We contacted and interviewed Roberta Sarno, Head of Digital Health at APACMed, to discuss the opportunities and challenges for the Digital Health in the APAC region.

Roberta Sarno Digital Health Manager, APACMed

Roberta joined APACMed in December 2019 to lead the new Digital Health Committee. She supports the association’s members to establish a digital health ecosystem, build knowledge and advocate for optimal policies that help digital health innovation in APAC.
Prior to joining APACMed, Roberta worked as senior consultant and business development manager at Alcimed in Paris and Marseille, France, where she supported clients in the healthcare sector on innovation and strategy projects. Before that, she worked as genetic engineering researcher at Curie Institute, in collaboration with the French startup Meiogenix.
She holds a PhD in genetics (Curie Institute, Paris), a master of business foundations (INSEAD) and lives in Singapore.

Asia Pacific: opportunities and challenges in healthcare

The demand for healthcare across APAC is growing rapidly, in both developed and emerging markets. This trend is mainly driven by population growth – with many emerging markets about to reach their “peak” population – and an ageing population. In addition to this, the lifestyle of a rising middle class has led to a surge in chronic diseases.
Healthcare solutions that are data driven, innovative and affordable, ones that re-imagine care and cost and focus on the patient are needed now more than ever before. While the technology has made great progress, providers, payers, and consumers have been slower to adopt than was anticipated, in part due to slow regulatory approvals and the lack of an adequate reimbursement model.
Having said that, the COVID-19 pandemic has been a catalyst in advancing some digital health solutions, specifically in remote patient care. However, challenges still remain: how remote care programs integrate along the continuum of care, how they qualify and quantify the value created to the total healthcare system, and how they can be scalable and sustainable.

Digital health innovations have undergone an unparalleled acceleration. Which solutions are impacting the most in the Asia Pacific region?

APAC is a very heterogeneous region, with different health systems, and various economic and political backgrounds. Despite the great heterogeneity, most of the APAC countries have seen unprecedent digital health acceleration in the past year. They rapidly introduced new technologies or increased the adopted of existing ones. A large number of technologies have allowed better and faster COVID-19 management: government chatbots dedicated to COVID-19, situation report dashboards with statistics and figures, official whatsapp accounts to inform citizens with timely and trusted updates, digital check in systems for contact tracing, telemedicine solutions to keep patients outside of the hospital, etc.
Among these solutions, some are expected to stay post-COVID-19. Telemedicine and remote care, for instance, are highly impacting the whole healthcare ecosystem. Companies are developing new solutions that patients and HCPs are increasingly using, governments are implementing new policies to ease access, and innovative partnerships are being formed among stakeholders. During covid, thousands of healthcare professionals have been trained to conduct telehealth visits with patients. Telemedicine platforms have also allowed patients in hospitals to communicate with their families. Now that both HCPs and patients have been forced to experiment the use of telemedicine, there are enough reasons to think they will keep this habit in the future.

Please tell us about APACMED, its mission and future initiatives such as ApacMed Digital Health Symposium 2021. What about the strategic topics addressed and the ecosystem involved?

Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) represents manufacturers and suppliers of medical equipment, devices and in-vitro diagnostics, industry associations and other key stakeholders associated with the medical technology industry in Asia Pacific.
APACMed strives to improve access to high quality healthcare for patients, by working in close collaboration with regulators, policymakers, healthcare providers, payers and patients to develop policies and put forward recommendations that ensure optimal care pathways for patients, from diagnosis to treatment. The association supports innovative new technologies and start-ups that improve the quality of care and healthcare outcomes. It also drives common approaches aligned with international best practices promoting speed to access via common regulatory standards; security and efficiency to adopt new digital technologies; and ethical interactions with healthcare professionals through the adherence of the Code of Conduct.

Increasingly these discussions have taken shape around Digital Health, especially given the explosion of the topic during the COVID-19 pandemic. An official committee was formed in early 2020 to work on issues such as regulatory frameworks, cybersecurity, interoperability and reimbursement. Building on this momentum and to facilitate the acceleration of digital health, APACMed is organizing the inaugural edition of their Digital Health Symposium on May 4^th. It aims to bring together international and regional leaders to share learnings around use cases that have succeeded and discuss how Asia can accelerate the implementation of digital health solutions. The Symposium is conceived as a multi-step dialogue.
In May 2021, speakers will share valuable insights on reimbursement models and challenges to successful remote care management implementations to deliver better patient outcomes. In July, policymakers from the region will discuss priorities and challenges in a closed-door round table. The insights from these first two sessions will be shared during the annual APACMed MedTech Forum in September. More sessions will be held in 2022.

This year, Frontiers has been a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition has been hybrid, combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA, Switzerland and more.

It has been dedicated to digital health innovation in the context of the “new normal”, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.

You can read the full live coverage on the pharmaphorum dedicated pages: Day 1 – Day 2

By Laura Richter and Tobias Silberzahn, McKinsey & Company

In the past years, German politicians have put digitization of the nation’s healthcare system at the top of their agendas. During this journey, one question has come up repeatedly: How much progress has been made since the Bertelsmann Foundation ranked Germany 16^th out of the 17 health systems assessed in its Digital Health Index in 2018? To generate a shared basis for discussion, an objective overview of the current situation was needed.

That overview has now been created with the new eHealth Monitor. Using 30 indicators, the Monitor allows for the exploration of digital technological maturity and infrastructure in German healthcare facilities; a review of the services and products available from providers, pharmacies, and health insurers; analysis on patients’ willingness to engage with digital health services; and evaluation of e-health-related benefits and evidence of those benefits as reflected in the latest published research. Furthermore, the eHealth app barometer measures the success of health apps based on total downloads.

Indicators are supplemented by exciting perspectives from guest contributors, which include the German Ministry of Health, the Federal Association of Managed Care (BMC), the Bertelsmann Foundation, and CEOs from three health technology companies. Also included: The patient voice and the physician perspective.

Join Dr. Tobias Silberzahn at Frontiers Health 2020

Legislative agenda

Over the past two years, Germany has made considerable headway in building the “foundation” for digitization via its legislative agenda. Particularly where the creation of regulated market access for digital health applications (DiGAs) is concerned, Germany is taking the lead internationally. It now needs to maintain the speed of the transformation process. Furthermore, it needs to catch up with those countries that have already finished creating a foundation for digital healthcare and that are now hard at work creating measurable benefits for patients, healthcare professionals, and other stakeholders.

Key insights

In recent years, Germany has progressed on the foundational elements of healthcare digitization: Progress was achieved in the areas of electronic health records, e-prescriptions, and DiGAs. Yet there are still many areas where digitization needs to be accelerated as quickly as possible: Many medical facilities are still operating in an “analog world”.

In 2019, for example, 93 percent of doctors still relied on paper-based means for communicating with hospitals. Options for ordering prescriptions via a website or for viewing documents online were available in just 15 percent of outpatient practices, and 59 percent of physicians offered their patients no digital services whatsoever^[1].

In contrast, patients are very open to digital solutions: One in three respondents of an online survey said that they already schedule doctor’s visits online, and two out of three Germans welcome the introduction of electronic health records and e-prescriptions ─ and this also held true for over 60 percent of respondents in the generation of individuals aged 65-years and higher^[2].

In the context of the COVID-19 pandemic, progress has been made in telemedicine service offers over the past 2 years: A survey of physicians conducted in the spring of 2020 showed that 52 percent of all outpatient doctors offered video consultations. That figure was just 2 percent at the end of 2017^[3].

Evidence of benefits

The eHealth Monitor also delivers fresh insights on the benefits of e-health solutions in Germany. An analysis based on the PubMed search engine shows that from 2000 to 2020, 158 articles were published on e-health solutions for Germany.

More than 80 percent of German medical research publications have confirmed positive benefits from e-health solutions, and these effects are most noticeable in improvements to patients’ health (found in nearly 80 percent of the studies analyzed), and in the form of greater cost efficiency and time savings^[4].

Of course, due to Germany’s new approval and reimbursement process for DiGAs, the number of published articles is likely to increase in the future, as e-health service providers are now required to scientifically prove the benefits of their solutions. More evidence is crucial and will be a success factor in the further implementation of e-health solutions.

hih is a think-tank of the Federal Ministry of Health – an initiative launched by the German government in 2019 as an answer to the country’s digitalization struggles. hih stayed a bit behind the curtain but the agency is in fact working directly on the implementation of Germany’s Digital Healthcare Act (DVG) with Henrik being one of its main drivers. Apart from the Digital Care Act, hih also works on many other projects in the field such as the electronic patient record, the digitization of hospitals and the digitization of Germany’s public health efforts during Covid19.

You can read more about Germany’s Digital Health Act and the “Fast Track” procedure and learn the opinions of the startups-participants in our recent interview.

– Henrik, let’s start with an overview of the recent International DiGA Summit – the event held by hih in September 2020 to discuss the Digital Care Act. What was the purpose of the event and what are your impressions of the Summit that counted with the presence of the Federal Minister of Health?

We have planned to host such an international event in English for a very long time as we realized that opening the German market to digitization means that we shall also attract the brightest solutions from all over the world. Such an approach is absolutely new for the German healthcare system which so far has been very closed, very German, very rigid and complex in structure. The ‘Fast Track’ is, vice versa, a transparent, structured and the quickest possible path for digital health solutions (in German in short ‘DiGA’) to enter the system.

To be honest, the ‘DiGA Fast Track’ is very selfish: we want to have the best possible healthcare in Germany. And to get the best possible healthcare, we need to have the best possible solutions which exist around the world. The Summit was held to make sure that everyone understands how the process works and that we are serious in attracting the global health audience. In the past I was a co-founder of two larger tech companies, hence my interest was also to make the Summit founder-oriented and explain what the law implicates for DiGA manufacturers.

In terms of reach, we were quite overwhelmed: more than 1500 visitors from more than 40 countries tuned in. It was a very positive surprise to us that a government agency is able to generate such a reach in order to explain a single law.

– During the Summit you had a live feed with the questions from the audience. Were there any unexpected questions?

Curiously enough, a question raised many times was about how much will be charged when consulting about the DVG and ‘Fast track’. Well, the BfArM guide – the best document to get started and understand the Fast Track process and criteria – is a simple PDF download, and it’s, of course, for free.

A big learning for us was that we have to make a better job in educating the non-German companies on how the German healthcare system works. We didn’t hold a section dedicated to the German healthcare system that was initially considered and I think this section would have addressed or even prevented many of the actually asked questions.

– Indeed, each single national healthcare system sets up a big barrier to entry.

Yes, one of the challenges for a digital health startup or company is the complete diversity of the healthcare ecosystems even inside the EU. All of them are so different that startups need a lot of adaptation. And my next goal would be to get a more aligned structure across Europe: if you once succeed in entering one market and comply with the regulations, say, in Finland, it shouldn’t be too much of a hassle to also expand to Germany, France or Belgium and vice versa. But we are not there yet.

At the DiGA Summit we had many policy makers also from other nations and we stimulated a lot of knowhow exchange. We realized we need to make sure that before other countries start to implement anything, they shall know our learnings and the pros and cons of our framework. Such experience transfer will help to move towards more harmonization within the healthcare systems across the European Union.

– In the event’s feed I saw some critical comments and questions regarding the ‘not digitally-friendly’ prescription procedure for the ‘Fast Track’ startups (right now the prescription procedure for the digital health apps is paper-based and also requires the patient to call his insurance company to get the activation code – editorial remark).

You can imagine that implementing the DVG required the interaction with a lot of regulatory framework, infrastructure and processes that are already in place. We couldn’t invent a completely new healthcare system from scratch. There are many requirements for the GPs that are already in practice and these requirements also touch health data privacy and security issues, its storage, access and handling. Within this given setup we had to come up with a smart idea on how to prescribe the digital solutions like ‘tomorrow‘ – because the 9 months that we had to set everything up equals in healthcare thinking ‘tomorrow‘. And we wanted to make sure that any physician and any of more than 100 statutory health insurance fund could use the prescription process from day one as well as 150 000 physicians and psychotherapists.

– To sum up, how many startups are currently in the process of applying to operate under the Digital Healthcare Act?

There are more than 20 companies already in the Fast Track application process and more than 70 had a consultation with BfArM – that’s usually the step before you decide whether to apply or not. A very promising indicator towards market acceptance is the broad range of solutions that we are going to have, from therapeutics to mental health and chronic diseases. For the first time ever, many physicians in Germany will deal with DiGA and realiz how they can actually benefit from it. Equally, millions of patients will finally have something additional to their usual therapy, something which goes beyond medication. The digital solutions will accompany them in their pocket and become a part of the patients’ everyday life.

keep an eye on our page because soon we will release also the second part of the interview with even more exclusive news about European venture capital market and digital health. Stay tuned!

Germany position as the forerunner became official on November 7^th, 2019, when its Parliament passed the Digital Health Service Act (Versorgung-Gesetz – DVG) aimed at encouraging the use of digital health applications for patients, and providing for a reimbursement mechanisms set out in the Fifth Social Security Code.

According to official projections, as of 2020 more than 73 million Germans will be eligible and for health costs reimbursed by the public health system, and now this also covers digital apps for therapeutic purposes.

90% of the German population is covered by public health insurance, while the remainder relies on private packages that, most likely, will also fall in-line to provide the same levels of coverage for digital health solutions.
This ambitious process was started by German Government Health Minister Jens Spahn, in close collaboration with the Health Innovation Hub (HIH), a task force mandated to “rethink health” from a digital perspective. That effort was led by Dr. Henrik Matthies, who has a strong entrepreneurial background in the field of health.

Which solutions will be eligible for reimbursement?

According to the new regulation, coverage will be extended to digital health solutions similar to low risk class medical devices (class I or IIa) with functionalities mainly based on digital technologies (apps or software solutions). To be eligible for reimbursement, the solution must be used for the diagnosis, monitoring and treatment of diseases or to improve the quality of treatment.

Entrepreneurs can submit applications for their digital health solutions for pre-approval and through a fast-track process. This opens the door to a 12 months in-market trial period for those solutions, during which time they will be subject to thorough testing and data collection of their efficacy.

What providers must guarantee?

Not only must safety, functionality, quality and adherence to data protection rules be demonstrated, but the manufacturer must also provide reasonable reasons (scientific evidence is not yet required at this stage) for the contribution that the product will make in terms of improving the process of patient care, quality of life and ethical and legal protections.

If the solution can prove its effectiveness in the 12 months in-market, the federal body (GKV-Spitzenverband) and the manufacturers of the solution will enter negotiations on the amount of be reimbursed for its continued presence in market.

As Dr. Henrik Matthies said, on the occasion of his deep dive at the conference Frontiers Health 2019, last November 14 in Berlin, it will take about three months to decide on the application for the inclusion of a “dam” (digital application) in the health system, so entrepreneurs involved can see the first applications accepted in the system towards the second quarter of 2020. As Matthies also pointed out, the German government has allocated a budget of 200 million euros for 2020 which will provide the pool of funds available for the first wave of digital solutions approved in the health system.

Conclusions

The regulatory framework is in its early stages and aims to be improved. Also important to note that the reimbursement only covers Class I and IIa software medical devices, while non-medical devices or digital apps combined with other medical devices are not covered by the regulation. In addition, the requirements for entering the dedicated register are very stringent. The new regulations are also testimony to a clear ambition for Germany to have political leadership (Germany’s health system being the largest in Europe) and commercial leadership, with it also being the largest healthcare market after the United States. The German government intends to play this role to the fullest extent, making the most of their Presidency of the European Semester, July-December 2020, which also opens the door for Germany to propose and launch an initiative on health data management across all of Europe.

As Germany has taken the initiative to show the way, we can only hope for a spill-over effect on all the other EU countries, and the benefits that EU citizens can gain from this welcome change.

The session which was jointly organized by Reserach2Guidance and Healthware took place during last week’s Frontiers Health Conference in Berlin.

It brought together representatives from big payer organizations such as Swiss Re and Allianz, as well as digital health Start-Ups like Kaia Health, Amicomed or hi.health.

The transformation of the payer industry is literally at our doorsteps as the results of Research2Guidance’s recently published global study showed. In regions such as North America or Asia, a plethora of new service and business models are already emerging.

Many of the newly created business models aim at either acquiring new members or provide better service to existing members via digital platforms or digitally assisted services. Examples are BIMA from Sweden offering microinsurance for emerging markets, Vitality from the UK or Zhong An from China, both offering activity-based freemium health insurance coverage. US-based Oscar Health offers its customers digitally assisted concierge services to better manage them and supply more convenient care and assistance.

Other digital business models target specific customer segments such as employers and aim to offer them health insurance platforms from which they can easily select different health plans for their employees and manage them. This is what companies such as bind and Collective Health in the US are doing.

Clover Health is also targeting a particular segment, in their case, these are high-risk patients which they manage better using AI-based tools and services.

US-based company Patch features yet another new business approach: they are licensing their platform for reimbursement optimization to health care providers who can then instantly tell their patients what the reimbursed amount will be and how they can best submit their claim.

These new entrants to the health insurance market could already raise almost 2 billion USD in funding.

Europe is not going so fast, nevertheless, some first-movers have already proven a good traction in the market.

Read the full article on research2guidance.com

2 days of conference activities to dive into guiding themes inspired to healthcare trends and innovation topics: Breakthrough Innovations, Scientific and Medical Validation, Reimbursement and Business Models, Strategic Partnerships, Digital Therapies, Design for Health Transformation, Funding, M&A, path to value, Health Insurance Innovation.

2017 in numbers

500 delegates, 30 countries, 74 presentations, 130 startups and over 70 investors.

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