Standardised telemedicine for disease management
It took some time, but at the end of October 2017, Austria finally published its national guidelines for telemonitoring. Mobile care scenarios for diabetes, heart failure and follow-up care of patients with implants are said to be the first use cases and might leverage remote medical data surveillance, and thus patient safety.
However, before these programmes can be brought effectively into practice, all relevant standards organisations have been given the chance for comment in order to future-proof the interoperability guidelines. Only then, will the Austrian Federal Ministry of Health finalise and publish these. So far, legal validity is still pending, and the Ministry’s representatives did not provide Insights with any statement on the progress nor a final publishing deadline.
“What we have today in many parts of Europe is a proliferation of telemonitoring programmes that each use their own specifications or proprietary platforms. The result is an incredible fragmentation in the market, which inhibits scale and effectiveness,“ states Michael Strübin, EU Programme Director at the Personal Connected Health Alliance (PCHAlliance), one of several organisations that make relevant standards for such programmes, along with Integrating the Healthcare Enterprise (IHE). Sharing an objective to build an interoperable ecosystem for open health information exchange, both organisations with their complementary work ensure that personal health device data flow into electronic health record systems like Austria’s ELGA, with data formatted and coded correctly at the source: the patient.
However, while IHE profiles primarily cover data and information exchange in clinical care delivery settings, PCHAlliance’s Continua Design Guidelines (CDG) focus on the patient and define standards for the interface between personal health devices and the healthcare enterprise, namely GPs, hospitals or health services. Connecting patient devices to healthcare services is a critical part of home monitoring systems and mHealth applications, which have the potential to empower the patient with information and move care from the hospital to the home. “We do conformity tests and certify if personal health devices comply with our Continua Guidelines, which are based on international standards and open specifications,” Strübin explains.
Private clouds vs Public health system
The scope of these devices range from medical wearables such as the glucometer for a diabetic patient to blood pressure and heart rate monitors, weight scales and activity trackers. “Currently the most widespread business model for device companies, especially those in the consumer market, is to bind their customers to their company. Instead of transferring their data to open standards that can link to the healthcare system, they build walled gardens with smart and shiny devices, beautiful and user friendly interfaces and features, and private clouds,“ Strübin says. The challenge is that data remains locked in private silos, inaccessible for the purpose of diagnostics, therapy, scientific research, data analytics, or public health.
CDG: Harmonising standards
This might change for the better once the Austrian reference architecture is officially installed. “We welcome the draft as it relies to a large extent on our Continua Design Guidelines,“ Strübin asserts.
He goes on to say: “Also, PCHAlliance and IHE co-ordinate their work closely at the personal health device interface where they overlap.“ So, once the data has left health, medical and fitness devices and flows via a personal health gateway, usually a hub, smartphone or tablet, to the health information services (HIS), eventually streaming into the health information exchange. CDG and IHE profiles, on which ELGA is based, are complementary.
Beyond the synergy between IHE and CDG, the HL7 FIRE standard is also part of the discussion. “The relatively new HL7 FHIR specifications have become popular for the transfer of data from mHealth applications to electronic health systems, and have attracted a following among app developers who like their ease of use,“ states Strübin. As a consequence, the newest version of the Continua Guidelines released in December 2017 include HL7 FHIR specifications for data upload, enabling an easier integration of Continua-certified devices into electronic health record systems.
Broadening the perspective, there seems to be a movement within European governments to encourage this interoperability.
Still, for PCHAlliance an important priority is to grow the number of Continua-certified and –compliant devices on the market. PCHAlliance members, like all companies, respond to market signals, and so far the challenge has been a lack of demand. “Health providers and systems have not requested connectivity so far. That is why we consider the Austrian national guidelines a promising step for future interoperability," Strübin concludes. There is a clear commitment from the Austrian health system, agreed with payers and providers, to build large-scale telehealth services. This will present a compelling business case, and an incentive for device makers, to bring standards-compliant products to market.
EU pioneers of standardised telemedicine
Broadening the perspective, there seems to be a movement within European governments to encourage this interoperability. The Austrian government project is not the only IT architecture of its kind in Europe on a national level. Other healthcare systems such as Catalonia, Denmark, Finland and the Netherlands, similarly let patients upload their data via open standards. In July 2017 the Catalan Health Ministry mandated Continua compliance for glucose meters, and worked with several makers of blood glucose meters to assess and confirm compliance with the CDG.
“The CDGs have sometimes been criticised as being too complicated or burdensome to implement,“ open standards advocate Strübin points out. “But the Catalan initiative shows that when a government mandates compliance with open standards, then device manufacturers will follow, and they can adapt their devices within a few weeks.“
In Finland data is currently derived via HL7 FHIR and in the Netherlands a project called “MedMij” is about to review the standards. In Denmark, hundreds of telemonitoring pilots of all types have been gathered up to be merged and integrated via open standards. The idea and lastly the benefit of this standardised telemedicine is to be able to join devices from different manufacturers with only a little effort. Counter samples are proprietary models such as NHS Scotland’s programme ”my diabetes my way“ that contracts with Glooko/Diasend to plug in blood sugar measuring devices. Likewise the US-company VALIDIC has collected hundreds of personal health devices to sell tailor-made interface at high price.
With that in mind, it seems all the more important that other European health systems follow Austria’s example and have the guts to not only recommend open standards, but prescribe them. Obviously, IHE and the currently emerging IHE records are not sufficient alone to integrate mobile devices. Namely with CDG that can be realised and that is, from a European perspective, considerably better than leaving the field to Apple and Google alone. So far, the latter have also not been engaged with PCHAlliance and will, as experts say, not move unless demand has significantly increased. That is why the challenge remains to invite mobile device manufacturers to not only pay lip service, but to actually implement the Continua guidelines either via a gentle national push or at least through big projects with specified tenders.