A whole section comprising seven questions was given to the subject of delivery of remote care and technology in the General Optical Council’s call for evidence on the Opticians Act and consultation on policy, so it was clear the regulator is taking the topic seriously. But is it too little too late?
The Association of Optometrists (AOP) said there were indeed gaps in regulation and GOC policy when it came to regulation of technology and remote care that present risks to patients, expressing concern that the GOC had not evolved its regulatory approach to meet future challenges. ‘Regulatory oversight needs to adapt to maintain public protection,’ said the AOP in its response.
‘Appropriate regulatory mechanisms should be used to manage the risks that arise from new technologies, such as AI and remote care,’ said the AOP. ‘This includes standards for individuals and businesses, including GOC regulatory action where care is being delivered in novel ways that pose risks to patients.’
The Association for British Dispensing Opticians (ABDO) echoed the AOP’s sentiment by stating the GOC needed more power to regulate new technology and, more importantly, the providers. ‘The Opticians Act has not prevented the rollout of technologies to enhance patient care and the UK model of primary eye care has encouraged and enabled this innovation. However, the need to ensure that technology is used safely in practice strengthens the case for a consistent and comprehensive approach to business regulation.’
Several areas of risk were identified by the AOP, including changing consumer behaviour leading to patients attending less frequently for sight tests, no checks on recent sight tests and fitting when purchasing contact lenses online and a lack of checks on the age of buyers, resulting in risk from undetected conditions such as amblyopia.
Overseas threat
In its response, the AOP went on to highlight the emerging threat from overseas providers of remote eye care services. ‘The main risks here are that overseas providers could operate in ways that are not in accordance with UK optical regulations – using non-GOC registered professionals who are poorly trained, use tests that lack validity and do not understand the issues that apply in UK healthcare,’ noted the AOP.
The AOP said it had made several suggestions to the GOC in recent years as to how it could improve its regulatory approach when it came to online supply. Despite minor improvements, the AOP said: ‘There is still much more that the GOC needs to do in order to protect patients from risks of harm.’ Much of the AOP’s advice involved working with the suppliers or providers that were operating outside of UK law and educating the members of the sector and the public. The AOP urged the GOC to consider whether additional legislative powers would be needed in order to manage patient risk more effectively.
Remote care across the pond
After years of discussion with the United States Food and Drug Administration (FDA), Visibly has received 510(k) clearance for its online digital refraction platform, the Visibly Digital Acuity Product (VDAP).
A 510(k) is the technical dossier required by the FDA to sell a medium-risk medical device and contains pertinent technical, safety and performance information. The documentation must demonstrate the device in question is ‘substantially equivalent’ to a predicate device already cleared for sale in the US.
In submitting the test for FDA clearance, Visibly performed a multicentre clinical study comparing it to the current standard for visual acuity exams in the US, called the chart-based Early Treatment Diabetic Retinopathy Study.
According to the company’s chief operating officer, Paul Foley, the study ‘demonstrated that the safety and effectiveness of VDAP are substantially equivalent to those of its predicate device.’
Visibly said it was eager to accelerate its mission to partner with the leading optical organisations to equip eye care professionals and their patients with a convenient and affordable way to get information about how well people were seeing from their own homes.