What does it mean when a whole country decides that digitization is the right strategic move for its healthcare system? The case of the federal republic of Germany in the past few years provides a fascinating case study. Appropriately, on Thursday, August 12 at HIMSS21 in Las Vegas, a panel of experts and leaders gathered both in person and remotely to discuss “Germany: The Digital Transformation of a Country.”
On Thursday morning, HIMSS president and CEO Hal Wolf moderated a panel entitled “Germany: The Digital Transformation of a Country.” Appearing remotely from Germany was Gottfried Ludewig, Ph.D., Director General, Digitization and Innovation, in the Federal Ministry of Health (in German: Bundesministerium für Gesundheit). In person at the Sands Convention Center were Wolf; Henning Schneider, CIO at Asklepios Kliniken Gmbh & Co. KgaA, a large integrated health system in Hamburg; and Anne Snowdon, R.N., Ph.D., director of clinical research at the Chicago-based HIMSS.
At the outset of the session, after introductory remarks by Wolf, Dr. Ludewig gave a presentation about the current state of digitization in the German healthcare system.
To begin with, Ludewig noted, as recently as 2019, the German healthcare system was under-developed with regard to digitization. Indeed, he referenced a report entitled “#SmartHealthSystems International Comparison of Digital Strategies,” published on September 4, 2019 by BertelsmannStiftung. The authors report assessed Germany’s “digital health readiness score,” based on a range of factors, at a relatively low level of 30.1, lagging far behind the scores of such countries as Estonia (86.1), Denmark (66.0), Spain (76.9), Portugal (68.6), Austria (60.7), Italy (56.6), Switzerland (44.0), and France (33.2), and just ahead of Poland (25.9).
Why was Germany so far behind its European counterparts in healthcare digitization, as recently as just two years ago? “There were concerns of practitioners and other things that had blocked us from fostering digitization.” Ludewig said. But, since then, he said, “What changed in 2018 and opened the window of opportunity was a number of things. First, there were the professional need and professional perspective that changed. Doctors who use digital applications will replace doctors who still use index cards, because patients will no longer accept doctors who are not digitized. People are experiencing in their daily lives how digitization helps them, and are asking for it” in patient care.
“Most of all, for Germany,” Ludewig said, ‘it was about political will. It was about tacking responsibility. And when Health Minister Spahn took office, it was his key motive to move forward in digitization,” he said, referring to German Federal Minister of Health Jens Spahn, who was appointed Federal Minister of Health in March 2018 by Chancellor Angela Merkel. “What was required were three things: professional need, societal attitude, and political will.” Further, he said, “We love to be champions of theoretical space; but he has helped us to shift forward into making this practical. We wanted to change to active leadership and management. That had not existed in the Federal Ministry of Health. And he quoted Minister Spahn as having stated that, “When it comes to digitalization, we want to play in the Champions League.” Further, Ludewig said, “It’s not just because it’s hip. Digitalization is already transforming our society, and it transforms our healthcare system. And moreover, it improves care. It helps us to offer better care.” And he cited an August 2018 study by researchers at Charité – Universitätsmedizin Berlin (one of the leading medical research centers in Germany) which asserted that “Digitalization is not a buzzword and will not disappear if we ignore change long enough; digitalization is present in the daily lives of citizens but the health system remains largely paper-based; and, digitalization improves care.” Indeed, that study found that the use of telemedicine reduces mortality from 11 percent to 8 percent. As the study’s abstract states, “Telemedicine saves lives. Telemedical interventional management reduces hospitalizations and prolongs the life of patients with heart failure. Researchers have shown that these findings apply equally to patients in rural and in metropolitan settings.”
The link in German to the “Fontane-Studie” can be found here. The study’s authors, Thomas Rachel, Parliamentary State Secretary of the Bundesministerium für Bildung und Forschung, or BMBF (Federal Ministry of Education and Research), and Prof. Dr. Friedrich Köhler, write that “Our study shows that with the support of telemedicine, people with heart failure can live longer. This is both a technical development and a clinical research project in one. Together with partners, we have developed a technical system for measuring and transmitting data, such as patients' blood pressure. We then tested this system for medical efficacy. So we developed a technical innovation and then achieved medical progress.”
Ludewig told the HIMSS audience that there are “four pillars” to the federal government’s digitization initiative. The first, he said, is “leadership. For us, it’s no longer just a question of passing a bill through the German parliament. We aim to manage to co-manage all implementation.” Second, he cited “governance: we took over 51 percent of the national ehealth agency, and connected it with the doctors’ association. Third, the art of legislation. And the fourth pillar,” he said, involves “new forms of dialogue with stakeholders and innovators.”
Ludewig further noted that, among the elements of the broad federal initiative have been ownership of both the initiative and its implementation; the development of a new governance structure for the national eHealth agency, the Gematik GmbH; new approaches to agile and adaptive legislation; and new forms of dialogue with stakeholders and innovators. Importantly, he noted, “Beginning in January 2022, every German will have access to an electronic health record,” known in Germany as an ePA. Electronic prescribing is also finally happening in Germany, as are, under the heading of telemedicine, video consultations, teleconsultations, and telemonitoring.”
Also significantly, for the first time ever, Ludewig reported, there will be direct federal investment of 3 billion euros from the federal budget, along with 1.3 billion euros in funding from the states, known as Länder, which in Germany have a great deal of autonomy, as do the state governments in the United States. Under that program, the goals will be to improve and modernize emergency medical care; create digital patient portals; provide digital care and treatment documentation; establish partially or fully automated clinical support systems; and create a digital medication management program. There will be broad assessments made to measure the initiative this year and again in 2023.
What’s more, the federal Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), or Institute for Drugs and Medical Devices, the German equivalent of the FDA in the United States, has approved the principle of software as a medical device. As a result, low-risk health apps or browser-based web apps can apply for listing by the BfArM. The procedure allows for preliminary and permanent listing; after approval, an app can now be prescribed by physicians and psychiatrists. Indeed, Ludewig noted, “We have around 20 applications already listed,” including for cancer, depression, tinnitus, diabetes, arthritis, obesity, anxiety, addiction, panic disorder sleep disorder, stroke, migraine. These apps can be prescribed and reimbursed for, he noted. Here is a link to an explanation of the new digital health applications (DiGA). This appears to be novel in Europe. Here is an English translation of information on a page in German about these apps: “What is a DiGA? DiGA in the sense of this directory are products that are intended, for example, to recognize or alleviate diseases, which support the diagnosis and which are largely based on digital technology. These are low-risk digital medical devices that directly benefit you as a patient. The digital health applications include apps or browser-based applications. A DiGA can be used either by the patient alone or by the doctor and patient together. DiGA can be used e.g. in combination with other devices such as heart rate monitors, other DiGA or other software. If this is the case, you can see in the directory whether these additional components can also be reimbursed by your health insurance company or what additional costs may be associated with their use. It is important that the digital health application through its technology must offer a “positive supply effect” for your individual situation. The BfArM will determine whether this is the case in an assessment procedure.”
And there’s more. Ludewig described “Smart Health,” the new data research center, which he described as a “new framework for data use for research purposes: creation of a protected and privacy-compliant space for billing and administrative data.” He and his colleagues envision “gradual expansion of the available data; implementation based on billing data. No opt-out possibility. We merged all the data from the German systems. And they can voluntarily donate their EHR data from 2023 on. Hopefully this will become one of the largest standardized data sets in the world, especially in Europe.”
Panelists see broad opportunities going forward in Germany
HIMSS’s Wolf asked Ludewig, Schneider, and Snowdon all to share their perspectives on all these developments with the audience. Addressing Ludewig, Wolf said, “You and I met in Berlin in 2019 and had some discussions as this legislation was just beginning to get proposed. This is a lot of political will. Jens was there in the leadership, and then you took on a project. Why step into that breach?”
“For me, it’s one of the most fascinating areas,” Ludewig responded. “The healthcare system and the change we’re facing is too often discussed as a threat. And it’s not a threat. The transformation we are facing is hope, because it gives us the opportunity to treat diseases in a better way compared to how we do it today, and also to steer the system in a different direction. I’m an economist by training. And I always ask my self—we spend a lot of healthcare, which is good, but how can we spend the money and have a better outcome and an impact on everyone’s life? I’m so convinced that this is the future: a good future for patients and doctors. We really wanted to force this change. And we truly believe that this is the right way. And I think that the German system is working quite well. And this system really was established in 1870, by Bismarck. And I want this system to be still running in a good way in 2030. If we were going on has we had in the past 50 years, this would not go well. And I can tell you it’s possible.”
“You’re going to have to go through implementation here, and move that culture change,” Wolf said, addressing Schneider. “How will you handle the change management?”
“I think that Mr. Ludwig hit the mark,” Schneider said. “You have to have strong leadership. We’ve now had strong leadership in the Health Ministry. Everybody said clearly that we want to become a digital health system. This was a major theme. Looking back on 2010, as we discussed this with doctors, the doctors are demanding this now. It’s no longer a question as to whether the doctor wants to use a paper record; he wants to use the digital system. He’s frustrated because of a lack of convenience. This is what we have to do. When you see in the exhibition halls here, you see that the tools are there, tools for speech recognition and documentation, for example. What’s really, really important: we’ve had islands of excellence. You build some great systems in one hospital, but it wasn’t connected, and in another hospital, it was something completely different. This is a chance for us in Germany to catch up and to become a fast-working digital system.”
“Do you think that without the ground-laying before 2020, you would have been able to respond to the pandemic as well?” Wolf asked Ludewig. Ludewig responded that “It was like jumping on a moving train. The train was already running fast.”
Turning to Snowdon, Wolf said, “Anne, a big part of digital transformation is around outcomes, and there’s a component involving putting it in correctly. The German system is a good system, so this is a good-to-great kind of conversation. What do they need to be thinking about?”
“The German strategy that Dr. Ludewig has defined is one of the most impressive I have ever seen,” Snowdon said. “For the last 20 years on innovation research, the most critical factor that makes innovation work or not, or embed and scale, is the leadership: the vision, the tools, the accountability, all the things that we learned from Dr. Ludwig. That’s core also to a digital ecosystem. The interoperability, all those pieces that you suggest had started some time ago but that COVID19 has accelerated, become a critical dimension to build on. But as a nurse, what’s really exciting is that Germany is reaching out to every German citizen, engaging people where they are with digital tools. Now they have this incredible opportunity where patients report their outcomes.”
What’s more, Snowdown said, “This will be the first of its kind in many ways. Outcomes is not just about morbidity or mortality or system data; what’s critically important is, are health systems achieving value for the people they serve? And how can you reach full health potential, how can you do that? The outcomes potential in Germany will set a global stage of leadership. And it’s not just system outcomes; it’s right down to the individual, which allows for analytics tools. Unique features of population segments, and where are those segments that you can transform care to achieve better outcomes? It’s no longer one-size-fits-all. It’s so incredibly exciting, and this work is just globally exceptional. And measure, measure, measure, as you’re moving forward, to know if you’re moving in the strategic direction set out? You need to measure what’s working and not and pivot to what’s working.”
Schneider, a CIO, noted that “We have to use the measurement to get transparency into this digital system. We have to understand how we can find out what our real status is. I will be very curious as to what we’ll see after the first measurement. In 2010, when we did a first measurement, we suddenly saw where we were, but also where we needed to go.”
