The FDA launches new guidance surrounding the development of new health-tech
The Food and Drug Administration (FDA) has recently launched several pieces of guidance to support both the development and implementation of innovative healthcare tools and technologies.
Following from the release of the FDA’s Digital Health Action Plan, FDA Commissioner Scott Gottlieb has released a statement highlighting how it will continue to support regulatory authorities on a global scale.
“We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information.
Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.”
Adapting its policies to foster innovation, the FDA will provide increased clarity on its role to support the growth of the digital health industry and support healthcare providers and professionals in the delivery of exceptional patient care and improve decision making across the board.
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“The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” explains Gottlieb.
“However, the FDA will continue to enforce oversight of software programs that are intended to process or analyse medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.”
The second draft guidance, titled Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, outlines the FDA’s stance of the types of software which they consider to no longer be viable medical devices. It will become a significant document for providers who could be utilising outdated technologies and processes, or for the implementation of new applications which are outside of the FDA’s domain, such as mobile technologies, which bring a multitude of benefits to its users.
Through collaborating with health authorities on a global scale through the International Medical Device Regulators Forum (IMDRF), the FDA has additionally released its final guidance, Software as a Medical Device: Clinical Evaluation, establishing the areas in which regulators will need to address in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD) and the potential risks surrounding such technologies.
Skin Analytics wins NHSX award for AI skin cancer tool
An artificial intelligence-driven tool that identifies skin cancers has received an award from NHSX, the NHS England and Department of Health and Social Care's initiative to bring technology into the UK's national health system.
NHSX has granted the Artificial Intelligence in Health and Care Award to DERM, an AI solution that can identify 11 types of skin lesion.
Developed by Skin Analytics, DERM analyses images of skin lesions using algorithms. Within primary care, Skin Analytics will be used as an additional tool to help doctors with their decision making.
In secondary care, it enables AI telehealth hubs to support dermatologists with triage, directing patients to the right next step. This will help speed up diagnosis, and patients with benign skin lesions can be identified earlier, redirecting them away from dermatology departments that are at full capacity due to the COVID-19 backlog.
Cancer Research has called the impact of the pandemic on cancer services "devastating", with a 42% drop in the number of people starting cancer treatment after screening.
DERM is already in use at University Hospitals Birmingham and Mid and South Essex Health & Care Partnership, where it has led to a significant reduction in unnecessary referrals to hospital.
Now NHSX have granted it the Phase 4 AI in Health and Care Award, making DERM available to clinicians across the country. Overall this award makes £140 million available over four years to accelerate the use of artificial intelligence technologies which meet the aims of the NHS Long Term Plan.
Dr Lucy Thomas, Consultant Dermatologist at Chelsea & Westminster Hospital, said: “Skin Analytics’ receipt of this award is great news for the NHS and dermatology departments. It will allow us to gather real-world data to demonstrate the benefits of AI on patient pathways and workforce challenges.
"Like many services, dermatology has severe backlogs due to the COVID-19 pandemic. This award couldn't have come at a better time to aid recovery and give us more time with the patients most in need of our help.”