Mobile technology has become an integral part of everyday life, with the vast majority of people owning smartphones, tablets, or both. It has changed the way life is lived, even the way people receive health care. According to health data analytics company IQVIA, some 318,000 mobile health (mHealth) apps are available in major app stores, with another 200 being added every day. More importantly, IQVIA noted that over 60% of people have downloaded a mobile medical app.1 At the same time, the healthcare industry has become more decentralized as hospital networks build and acquire more locations to reach more potential patients where they are.
The conjunction of these two trends is forcing health care providers and providers to change the way they deliver care. For radiology, this means providing anywhere, anytime access to medical images for radiologists, referring providers and patients. Mobile visualization apps allow smart devices to become a gateway to imaging archives, and with more vendors offering these tools, vendors are scrambling to figure out how best to integrate them into their workflow. day-to-day.
The FDA and Medical Mobile Apps
The majority of medical technologies must be approved by the United States Food and Drug Administration (FDA) before they can be sold for clinical use in the United States. Unlike more traditional technologies such as imaging systems and processing software, mobile applications require a more nuanced approach. approach.
The FDA approved the first diagnostic radiology app, Mobile MIM, in 2011, but it didn’t release comprehensive guidance on medical mobile apps until 2013. Recognizing the varied nature of mobile apps, the FDA chose to take an “approach” to regulation. The agency only regulates apps that 1) could impact patient safety, such as radiation dose calculators, or 2) turn a mobile device into a regulated medical device, such as access software that requires a 510(k) approval. The remaining category of unregulated medical mobile apps include those for patient education, fitness tracking, and clinical reference and/or training apps.
Achieve diagnostic quality with mobile
Perhaps the biggest question regarding the adoption of mobile devices in radiology is whether they provide enough resolution to enable diagnostic-quality visualization. Mobile MIM’s approval in 2011 was a milestone, as prior to that, mobile was widely seen as suitable only for secondary reading or consultations.
Numerous studies have backed up this conclusion, including a pair of papers published in 2012. A Singapore study highlighted the potential use of iPads for emergency radiology teleconsultations, showing less than 6% discrepancies between the interpretation of the iPad and the results obtained on a PACS workstation.2 A second study from the University of Sydney compared the diagnostic effectiveness of iPads with LCD secondary display monitors in identifying lung nodules in chest X-rays, finding no significant difference between the two.3
More recent research suggests the technology has improved and may be suitable for diagnostic reading. A 2019 Journal of the American College of Radiology study examined the accuracy equivalence of CT scan interpretations of the head in acute stroke patients using a smartphone, laptop or PACS workstation. The PACS station used Agfa Healthcare’s Impax 6.5 viewing software, while the laptop and smartphone readers used Agfa Xero Viewer 3.0. The retrospective study asked four neuroradiologists to do 2,256 interpretations of 188 stroke patients. Accuracy equivalence has been tested for:
• Detection of imaging contraindications for IV administration of recombinant tPA (eg, hemorrhagic lesions);
• Ischemic lesions;
• Hyperdense arteries; and
• Acute ischemic injuries.
The research team evaluated sensitivity, specificity, and receiver operating characteristic (ROC) curves for each interpretation. The curves indicated similar reading performance on all three systems, and the researchers noted that there was no more than 30 seconds of difference between the reading time of the mobile devices and that of the medical workstation.4
“We’re offering mobile as an alternate viewing medium, not the primary one,” said Mark Filiault, chief information officer of Connecticut Orthopedic Specialists (COS). “You want to examine diagnostic quality on a diagnostic quality monitor.”
Mobile app technology in practice
Connecticut Orthopedic Specialists is one of the largest orthopedic groups in the state, comprising 64 orthopedic specialists in five practices. The group has 21 locations across the state, including two state-of-the-art MRI centers. According to Connecticut Orthopedic Specialists CIO Mark Filiault, the total imaging inventory includes three magnetic resonance imaging (MRI) systems and 24 x-ray rooms, as well as ultrasound and additional fluoroscopy. Filiault added that two of the three MRI scanners are based in the office, while the third moves between two locations.
“We needed a common database for our DICOM and non-DICOM image inventory,” he said. CT Ortho went fully online with the Ambra Health image cloud in the fall of 2017, and Filiault said there are now over a million medical images stored on the central server.
When a doctor requests an image or a set of images from his mobile device, the central server is commandeered and a copy of the data is sent to the requesting device via a local server. Filiault said the image copies reside on the local server for 48 hours before being erased to protect private health information (PHI).
COS takes a combined approach to mobile devices – it provides “trusted devices” at its various locations, but also allows physicians to bring their own devices (BYOD). Filiault said access to medical records and other sensitive information is restricted on private devices and enabled on trusted devices. The Ambra app can be used on private devices, he said.
Other vendors offering radiology viewing apps include:
• Novarad: Novarad received FDA approval for the MobileRad application in 2016, which integrates with NovaPACS to display data on a third-party mobile device. The company also offers the SnapView app, which allows clinicians to securely collect non-DICOM images from departments such as wound care, emergency departments, ophthalmology and dermatology. Images are transferred directly to the Novarad archive from iOS, Android and Windows mobile devices, with no PHI left on the device.
• Candelis: Candelis achieved approval for the Astra Mobile application as part of its Astra software services in 2011. Astra Mobile enables users to receive, view, download and print medical reports and key images anywhere in the world .
• Carestream: Carestream’s Vue Motion Universal Viewer received FDA approval for use on mobile devices in 2011. The clearance was expanded to allow access from multiple operating systems and via a web browser with operating platforms using HTML5, including validated PCs, Macs and mobile devices.
• GE Healthcare: GE offers mobile viewing from its Centricity PACS, Centricity Enterprise Archive and Advantage Workstation servers through the Centricity Radiology Mobile Access application.
The future of mobile in radiology
Like any technology, new applications will continue to emerge for mobile devices in viewing medical images.
Connecticut Orthopedic Specialists (COS) is currently working on two pilot projects to expand its use of mobile technology with providers and patients. In one instance, Filiault said her doctors brought iPads into the exam room to show patients their images during appointments. “It’s more of a visual aid and a courtesy to the patient,” he said. This year, COS also began offering a radiology patient portal where patients can access and upload their own images. Filiault said this has dramatically reduced the number of CDs burned to move images from one provider to another through the patient.
1. The growing value of digital health: evidence and impact on human health and the health system. IQVIA, November 7, 2017. https://www.iqvia.com/institute/reports/the-rating-value-of-digital-health
2. John S., Poh ACC, Lim TCC, et al. The iPad tablet computer for on-call radiological diagnosis? Audit discrepancy in CT and MRI reports. Journal of Digital Imaging, published online May 5, 2012. doi: 10.1007/s10278-012-9485-3
3. McEntee MF, Lowe J., Butler ML, et al. iPads and LCDs show similar performance in detecting lung nodules. Proceedings Volume 8318, Medical Imaging 2012: Image Perception, Observer Performance and Technology Evaluation; 83180C (2012) https://doi.org/10.1117/12.913754
4. Salazar AJ, Useche N., Bermúdez S., et al. Assessing the accuracy equivalence of head CT interpretations in acute stroke patients using a smartphone, laptop, or medical workstation. JACR, published online May 6, 2019. https://doi.org/10.1016/j.jacr.2019.04.001