Healthcare systems around the world are entering a new era in which digital healthcare applications are increasingly becoming part of standard medical care. Whereas medications must undergo a strict regulated process of testing before they are approved and eventually reimbursed, a similar process for digital health apps has only recently started to emerge. Some countries are pushing ahead now with digital HTA. They could become trailblazers.
The consumerisation of healthcare has increased the development of apps in the healthcare space exponentially. According to the IQVIA Institute for Human Data Science’s 2017 publication The Growing Value of Digital Health, more than 200 health apps are being added daily to the top app stores globally, with over 318,000 health apps available in 2017 alone. These apps address a wide array of health issues geared to prevent, manage, or treat a medical disease or disorder.
The need for a framework to assess health apps
With the number of available healthcare apps on the rise, so are concerns about their effectiveness and safety. What is the evidence that they do what they claim to do and are there any side-effects associated with their use? Given the rigorous assessment pharmaceuticals and medical devices must undergo to be licensed there is an increasing call to apply the same rigour when it comes to mobile health apps to ensure the adoption of state-of-the-art-technology into healthcare.
HTA coins the attempt to establish such a systematic evaluation of the properties, effects and impacts of health technology. It looks at the safety of an app, how securely it handles data, its clinical effectiveness and usability and considers legal aspects, among others.
The health app trailblazers
A few countries are pushing ahead with HTA on a national basis, with the UK being the first to have published a catalogue of assessment criteria, Germany taking the lead in integrating health applications into standard care and Finland currently working on a national HTA framework. Although Israeli health institutions are using health apps extensively to improve customer service, there is no set of nationally agreed criteria for health app assessment in place.
The UK: Marshalling appraisal of apps
The UK has been a role model when it comes to assessing health apps in Europe. NHS Digital, the national information and technology partner to the health and social care system, has defined a set of criteria that apps must be fulfil to be listed in a catalogue, the so-called ‘NHS Apps Library’. The latter was set up in April 2017 and currently includes 92 apps.
“All apps in the NHS Apps Library are rigorously tested and assessed to ensure they are clinically effective, safe to use, secure and protect patient data, to a recognized national standard. As there are a wealth of healthcare apps in the current market, the Library is available for health professionals and patients to have a resource of trusted, high-quality apps that they can choose from to support them in meeting their clinical needs. We support developers to have their apps accepted into the Library with guidance and feedback and encourage them to submit their apps for assessment,” says an unnamed NHS Digital spokesperson.
To establish what this assessment process entails, NHS Digital has published the guidance for health app developers, commissioners and assessors. A core part of the evaluation are the ‘Digital Assessment Questions’ (DAQ), a set of criteria that serve as a national standard that NHS Digital published in February 2017. “While it references other frameworks, legislation and best practice where appropriate, it is a unique set of assessment criteria that app developers must evidence adherence to in order to be included on the NHS Apps Library”, states NHS Digital upon request.
In the evaluation process NHS Digital examines, “whether apps are clinically effective, safe and easy to use, interoperable with current NHS infrastructure, if appropriate, and hold a high standard of data security,” explains the press team from NHS Digital. The actual reimbursement is not something NHS Digital gets involved in, “this choice is down to the developer,” says one of its press officers and adds: “The NHS would not usually reimburse patients for choosing a paid-for app.”
Once an app is successfully appraised, it becomes part of the NHS App Library. It will remain in the Library indefinitely unless the developer asks for its removal or in the case a developer does not make the required changes to remain in line with current legislation, says NHS Digital.
Germany thrives to integrate apps swiftly into standard healthcare delivery
Although Germany has lagged behind digitising its healthcare delivery, the ‘Digital Healthcare Act’ (Digitales-Versorgungs-Gesetz), a law that came into force in January 2020, marks a turning point. Amongt other innovations, it enables doctors to prescribe digital health applications (DiGAs) for the first time. The costs are to be covered by the statutory health insurance companies over an initial 12-month-period during which vendors must prove that the app improves patient care. Prior to prescription, an app needs to be approved by the Federal Institute for Drugs and Medical Devices (BfArM) for functionality, data security and data protection within a so-called ‘Fast Track’ procedure. If an app satisfies those criteria and fulfils a test concept to prove a positive effect on healthcare, it will be included in a health app library, the so-called ‘DiGA directory’.
“So far, no European country has developed a structured way to bring digital innovations into mainstream coverage,” says Dr Henrik Matthies, MD of the health innovation hub (hih), the arm-length body of the Federal Ministry of Health that is tasked with developing ideas and concepts for the digital transformation of healthcare. “The Digital Healthcare Act paves a clear, structured and fast way to evaluate and – if positive - integrate digital health applications into the German statutory healthcare sector, all within 15 months,” Matthies comments.
The Fast Track process
For a DiGA to be included in BfArM’s DiGA directory, it must be CE-certified to start with. Developers must submit applications via BfArM’s portal that has been operational since 27 May 2020. The BfArM has three months net for appraising a submission. In case of its acceptance, the DiGA will be provisionally included in the directory. Thereafter, it can be prescribed and will be reimbursed at a price set by the vendor for this initial period. If positive health effects in terms of medical benefits or procedural and structural improvements of a patient’s care can be confirmed during this initial period via a comparative study, a DiGA will be permanently included in the directory. At that point, the vendor must negotiate a price with the federal representation of all statutory health insurers. If both sides cannot agree on a reimbursement price after a year’s negotiation, an arbitration body can be involved.
Currently at least 15 companies have submitted an application, according to the Spitzenverband Digitale Gesundheitsversorgung, an association of organizations active in the eHealth domain. This means the first DiGAs could be preliminary listed as early as August/September 2020.
Finland working on an HTA framework
There had been no dedicated HTA framework for digital healthcare services or products until the Finnish Ministry of Social Affairs and Health commissioned one recently. “The Finnish Coordination Centre for Health Technology Assessment (FinCCHTA) is the key player and is also responsible for liaising with international HTA bodies”, explains Jari Haverinen, Specialist Digital Health Solutions’ Assessment, DigiHealth Hub at the Faculty of Medicine, University of Oulu, who has been part of the HTA development effort.
The University of Oulu and FinCCHTA published the so-called Digi-HTA framework in November 2019, for its schematic depiction.
“Our goal is that Digi-HTA becomes a guideline for developers so they know which issues they should consider in a healthcare context”, Haverinen adds, so that they can determine how suitable their products are for use in healthcare. “After assessing a product, we will give a recommendation; the key criteria being its effectiveness, cost, safety, usability and accessibility as well data security and protection”, he shares.
The framework addresses not only mobile apps, but digital healthcare services such as artificial intelligence (AI) solutions and robotics. It is currently being piloted. However, apps have not been assessed to date, but pilots will commence shortly assures Haverinen. It is planned to update Digi-HTA in the light of changes in specifications or regulations and after the introduction of new technical features.
Israel: Health apps instrumental to compete on customer service
Digital health is an important aspect of the healthcare provision in Israel. “Three years ago, Israel’s prime minister invested a substantial sum to advance innovation in digital health, focusing on data security and telemedicine services,” says Dr Eyal Zimlichman, chief medical officer and chief innovation officer at Sheba Medical Center.
Healthcare is delivered by four health maintenance organizations (HMO) - Clalit, Maccabi, Meuhedet and Leumit. Although citizens are mandated to take out health insurance with one of them, they can choose freely and switch providers. This is operational on account of all healthcare providers sharing patient information on a single platform.
These HMOs operate their own medical facilities but must offer a uniform list of health services. However, they differ in terms of customer service: “Each institution has its own portal to compete on customer service,” says Zimlichman: “The portal gives patients access to a unique set of apps e.g. those for accessing lab results or X-rays or for booking appointments with doctors,” he outlines. In fact, apps are a means to give a healthcare organization a competitive edge. However, this is not helped by the fact that HMOs do not support international standards like HL7 or FHIR: “This is a big issue for integrating medical systems and apps,” according to Dr Gidi Stein, co-founder and CEO of MedAware from experience.
Although there is widespread use of healthcare apps in Israel, there is no national HTA scheme in place. “Other than compliance with data security and protection regulations, health apps are not regulated,” says Stein. “In addition, app developers must negotiate with each organization the specifications of the app and its price. Sometimes this includes sharing revenue,” he explains.
Apps have already become an integral part of our daily lives; wellness and fitness apps have opened new opportunities to care for our wellbeing. Building a regulatory assessment framework for health technology similar to that of traditional pharmacological treatments will reap health benefits. Furthermore, and perhaps most importantly, it will ensure that these apps are secure for users to utilise.