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Digital Health Apps in Germany – an Update on the DiGA Journey



Digital therapeutics, or Digital Health Applications (DiGA), are apps for the detection, monitoring, treatment, or alleviation of medical conditions. The DiGA initiative is part of the 2019 Digital Healthcare Act (DVG) that sets the legal framework for doctors to prescribe DiGAs to the 73 million citizens insured with a statutory health insurer that reimburses their use, and has been recognised as a pioneering approach globally. To classify as a DiGA, apps that are CE-marked as Class 1 and 2a low risk medical devices must have successfully passed the Fast-Track assessment process by the Federal Institute for Drugs and Medical Devices (BfArM). The assessment appraises an app with regards to its safety, performance, data protection, information security, medical effectiveness, interoperability, its ability to bring positive health effects and advance the healthcare system, among other things.

The first DiGAs were authorised for use in October 2020, and now a total of 24 are approved (as of 29 Nov 2021). So far, 106 applications were submitted, of which six were rejected and 52 withdrawn – on the grounds of inappropriate study design (42%) and inapt systematic data evaluation (42%). Currently 24 apps are under review. The approved DiGAs cover a range of medical fields including: cancer (2); cardiovascular system (1); ears (1); hormones & metabolism (3); muscles & bones & joints (3); nervous system (3) and psyche (11).

Initially, DiGA developers stemmed from the startup domain, but interest from medtech and pharma companies – as well as industry associations is increasing. The majority (86%) of applications are “made in Germany”, with 10% of DiGA applicants based in other European countries and 4% in the US and New Zealand.

According to the health innovation hub (hih), a think-tank, and implementation supporter for the digitisation efforts of the German Federal Ministry of Health, doctors prescribed DiGAs around 50,000 times between October 2020 and November 2021. This was slightly below the hih’s expectations – though could be attributed to the time it takes to educate doctors on the use of these new tools.

Best practices must be shared, and opinion leaders need to be involved to drive up prescription numbers. The fact that some DiGAs are more commercially successful than others suggests that vendors must engage in marketing activities to familiarise doctors and patients with their products. DiGA developers have conceded that they had underestimated the effort it takes to commercialise them.


The 2018 study ‘Smart Health Systems, International comparison of digital strategies’ examined to what extent 18 selected countries had digitised their healthcare delivery. The fact that the study ranked Germany in 17th place may have acted as a overdue wake-up call for action. The Federal German Health Minister, Jens Spahn, who assumed office in March 2018, has enacted a series of laws that advance the digitisation of healthcare delivery in Germany.

Despite the slow start compared to its European neighbours, Germany’s digitisation efforts leaped forward with the launch of DiGAs. There are several notable leading approaches. Firstly, apps can get prescribed and reimbursed, with the latter being dependent on an app’s ability to improve patient-relevant structures and processes in healthcare such as facilitating access to care or coping with illness-related difficulties in everyday life. However, DiGAs do not stand alone and are one piece in a digitally supported healthcare delivery ecosystem, with other elements such as electronic health records (EHR) and e-prescribing incorporated. Therefore, the BfArM emphasis on the interoperability of DiGAs is becoming increasingly important to ensure that the data captured via an app can be transferred into a patient’s EHR and integrated into doctors’ workflows.

Based on the positive reception of DiGAs, the Federal Health Ministry hopes that the range of medical conditions supported by DiGAs will continue to grow. Moreover, the DiGA-concept will be applied in the nursing field with the creation of the so-called digital nursing applications (DiPA) to be launched on 1 January 2022. Their aim is to assist organising and managing nursing tasks, especially with a view to support those looking after relatives at home. Additionally, DiGAs offer an opportunity to collect real-world data that can be used for population health management and research purposes to advance patient outcomes. However, these are cleatrly early days for DiGAs and the BfArM announced plans to tighten the certification process. There have also been calls to make DiGAs available to the ten million privately insured citizens.


The German approach has inspired other countries to look closer at reimbursable apps. In October, French President Emmanuel Macron announced plans to replicate the DiGA reimbursement scheme and the hih has also reportedly had interest from North America and other European countries to integrate elements of the DiGA approach into their eHealth strategies. Representatives from Belgium, Denmark, Finland, France, Ireland, Luxemburg, Spain and Sweden spoke at a recent hih event in a joint effort to harmonise market access for reimbursable medical apps across Europe. As they all face similar challenges, they felt that the German DiGA approach was helpful and could be used as a template for their own respective efforts. They agreed to continue with multilateral talks, also on an EU-level.


“There is a market for digital therapies. We did something very non-Germanic by trying something new and improving it at the same time in an agile way,” commented Dr Gottfried Ludewig, Head of Digitisation and Innovation, Federal Ministry of Health.

Dr Wiebke Lobker, Head of Innovation and Change Management, BfArM, emphasised that DiGas are part of a connected healthcare system: “Positive healthcare effects are important, but increasingly so is interoperability, so that data can be transferred to EHRs. There will be more future requirements regarding data transfer to enable a connected eHealth ecosystem.”

“DiGAs need to be integrated into the physicians’ workflows and included into EHRs. We need clear processes for DiGAs to be reimbursed from private insurers. Other countries are looking at Germany to copy the processes. Nobody thought this would be possible for Germany to become a leader in some eHealth respects,” said Nora Blum, Co-Founder, Selfapy.

Furthermore, Christian Oberle, President, CNS, Luxemburg concluded: “Germany succeeded in a short time frame, which is inspiring. DiGAs create a dynamic that helps the digitisation of healthcare. This gives hope to others”.

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Singapore’s Public Health System Rolling Out the Clinician’s ZEDOC Platform



Singapore’s health tech agency Integrated Health Information Systems has partnered with Auckland-headquartered digital health firm The Clinician to deploy a patient-reported outcome and experience measures platform across the island state’s public healthcare system.


The Clinician’s ZEDOC platform, the company describes, assists healthcare providers in managing patient-generated health data outside the hospital through digitisation. Integrated with HIS, the system supports timely exchange of health data and information between providers and patients, including subjective PROMs and PREMs, objective wearable device data, and other communication or educational materials. By streamlining the digital collection of critical health data, ZEDOC is able to render real-time, actionable information crucial for improving health outcomes and experiences.

The partners are working on multiple ZEDOC integrations with existing health information systems (HIS). A privacy-preserving hybrid infrastructure has been implemented which ensures that all personally identifiable information stays within the IHiS’s private health cloud while all anonymised health data are collected through a secure commercial cloud platform.


Singapore intends to measure and improve health outcomes and patient experience with the rollout of The Clinician’s ZEDOC platform. Their partnership will “bolster patient engagement and enable clinicians to more effectively assess patients’ health status before, during and after receiving a health service – closing the loop when they are outside the hospital,” said The Clinician CEO Dr Ron Tenenbaum. It will also allow providers to deliver “more holistic and personalised care for patients by taking into account their perspectives for the first time,” he added.

To demonstrate the benefit of routine collection and analysis of PROMs, The Clinician shared that this has resulted in over 50% reduction in 90-day complications for hip and knee surgery patients in one study and a five-month improvement in the survival of cancer patients in another.

Among benefits for care providers, the ZEDOC integration will replace existing paper-based forms with an integrated digital platform that automates data capture, as well as benchmark outcomes across providers to reduce variability and waste. For patients, they can become more involved in the treatment decision-making and be informed early of health risks and warning signs.


Last month, Cabrini Health and The Alfred, two of the largest healthcare providers in the Australian state of Victoria, deployed the ZEDOC platform to automate the collection and analysis of health data from colorectal cancer patients. The installation is said to adhere to the colorectal cancer standards outlined by the International Consortium of Health Outcomes Measurement.

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EU Analysis Highlights Digital Health Lessons From COVID-19



An EU analysis has outlined the effect of COVID-19 on healthcare systems in Europe and the role of digital innovation in building their resilience.

Experts from the Organisation for Economic Co-operation and Development (OECD) and the European Observatory have published a set of 29 country health profiles, covering all EU member states, as well as Iceland and Norway. A companion report also highlights a selection of cross-country trends.

Speaking at a virtual launch event on Monday (13 December), Josep Figueras, director, European Observatory, highlighted two main lessons learnt from the use of technology in the pandemic.

Using telemedicine as an example of digital health innovation, he said the number of teleconsultations had increased in all EU countries during 2020. However in some countries, such as France, teleconsultations had decreased when lockdowns ended.

“The key issue here is how we harness and sustain innovation – how we make sure that these improvements in the use of telemedicine (as an illustration of the use of other digital technologies) can be maintained and sustained to increase the effectiveness of the health system,” Figueras said.

He also highlighted that the technology for telemedicine and other innovations was already available in many European countries before the pandemic but was not being used.

Figueras asked: “What did we do within the pandemic that literally within a couple of weeks, we got all this telemedicine in place?”

To sustain the use of telemedicine and other health technologies, he said it was important to look at the regulatory measures, financial incentives, training and changes in culture needed.

“Something the pandemic has taught us loudly and clearly is the importance of digital innovation – not only the new technologies, but the ability to implement them,” Figueras added.


The State of Health in the EU cycle is a two-year process initiated by the European Commission in 2016, designed to improve country-specific and EU-wide knowledge in healthcare.

It aims to gather data and in-depth analyses on health systems and make the information accessible to policy makers and stakeholders.


During the pandemic, digital tools have been used in the EU to boost public health measures such as the implementation of the EU Digital COVID Certificate, vaccination booking systems, and cross-border interoperability for contact-tracing apps.

There has also been investment in EU-wide COVID recovery initiatives such as the EU4Health programme.


Maya Matthews, head of unit performance, European Commission said: “COVID-19 illuminated the fact that in many European countries we do not have a strong public health system. We cannot do testing and tracing. Even surveillance is done sometimes in a very fragmented fashion.

“I think if one thing comes out of COVID-19, it’s to say that public health matters – that public health is a very important part of health systems and has not really received the attention it deserves.”

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Clinical Messaging Platform Hospify to Close, Bupa Arabia Invests in Global Ventures, and More News Briefs



Clinical messaging platform Hospify to close

British healthtech startup Hospify has announced it will close its secure clinical messaging platform on 31 January 2021.

Hospify said it suffered a decline in demand after the government suspended the UK 2018 Data Protection Act in relation to healthcare last year for the duration of the COVID-19 pandemic.

It also cited difficulties caused by “post-Brexit uncertainties surrounding the future of the UK’s data adequacy agreement with the EU”.

A statement from the Hospify team says: “It’s a sad end to a wonderful vision, a vision of universal health care communication that was both free of data exploitation and free at the point of use.”

Insurance giant Bupa Arabia invests in Global Ventures

UAE-based international venture capital firm Global Ventures has announced new investment from Bupa Arabia, the leading health insurance company in the region.

Bupa Arabia’s participation in Global Ventures Fund II as strategic partner aims to foster the healthcare ecosystem in the region and particularly in Saudi Arabia.

The investment is part of the Bupa Arabia’s strategy to participate and invest in disruptive healthcare and insurance technologies, amongst other targeted growth sectors.

Noor Sweid, Global Ventures founder and general partner, said: “Bupa Arabia shares our outlook and ambition on the digital health sector, and its potential for technology and innovation to deliver long-term economic benefits particularly in emerging markets.”

Liverpool Heart and Chest Hospital achieves EMRAM Stage 6

Specialist NHS trust Liverpool Heart and Chest Hospital (LHCH) has been awarded Stage 6 of the EMRAM, or Electronic Medical Record Adoption Model, by HIMSS.

The EMRAM measures the adoption and maturity of a health facility’s inpatient EMR capabilities from 0 to 7. Achieving Stage 6 means the trust has established clear goals for improving safety, minimising errors, and recognising the importance of healthcare IT.

Kate Warriner, chief digital and information officer said: “Digital excellence must be the cornerstone if we are to continually improve the care that we provide for our patients in the years ahead. Therefore, whilst we are rightly proud of this achievement, we have ambitions for further pioneering innovation and advancing our use of technology to become a Stage 7 hospital.”

More than $110m raised by Sheba’s ARC Innovation Center

Israel’s Sheba Medical Center has announced that six companies from its Accelerate Redesign Collaborate (ARC) Innovation Center raised more than $110 million (EUR97.2m) in 2021.

ARC brings new technologies into the hospital and community ecosystem focusing on digital health technologies including precision medicine, big data, artificial intelligence (AI), predictive analytics, telemedicine and mobile health.

Sheba MedTech startups receiving investments this year included: Aidoc, BELKIN Laser, Starget Pharma Append Medical, Innovalve Bio Medical and TechsoMed.

Professor Eyal Zimlichman, ARC director and founder, said: “The ARC Innovation Center has been focusing on ground-breaking, innovative technologies with a prime directive to redesign healthcare.”

Konica Minolta named as part of NHS Digital Documents Solutions framework

Konica Minolta Business Solutions (UK) Ltd has been named as one of 46 suppliers on the new ?5 billion Digital Documents Solutions framework.

The firm will provide solutions across five key areas: internal print, external print, digital mail room, scanning and electronic document management solutions.

Jason Barnes, head of public sector, Konica Minolta, said: “Having been chosen through a competitive tender process, we are especially pleased to be newly appointed to the LPP framework, which deepens and furthers our reach into the NHS health sector.”

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