, brick and mortar locations are quickly becoming a thing of the past as more and more healthcare services are delivered through mobile and online channels. MOH intends to respond to this shift by repealing the PHMCA and replacing it with this new HCS Bill.
Continue reading “Singapore Addresses Confidentiality of Electronic Patient Records in New Healthcare Services Bill”