Embracing change in a

Embracing change in a digital landscape

2020 Peter Barry Memorial Lecture discusses evolution of healthcare in the post COVID-19 world. Dermot McGrath reports

The COVID-19 pandemic has had a profound impact on the delivery of ophthalmic care over the past year, accelerating the use of telemedicine, artificial intelligence and digital health applications as ophthalmologists try to adjust to the new normal, said Malvina Eydelman MD in her 2020 Peter Barry Memorial Lecture.

Dr Eydelman MD, Director of the Office for Ophthalmic, ENT, Anesthesia, Respiratory and Dental Devices, Food and Drug Administration in the United States, told her online audience that there would be no return to the status quo before COVID-19.

“Shortly after the start of pandemic, it became clear that we were not returning to pre-COVID norms and that we would now have to develop the process of providing patient care in a new normal. Of great concern was U.S. Centers for Disease Control and prevention’s (CDC) finding that an estimated 41% of adults in the United States had delayed or avoided medical care, including urgent or emergency care, due to COVID concerns. It was becoming rapidly clear that healthcare systems and regulatory bodies around the world had to rapidly adopt new ways to take care of our patients,” she said.

In April 2020, an American Academy of Ophthalmology Survey found that 81% of ophthalmologists were at just 0-10% of pre-COVID clinical volumes and 96% were at 0-10% of pre-COVID surgical volumes. Furthermore, most ophthalmologists said that telemedicine was not a significant help at this stage of the pandemic and nearly 90% applied for federal grants and loans to cushion the financial impact of the reduced patient volumes, said Dr Eydelman.

To respond to the crisis, the FDA’s Center for Devices and Radiological Health (CDRH) took unprecedented measures in terms of volume, speed and agility, spanning multiple areas such as regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployments and extensive engagement with numerous stakeholders.

One example of CDRH policy to help expedite access to devices, was the guidance for remote ophthalmic assessment. In this guidance, FDA stated that it does not intend to object to the marketing of visual acuity charts, visual field devices, and generaluse ophthalmic cameras without prior submission of a premarket notification where such submission is otherwise required, as long as the device does not create an undue risk in light of the public health emergency.

“The increased regulatory flexibility enabled ophthalmologists to monitor and assess patients remotely during the pandemic.” she said.

Dr Eydelman noted that governments around the world have also taken steps to facilitate the rapid upscaling of telehealth. As a result, there has been a surge in the number of beneficiaries getting telemedicine services. A recent study from Johns Hopkins University found that while telemedicine adoption in ophthalmology was disproportionately lower than other surgical departments, the COVID-19 crisis accelerated the ophthalmic move to digital health applications.

“In some ways we were very fortunate that the pandemic waited to hit us in 2020, as the past decade has allowed the development of a magnitude of digital tools that can be used to remediate the COVID-19 outbreak,” she said.

These digital health technologies include wearable devices, software solutions and healthcare analytics, among others, which have enabled a shift in healthcare from the clinic to the patient, said Dr Eydelman.

Consistent regulatory strategies and policies are needed to expedite access to all aspects of digital technologies, especially given the unique features of software as a medical device (SaMD) that extend beyond traditional medical devices or hardware and include artificial intelligence and machine learning applications, said Dr Eydelman.

In this respect, she highlighted the important role played by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world, who have come together to accelerate international medical device and regulatory harmonisation and convergence.

FDA adopted IMDRF’s recommendations for SaMD and have added these to a number of guidance that FDA has issued in the last 7 years to provide clarity on the FDA’s regulation of digital health products.

To address the unique challenges presented by digital health and ophthalmology, FDA in partnership with five ophthalmic professional organisations and Stanford University, held Ophthalmic Digital Health Workshop in 2017. Soon after, the FDA approved IDx-DR as the first artificial intelligence device to perform diagnosis of diabetic retinopathy without physician input.

Since 2018, ophthalmic AI has become mainstream. The pandemic has turned into a gateway for AI adoption in health care. However, it brings both opportunity and risk. Dr Eydelman stressed the importance of protecting public health and avoiding any unintended consequences to patients from the accelerated uptake of digital health applications. To that end, she said that collaborative communities such as the recently formed Collaborative Community on Ophthalmic Imaging (CCOI) can help to clarify challenges, best practices, strategies and standards while advancing responsible innovation worldwide.

Summing up, Dr Eydelman said that the COVID-19 pandemic represents a unique opportunity for ophthalmology to embrace the digital health revolution.

“The American Medical Association predicts a $250 billion per year utilisation of digital health going forward. This would mean 20% of all emergency room visits could be avoided, 24% of healthcare office visits and outpatient volume could be delivered virtually and 35% of regular home health attendant services could be virtualised. It also opens the door beyond telehealth to drive growth in new markets and populations and scale other applications,” she said.

Hosted every year by the Royal Victoria Eye and Ear Hospital, Dublin, the Peter Barry Memorial Lecture was established to honour the memory of Dr Barry, a founding member and past president of the ESCRS, who passed away in 2016. Malvina Eydelman: malvina.eydelman@fda.hhs.gov