Devices, Feature, Report, Technology

Easier exchange: Standardisation of ophthalmic imaging

Insight investigates the major challenges of accessing and sharing digital images captured on multiple ophthalmic devices, and whether proprietary interests take precedence over clinical convenience.

The story of how Australia wound up with a network of inconsistent railway gauges, the result of each state establishing its own independent system, with little or no forethought about future inter-connection between states and capital cities, is part of national folklore.

In some respects, ophthalmic imaging equipment has developed in a similar vein, with manufacturers giving little consideration to interoperability.

Experts agree that up until the last 10 to 15 years, technology hasn’t been able to support interoperability like it can today, so the demand for standardised image formatting wasn’t front-of-mind.

But that began to change when Digital Imaging and Communications in Medicine (DICOM) standards – for the communication and management of medical imaging information – gathered momentum in the early 2000s.

Earlier this year, RANZCO endorsed a recommendation by the American Academy of Ophthalmology (AAO), the world’s largest ophthalmic association, urging manufacturers to implement the DICOM standard to facilitate an easier exchange of digital imaging data.

Mr Anton Pretorius and Mr Walter Palomino, senior software engineers at Topcon Healthcare ANZ, say discussion about standardisation in the ophthalmic device market has been on the table since at least 2011.

Walter Palomino
Walter Palomino, Topcon Healthcare ANZ

“The lack of compliance can be attributed to a combination of three key factors: lack of demand from industry end users; lack of enforcement by peak bodies; and a lack of desire to cooperate from companies who have business models that have historically been built around directing customers towards specific products, while offering only a basic level of functionality with other manufacturer’s devices,” they said.

“As cloud-based storage has become more common, secure, and affordable, the full potential of its application to clinical care – including research – has become evident. With that, the shortcomings of the current lack of standardisation have become increasingly apparent.”

Consensus on challenges of siloed data

Pretorius and Palomino are familiar with the major challenges modern eyecare practices face in terms of sharing, compiling, and accessing images captured on multiple ophthalmic devices.

“Perhaps the most important challenge is the ability to view and analyse the raw data that is being captured on these devices when the images and reports they produce are delivered in different formats and require specific applications for them to be useful,” they say.

This, they add, has a direct impact on a clinician’s ability to provide efficient patient care.

“The biggest impact is felt by the patient because their data is siloed by disparate sources, disconnected clinical systems, and the subsequent need for manual processes to review and assess data. The impact of disconnected clinical systems is felt again when this data needs to be moved offsite for a second opinion or referral to secondary care,” Pretorius and Palomino say.

Anton Pretorius
Anton Pretorius, Topcon Healthcare ANZ.

Clinicians and staff are forced to revert to manual processes that are slower, more expensive and more resource intensive. It requires the duplication of patient data in soft and/or hard copy for different applications, which can result in a decline in the quality and usefulness of an image through lost resolution.

“It also creates additional costs to the business in the form of staff time to service the manual processes required to plug holes where technology falls short, as well as the cost in creating the resources themselves. The flow-on effect on the patient is care that is slow and inefficient,” Pretorius and Palomino say.

The challenges they describe are daily setbacks ophthalmologists know only too well.

RANZCO ophthalmic surgeon and CEO of Melbourne-based medical technology manufacturer Nebula Health Dr Chandrashan Perera says they leave room for human error.

“Each device comes with its own proprietary software, as such you need multiple programs open and switch between them with the risk of opening the wrong patient’s file,” Perera says. “We need to become accustomed to using multiple different pieces of software, then continually learn the updates. We manually need to transcribe the results from the machines into the patient’s electronic medical record, which is a potential transcription error.”

He agrees that the result of incompatible technology can be measured in time and cost.

“Patients often end up with multiple unnecessary repeated tests. If a patient has had a recent scan at an optometrist before referral, and we were able to use those scans as a baseline for future scans, then it would be unnecessary to scan the patient again at the clinic. However, at the moment, if the patient requires ongoing follow-up, then I am obliged to take another scan so that I have a baseline scan that my machine can compare against for future reference,” Perera says.

“If a patient is transferred to another practice, you lose the ability for the machines to be able to calculate long-term trends, and instead the data is treated as two separate chunks of data.”

This is vital for tests like visual fields. Perera says the loss of longitudinal information when shifting providers risks worse outcomes.

But the negative impact of incompatible technology is not only limited to patients and practitioners. Medical research is hampered immensely, he says.

“All this device data represents a great opportunity for medical research to be able to improve the quality of care given to patients, facilitate clinical trials and develop new therapeutics. Today, getting access to this data in a manner that is conducive to research is extraordinarily expensive and manual, purely because many devices don’t provide machine-readable data that can be then analysed at scale.”

Mr Renato Antolovich, retina and glaucoma marketing manager for Zeiss Medical Technology ANZ, says the transmission of image and other patient data needs to be performed securely and reliably, to meet patient data privacy obligations and sufficient access to data for clinicians – at the same time.

“Standardisation of file format and transmission protocols for medical data is a prerequisite to enable this, so clinicians have access to the full data set and are best supported to provide optimal clinical care,” Antolovich says. “The better the data exchange works – enabled by a sufficient level of interoperability – the better the collaboration amongst involved clinicians becomes, leading to higher efficiency and improved quality of patient care.”

Impetus for standardisation

In the absence of interoperability, Perera says ophthalmologists rely on manual processes to extract data.

“Some vendors provide software that works only with their software – thus tying you into one device vendor. Other vendors that provide multi-device support are limited by the type of data they can access from certain vendors,” he says.

Dr Chandrashan Perera.

How did we reach this point? He believes the answer lies in a combination of a lack of demand, together with potential commercial issues.

“It has been noted in many areas of health, devices tend to limit interoperability. Partially this is due to increased technical requirements from the vendor, but also results from vendors trying to improve their competitive position. We have seen however in other specialties such as radiology where open standards have the potential to help both vendors and care providers,” he says.

Pretorius and Palomino agree the DICOM protocol presents the most straight-forward pathway to achieving efficient sharing of patient data in eyecare.

They say that, applied properly, it would enable the seamless transfer of patient data between different sites and deliver uniformity to how patient data is assessed and used, regardless of the hardware and software available at different sites.

Dr Ben Ashby, director of optometry for Specsavers ANZ, shares the same thinking. The optical franchise supports an industry-wide move towards standardisation in digital imaging.

“We have been investing in standardisation across all our Australian and New Zealand practices for some years now. This includes DICOM-compliant OCTs in every practice. As a result, more than four million patient examinations every year include digital images and OCT that meet these standards,” Ashby says.

“We strongly believe in the value of standardisation to provide the best collaborative care with ophthalmology. Agreeing on image sharing protocols will not only improve efficiencies within the health sector, but it will lead to better co-management and improved patient outcomes, which is always the driving force underpinning any clinical or digital transformation.”

But it could be a long road ahead, with some manufacturers still choosing to encrypt clinical data, Pretorius and Palomino say.

“This can result in all-in lock-in situations that dictate device and software selection for a clinical business. This means that clinics and sites who do not use the same devices and software end up with a static data set and are unable to manipulate the raw data, scroll through data slices or interact with the imaging in any way, thereby necessitating the need for a second set of scans.

“These tactics are typically employed by manufacturers to ensure long-term financial commitment from customers. Now that technology can deliver the ability to share patient data virtually and securely between locations, expectations of clinicians and patients is driving demand away from siloed clinical business systems towards open source, standardised data.”

Expectations are one thing; reality is another. As Pretorius and Palomino explain, the main challenge to vendor-neutral connectivity is how each different device encrypts patient data.

With hundreds of devices on the market, having the functionality that allows not only simultaneous viewing, but also manipulation of raw data is the biggest technical challenge.

“Images or scans need to be compatible to an extent that enables uniform core viewing requirements when using a single platform, such as Topcon Harmony,” they say. “Data management platforms, such as Harmony, do more than simply facilitate simultaneous viewing of images and live data manipulation – they give clinicians a comprehensive data management solution which delivers benefits to a clinical business that far outweigh what DICOM could deliver in and of itself.”

Antolovich from Zeiss says there’s no doubt that DICOM is a must. DICOM has been widely adopted in medicine, with radiology as the pioneer. Ophthalmology started in the early 2000s with an initiative of the AAO to make use of a range of industry standards such as HL7 and DICOM.

Renato Antolovich
Renato Antolovich, Zeiss ANZ.

“Zeiss has been an active participant in this space for the last 15 years driving standardisation and interoperability. As a result, all Zeiss devices of the latest generation come with a DICOM interface,” he says.

“It’s important to note that when innovations come to the market, standards may not yet exist and must be developed. Also, established standards need continuous updates during the maturation process of the technology so that the standard continues to represent the full functionality possible. Thus, standardisation and interoperability are a constant effort. Zeiss regards interoperability and data standardisation as an enabler for the advancement of medical care and is therefore further contributing to this work.”

‘It’s a problem we need to overcome’

The concept of DICOM compatibility and associated sharing of digital imaging is a subject Mr Michael Yapp has been working on for many years as part of Centre for Eye Health’s (CFEH) collaborative care programs.

Yapp is a qualified and therapeutically-endorsed optometrist, and while not an expert in DICOM standards, in his role as head of clinical operations at CFEH in Sydney he has been involved in working with multiple imaging devices from various distributors as well as contributing to publications in trade magazines on this topic.

Michael Yapp
Michael Yapp, Centre for Eye Health.

“[The] Centre for Eye Health is an intermediary care facility, bridging between optometry and ophthalmology. Under a collaborative care model, we share patient care with Westmead and Prince of Wales Hospitals as well as community optometrists and ophthalmologists, so it’s important to have the ability to share imaging to assist with both diagnosis and management,” he says.

Yapp says while DICOM standards have been around for a long time, compliance varies as most ophthalmic devices conform to DICOM in different ways.

“One major benefit of the standards is being able to view multiple instruments and different models of the same type of instruments in the same platforms. This helps in analysing all the data for a specific visit but, in particular, assists in the ability to perform change analysis – measuring change and making direct comparisons over a period to make more informed judgements,” he says.

Yapp says part of the problem is overcoming issues with file sizes and rules around data privacy.

“It’s a problem we need to overcome because clinicians can offer a much better standard of collaborative care if they can perform change analysis, and that would benefit greatly from different data sources being compatible.

“For example, a patient with macular degeneration may have an OCT scan to establish how much fluid is leaking into the macula, using a protocol incorporating 61-line scans. Three months later, another scan on the same machine will show if the leaking has gotten better or worse. But if the scan is done on a different machine in a physically different location, the clinician won’t be able to accurately demonstrate change analysis because they won’t be able to make a direct comparison of the two scans.”

Yapp says an increase in collaborative care is driving the need for open access to data.

“Is standard of care compromised without universal access to patient data? That’s putting it too strongly, but it limits clinicians’ ability to provide effective collaborative care,” Yapp says.

Melbourne firm Cylite, which has innovated the Hyperparallel OCT, notes that the DICOM standard is incredibly complex, and comes with multiple challenges.

When designing its own device, the company chose to make its Cylite Focus software a common platform, and is planning to provide linkages to practice management systems and to support DICOM.

“Our guiding principle is the acquired data belongs to the user and not us. We will do all we can to give our users access to the data they need to manage their patients and advance research.”

However, the company notes that the DICOM standard does not always support natively all instrument-specific data types (Information Object Definition) that instruments produce, for example corneal topography, biometry data, perimetry.

Even if the standard does support the data format, the DICOM PACS/viewing platform being used must also support these IODs and often they do not support those from specialty areas outside of radiology.

“Standards like DICOM tend to reduce things to the lowest common denominator. If your instrument has extended functionality that other instruments do not support, then it probably won’t be supported in the standard,” the company stated.

“Integrating older instruments can also pose challenges – most newer instruments at least output a useable electronic file and many use DICOM but there’s sometimes nothing that you can do if an instrument doesn’t have an ethernet port for example.”

Where to from here?

For Pretorius and Palomino, the future prevalence and evolution of digital and cloud-based solutions in clinical practice will be driven by three key factors.

Firstly, the sheer volume of patient data passing through clinical practices and the need for systems that will allow for effective management and security.

Secondly, seamless access to technology, like AI and machine learning, to support clinical decision making and diagnosis as demand on clinical time increases.

And thirdly, consumer choice – specifically, the ability to meet the real needs of the consumer and customise solutions that respond directly to the business needs and preferences.

“Data management platforms like Topcon Harmony are addressing one of the biggest challenges facing the eyecare sector – access to data. As platforms like Harmony start to become the norm in clinical businesses, expectations of what they can deliver will also grow. What we understand to be comprehensive data management today will evolve to continue meeting changing user needs, as well as in response to potential that is unlocked by technology,” Pretorius and Palomino say.

Perera is a proponent of widespread adoption of imaging standards, including DICOM and the Fast Healthcare Interoperability Resource (FHIR, pronounced “fire”). FHIR is a standard describing data formats and an application programming interface for exchanging electronic health records.

“Formalised standards are ideal, but even having files which contain the required information, together with documentation from the manufacturer as to how third-party vendors can access that data without having to rely on any manufacturer-specific software would be a great starting point,” he says.

“Ultimately however, the industry is moving towards utilisation of DICOM standards, which allows far more standardisation across the different devices and manufacturers – allowing for data to be accessed far more readily.”

How this area of eyecare will play out remains to be seen but Perera suspects there will be a slow transition period from device manufacturers given the technical challenges to overcome and initial reticence to give up a potential competitive edge through vendor lock-ins.

“Ophthalmologists are starting to understand the benefits of interoperability in their own clinical context, such as the ability to switch to the best device available on the market without having to discard their old data. Furthermore, peak body groups such as the American Academy of Ophthalmology are also helping to push the demand for interoperability,” Perera says.

“As the demand for devices with interoperability grows, device manufacturers that offer interoperability are likely to see increased commercial interest in the purchase of their devices.”

Antolovich from Zeiss confirms the growing market demand for interoperability: “The conversations we have with our customers are going beyond the product’s capabilities to share and exchange data.

“This is the reason why we further concentrate on interoperability and extend our software solution – which is currently Zeiss Forum – in the direction of a cloud module, so that customers can take advantage of the technology and achieve more efficient and higher levels of patient care.”

Ultimately, Yapp predicts that because propriety interests will not abate, and imaging technology is a competitive space, manufacturers will continue to invest in and develop software platforms that can provide access to scans and images from multiple devices, such as Topcon Harmony, Pliny, and Zeiss Forum.