1st June 2023
Since 2019, digital health applications can be reimbursed by health insurance providers in Germany, and among the already approved solutions, there is an innovative digital physical therapy app developed by a Romanian start-up. However, Romanian doctors, unlike their German colleagues, cannot yet prescribe it to their patients. According to experts who participated in a roundtable discussion organised by EIT Health, part of the European Institute of Innovation and Technology (EIT), a body of the European Union, the next couple of years offer a great opportunity to leverage healthcare innovation in Romania as well.
The German model
In 2019, the German Digital Healthcare Act introduced a new approach to market access for reliable and safe digital health applications. The legislation aimed to select digital solutions with proven clinical benefits from the 400,000+ health and wellness apps. Since then, digital therapies have become a new form of medicine called digital therapeutics (DTx). DTx can now be prescribed by German doctors and reimbursed by public payers, similarly to traditional medications and treatments.
DTx must undergo a thorough investigation before they can be approved as digital health applications (Digitale Gesundheitsanwendungen, DiGA). If they meet the requirements related to safety, functionality, quality, data protection, data security and interoperability, they are eligible for regulatory review and entry into a DiGA Directory maintained by the German Federal Agency for Drugs and Medical Devices. The positive care effects of DTx can be demonstrated in two ways: in a 12-month ‘fast-track’ or if a developer delivers evidence, for example, clinical trial results. When all the criteria are met, the digital solution enters the healthcare system and can be reimbursed by all of Germany’s statutory health insurers.
A Romanian success story in Germany
So far, around 40 DTx has been introduced into the DiGA Directory in Germany. One example is a product called re.flex, developed by Romanian start-up Kineto Tech Rehab. Re.flex is a digital assistant for musculoskeletal physical therapy, helping to treat knee pain at home. It gives patients clear and precise instructions and live 3D feedback on the correct and incorrect execution of the exercises, both acoustically and visually. CEO and Co-Founder Camil Moldovenau started working on the solution in 2015 after he needed to undergo several surgeries and months of physical therapy following a knee injury during the European Championships of Brazilian Jiu-Jitsu. Now, the company’s solution is ready to help patients on a broader scale.
The product, which received support from several EIT Health programmes, is the first DiGA-approved one that includes a hardware element apart from the digital app and is one of the first coming from outside Germany. Reflex is not the only healthcare innovation success story from Romania. Since the country’s EIT Health Hub, FreshBlood HealthTech Community was established in Cluj-Napoca in 2018, a total of 17 start-ups received support from EIT Health, reaching a total valuation of €53.5 million. Success stories include .lumen glasses, a “digital guide dog” for blind people; XVision, which aims to change radiology by implementing an AI solution; and Stressless, which developed a wearable device called TULLY for children diagnosed with ADHD.
Signs of progress in recent years
However, while German patients can now enjoy its benefits, patients in Kineto Tech Rehab’s home country cannot – at least not on prescription. Why? To answer the question, EIT Health organised a series of roundtable discussions across Europe, including Romania, in 2021 and 2022, to discuss the German DiGA model and its potential to inspire digital health regulatory frameworks in EU countries. The events brought together experts and stakeholders from healthcare, medical device regulatory affairs, academia, and business.
According to the summary of the discussion, published by EIT Health in March 2023, Romanian healthcare is undergoing digital transformation. Recently, there have been relatively low awareness of the benefits of digitalisation in the medical community and even some resistance, which stemmed from concerns about an inspection of work through access to electronic records. And although widespread internet access and smartphone adoption are high, digital health literacy and awareness of digital health benefits and tools in the community has been low.
Despite all the hurdles, there are several signs of progress. The Electronic Health Record – EHR (Dosarul Electronic de Sanatate) rollout started in 2013 and was initiated by the National Health Insurance House (Casa Nationala de Asigurari de Sanatate, CNAS). The adoption of the EHR is relatively low since it’s necessary for health providers for reimbursement purposes. Digital health innovations like telemedicine are being adopted faster in private healthcare facilities as out-of-pocket expenses. CNAS also introduced reimbursement for remote teleconsultations during the COVID-19 pandemic and legislation is currently being finalised.
“It is very encouraging for all healthcare innovation stakeholders in our event to witness the opening of the authorities and the ability of Romanian start-ups to access advanced European markets, like Germany. These examples can become benchmarks that will encourage future innovators to build connections and augment their aspirations”, said Ion-Gheorghe Petrovai, Co-Founder and Director of Innovation at FreshBlood HealthTech, one of the EIT Health RIS Hubs, after the Romanian’s roundtable.
Great opportunities for future growth
According to the experts, the next couple of years present a great opportunity to boost digitalisation in Romania, including in the sphere of healthcare. In Romania’s Recovery and Resilience Plan (RRP), roughly 20% of the grants will support the digital transition, including ca. €100M for telemedicine and €400M for the digitalisation of hospitals. Prioritising digitisation as part of achieving national health goals in EU funding projects could speed up the use of DTx in Romania. To capitalize on this opportunity, the roundtable participants have articulated several recommendations for the Romanian healthcare system.
“We need to leverage know-how exchange between our national authorities and corresponding institutions from countries with more experience in digital health innovations rollout in the public health system, such as Germany. A next step would be launching a pilot project for the reimbursement of telemedicine services and DTx in the national health system”, explained Ion-Gheorghe Petrovai. “In the meantime, we need to invest in digital skills among healthcare professionals through initiatives such as the EIT Health programme HelloAI RIS. We also need to demonstrate how broader use of DTx supporting them in their work could tackle their shortages and improve access to healthcare.”
The EIT Health report offering pan-European overview on the state of the digital health and care transformation in the individual Member States can be found at: ‘Digital Medical Devices: Paths to European Harmonisation.’
 European Commission. Recovery and resilience plan for Romania. Available at: https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility/recovery-and-resilience-plan-romania_en