· Telehealth consultations become the norm. HCPs are allowed to actively promote their telehealth services to patients on e.g. their websites. Pricing for telehealth services is still negotiated but is supposed to be solved soon.
· Improved access to patient data for research. German public health insurances are forced to send anonymized member demographics and health data to a central database managed by the German government. Research organizations and universities can request access to data for research purposes.
· Every insured member will have access to an electronic health record. By January 2021 every member of a public health insurance (72 Mio) must have access to an electronic patient record.
· HCP patient communication and prescriptions is moved to electronic channels. Electronic prescriptions for medication, remedies and aids, doctor letters and certificates of disability for employers will now be allowed. Traditional fax communication is made less attractive.
· Pharmacies, HCPs and hospitals are forced to connect to secure communication networks. Every pharmacy (Sep 20) and hospital/HCP (Jan 21) must connect to the German secure health data network provided by the Gematik. In case of non-compliance, there will be financial penalties.
· Health insurers will offer online member sign ups
· Health innovation will be financially supported. German government prolonged EUR 200 Million yearly funding for 4 years to support innovation projects in healthcare.
Breast Cancer Patients and Survivors in the E.U. Workforce and Demographics. A closer look at Germany
The underlying level of breast cancer in Germany is about the same as that of its immediate neighbors, which is already large. Germany’s burden, however, is multiplied by the country’s demographic aging, which has given the highest median age in Europe.
The numbers show the extent of the issue. Germany’s age-standardized breast cancer incidence, at 91.6 per 100,000, 2 exceeds the average for western Europe (91.1) and of nearby northern Europe (89.4) only slightly. These numbers are substantial—Germany has the 11th-highest age- standardized incidence globally—but they are consistent with those of similar developed countries.
The crude incidence statistics, which do not adjust for Germany’s older population, tell a very different story.
Germany’s incidence figure, at 171.5 per 100,000 women in 2012, is the world’s third-highest and well above the EU’s figure of 139.5. However, Germany has a modern healthcare system, which explains its five-year survival rate of 88% in 20123—about the norm for wealthy countries. The net result is a high number of survivors. The five-year prevalence figure is 765.7 per 100,000, but because of Germany’s large population, the absolute number of such survivors in the country, nearly 280,000, is Europe’s highest.
Changes in employment laws and patterns make these crude incidence and prevalence figures of particular relevance for workforce issues. To address the implications of its aging population and its tradition of early retirement, Germany enacted two reforms in the previous decade. First, it reduced
significantly the maximum duration of unemployment bene t payments to people aged 55 and older, from 36 to 18-24 months according to their age and duration of employment, making what had been used as an early bridge to retirement less attractive. Second, in 2012 the country began raising the retirement age from 65 to 67, a process that will finish in 2029. In 2017 the retirement age is already 65 years and 6 months.
These changes have had the desired effect on workforce participation levels for older Germans. According to OECD data, although the population-wide labour force participation rate barely changed between 2006 and 2015—going from 75% to 77.6%—among women aged 40-64 it grew from 70.2% to 76.5%, bringing the latter figure in line with the overall rate. The increase in employment among older women occurred almost entirely among those aged over 50 and was particularly marked among those aged 60-64, for whom the participation rate more than doubled, from 24.4% in 2006 to 50.2% in 2015. Read more
Conquering the German Market: DiGA “Fast Track” Kit for Digital Health InnovatorsWith its newly adopted Digital Healthcare Act (DHA; Digitale‑Versorgung‑Gesetz, DVG), Germany now positions itself as a top country for digital health innovation. Telemedicine and digitization are becoming the new normal. Funding options are increasing to push back the barriers of digital health innovation. While the Germans were already known for their robust and above-average effective healthcare system, the DHA will now make their healthcare market more attractive than ever, unleashing countless new opportunities for digital health startups and innovators. But how do you conquer such a market?
#1 What you need to know to successfully scale-up your digital health innovation in GermanyThe German Healthcare Market – OverviewWith the largest European healthcare system counting 72 million insured citizens, Germany has always been a very attractive market for health actors, not only for internal players, but also globally. However, until now, breaking into the digital health market was legally more challenging than rewarding, making it very difficult for health startups and entrepreneurs to pioneer into the German eHealth scene. It all changes now with the adoption of the Digital Healthcare Act.
The Digital Healthcare Act – What’s new?The Digital Healthcare Act was adopted in 2019 by the German Parliament and entails the new rules to support digital health innovation in Germany. If the German healthcare system was strong thus far, it was also filled with paperwork and not legally welcoming in regard to digital innovation. The new Act addresses these issues and opens the German healthcare market to a new era of digitization and unlimited possibilities for groundbreaking eHealth solutions.
Starting from January 2020, the Act will bring revolutionary changes to the German Healthcare Community, opening the doors to infinite opportunities for the visionary eye. Among them:
Despite the many possibilities that the DHA offers, unleashing the power of digitization over healthcare involves a lot of risks for personal health data and patients. Companies that are taking the leap into pioneering health data will have to comply with several standards and Regulations in order to ensure that patients are safe and data are secured.
The Regulatory framework on top of your new eHealth Solution will be composed of:
#2 How to ensure that your Digital Health Innovation gets adopted and reimbursed in GermanySoftware as a Treatment – New opportunities?Among all the changes that the DH Act will bring to the German healthcare system, one that will massively and positively impact eHealth innovators and entrepreneurs is the one that allows doctors to prescribe medical apps. By making Digital Health Apps (“DiGA” in DHA) a treatment, the new Act establishes a right for eHealth Solutions to be prescribed and reimbursed by insurance companies: providing start-ups with the opportunity to re-think and introduce new business models to support their growth.
Your Digital Health Solution – Eligible under DHA?However, not every digital health application will be eligible to become such a care treatment. Eligibility for insurance reimbursement is tied to strict criteria and eHealth Solutions will have to meet specific requirements in order to be recognized as DiGA under DHA, such as:
Insurance Reimbursement – The Fast Track ProcessNow to have their solution prescribed and reimbursed, makers of Digital Health Apps will have to undergo the “Fast Track Process” in order to be listed in the official DiGA directory. Precisely, they will have to apply to the competent authority and show that their products meet specific General Requirements (including those of GDPR and MDR) and will have “positive care effects”, not only for individuals, but also for medicine and the healthcare system itself.
The Fast Track Process: After a 3-months preliminary period for application review, the BfArM (which is the German Authority that reviews for DiGA applications) will approve temporarily (or not) the product for a 1-year testing period, during which the producers will have to demonstrate the “positive care effects” of their solution in order to be definitively listed in the DiGA directory.
What makes this process particularly interesting for digital health startups is that it is indeed very fast and allows for rapid business growth and evolution:
#3 Be the first among equals: conquer the new German digital Healthcare market in a heartbeatWhile the specifics are still in the process of being defined, interested companies can and should already look for eligibility to ensure that they will be the first to benefit among many more to come and compete with. We will never emphasize on this enough: Time matters.
So if you wish for your product to be part of the short-listed portfolio in the beginning of DiGAs era, now is the time to apply and place your solution at the top of German eHealth innovation.
Being first to last – requirementsDespite the easy appearance of the fast-track process, Digital Health innovators will have to work hard to see their Applications accepted (at least temporarily) by the German authorities. Since DiGAs are defined as GDPR and MDR compliant products, meeting the requirements of these regulations will certainly be the first challenges for achieving DiGA-recognition. However, this will only be the top of the iceberg. Producers will also have to strike the right balance between scalability and interoperability to ensure that their Apps thrive in the new German digital era.
German Healthcare 4.0 – issues to addressThriving in the 4.0 digital era will certainly not be a breeze for health startups and organizations. With an average of 10 visits per year to their physicians, Germany certainly makes a strong case for a digital makeover, but also raises concerns about privacy and security of the german data. Especially at a time when we are still learning that secured systems are far from being the norm in Germany, regardless of severe GDPR fines and regular cyberattacks over the medical industry.
On top of state-of-the art privacy, security and data protection standards, organizations will have to tackle scalability and interoperability challenges, which might take time to prepare for. The telematics infrastructure of the German healthcare system and the specifics of Gematik’s dedicated computer network should also be addressed. Moreover, data storage and access should be a top priority. Specifically: where to keep the data & how to share it when needed?
Original Article published by Pryv
The SpeechMED™ Enterprise Suite allows hospitals and other caregiving institutions to visually and audibly relay vital medical information to their patients, in the language of their choice, so that more patients can understand and comply with their care instructions, and medical mishaps that arise as a result of a poor communication can be easily avoided.
According to the National Action Plan Health Literacy 2018, in Germany, approximately every second individual has limited health literacy. People with limited health literacy find it difficult to find, understand, appraise, and apply health-related information.” Recognizing this need, Taylannas Inc., Captiva and Qnidos are introducing an award-winning system designed for patients, caregivers and their healthcare providers.
Patients need better education that is customized to their needs and mobility. Language, cultural and vision impairments can render printed education materials useless. SpeechMED™ provides customized instructions, a consistent and easy-to-use interface, language support, population analytics, and communication tools that result in reduced readmissions to the hospital and fewer medical mishaps due to miscommunication.
The language and audio platform allow patients and their caregivers to read and listen to their information in the language that they understand. The “Home” mobile application is designed to educate the patient, deliver care instructions, send medication reminders, store allergy lists, and keep emergency contact information in multiple languages. It also allows caregivers to monitor their family member’s activity remotely while they are at work.
In addition, SpeechMED’s easy to use platform facilitates the transition of care from a hospital to a caregiver by including a personalized assessment of the patient’s needs and a proactive care plan by allowing the patients or their caregivers to monitor and follow up on medications and appointments, and at the same time assists healthcare providers in continuing to monitor the patient’s health after discharge to home care.
Site Selection magazine has named Germany the world‘s best country to invest in, ahead of the United Kingdom and Australia. And Germany Trade & Invest (GTAI) was chosen as the second best national agency for international investment behind Ireland.
GTAI, Site Selection pointed out, posted a record of 2,062 foreign direct investment projects in 2018. According to a study carried out by Ernst & Young, investment in German startups rose by 36% year-on-year, reaching €6.2 billion euros in 2019.
“Amidst the corona crisis, it’s especially encouraging to get positive feedback from abroad about Germany as a business location,” said GTAI Head of Investor Consulting Achim Hartig. “For us, being again named Site Selection’s “#1 Overall Global Best to Invest Country” is an important signal for our agency and confirms our conviction that we were able to communicate Germany’s advantages at home and abroad.”
“We will continue to work through the corona crisis in Germany with humility and respect,” Hartig added. “We hope that this accolade is a good springboard in our efforts to show companies that in German their businesses are secure in times of crisis and will be able to develop resiliently in the future.”
Interested how you can benefit from launching your healthcare venture in Germany?
On March 14, 2019, the German Bundestag passed the Schedule Service and Supply Act ("Terminservice- und Versorgungsgesetz, TSVG"), generally aiming to improve service levels within the statutory health insurance system. Together with those regulations, the TSVG contains a set of rules that are of high interest for private equity investors active in the German healthcare sector.
The now approved rules and regulations affect the investment into medical supply centers ("Medizinische Versorgungszentren, MVZ"), via hospitals and non-medical dialysis suppliers which are the only inroads into the statutory health supply system available for—and, in fact, largely used by—sponsors (the others being nonprofit organizations and municipalities which by definition are no viable options for investors).
The new law states that the incorporation of an MVZ via a non-medical dialysis supplier shall only be applicable to an MVZ providing subject-related medical care (i.e., medical care in connection with dialysis services or overall care for renal patients), thus making these investment vehicles unavailable for the establishment of MVZs in other disciplines, such as ophthalmology or radiology.
Matthias Uibeleisen published an excellent article and update on this topic. You can download the PDF here as your weekend read.
Our team will be always available to answer all your pressing questions how this may impact your future decision making. You can schedule a call or email us your questions.
As a result of reforms by Health Minister Jens Spahn, new laws will come into force on 1. January 2019 in the areas of health and care.
On the one hand, the contribution to long-term care insurance will rise to 3.05 percent and for childless persons to 3.3 percent. At the same time, the contribution to statutory health insurance will again be divided equally between employers and employees as well as pensioners and pension insurance. This also includes the additional contribution of the health insurance funds, which was reduced by 0.1 percentage points to 0.9 percent in the new year.
On the other hand, hospitals must comply with lower limits for nursing staff in the areas of intensive care medicine, geriatrics, cardiology and accident surgery. In addition, 13,000 jobs will initially be created for nursing care in nursing homes, which will be paid for by the health insurance funds. In addition, each additional position in hospital care will be refinanced by the health insurance funds. The additional costs are also financed by the health insurance companies due to higher tariff agreements. In addition, standard wages for domestic nursing care must be accepted by the health insurance funds.
The new law is intended to make training places more attractive again. Starting in 2019, the remuneration of trainees in their first year of training will be completely covered by the health insurance funds. This applies to children's nursing, nursing and nursing assistance.
In order to make the nurse profession more interesting again, the working conditions are to be improved. In addition to better remuneration, this includes above all the compatibility of work and family life. To this end, nursing homes and hospitals are now being financially supported. In addition, the health insurance funds will have to raise an additional 70 million euros for workplace health promotion.
In order to promote digitization, the nursing insurance funds are releasing 12,000 euros per institution on a one-off basis.
From this year onwards, easier access to inpatient medical rehabilitation services will be guaranteed to relieve the burden on caring relatives. If the person in need of care is cared for in a rehabilitation facility, the health insurance funds will cover the costs.
Germany’s Human Genetic Examination Act exists at a paternalistic extreme of the spectrum with respect to the regulation of genetic services and information, sharing that space with the similarly restrictive Norwegian Biotechnology in Human Medicine Act (pdf), both of which seem influenced by the Council of Europe’s Convention on Human Rights and Biomedicine. Elsewhere on the spectrum, the most comprehensive piece of U.S. federal genetic legislation, the Genetic Information Nondiscrimination Act (GINA), restricts use of genetic information by insurers and employers but leaves individuals free to use genetic testing services as they choose. Similarly, in the United Kingdom, the recent and widely-discussed House of Lords Report on Genomic Medicine advises the DTC genetic testing industry to adopt a voluntary code of conduct for assessing the clinical utility of its services and the need for associated genetic counseling.
The German Act, on the other hand, adopts an extremely protective, even fearful, view of genetic information as something so dangerous and private that the generation and disclosure of genomic data must be mediated solely through specially trained physicians, accompanied by psychological and social counseling, and subject to destruction of the data at any time upon the request of the subject individual. In addition to tightly regulating the doctor/patient relationship, the Act appears intended to outlaw (or at least highly restrict) DTC genetic testing services. One of the laudable purposes of the act, “to protect human dignity and to ensure the individual right to self-determination via sufficient information,” is belied by provisions of the Act that restrict the ability of individuals to access their own genetic information directly.
Assuming the legislation is enacted, there will be plenty of international observers tracking the consequences of Germany’s attempt to tightly control its citizens’ access to and use of their genetic information. Will DTC companies cease sending spit kits to German residents? Will German citizens seek genetic testing in less restrictive climes? Will Germany’s example prompt other countries to follow a similar policy of genetic exceptionalism enforced by paternalistic regulation?
A recent study focused on the Digital Health Index and the index shows how much a country relies on digital technologies in its healthcare system by international standards. The result shows that Germany is lagging behind.
With an index of 30 on a scale of 1 to 100, Germany ranks 16th out of 17 countries surveyed. Only Poland is worse with an index of 28.5. Estonia places the highest emphasis on digital technologies (81.9), followed by Canada (74.7), Denmark (72.5), Israel (72.4), Spain (71.4) and NHS England (70.0). Australia (57.3), Italy (55.8), Belgium (54.7), Switzerland (40.6), France (31.6), Germany and Poland are below the average of 58.9.
The study points out that more emphasis should be placed on the potential of digital health solutions. For example, electronic patient records could prevent dangerous drug interactions, telemedicine could bring patients together with medical experts from any location, and health apps could strengthen chronically ill patients.
"While Germany is still exchanging information on paper and working on the fundamentals of digital networking, other countries are already taking the next steps," said Brigitte Mohn, CEO of the Bertelsmann Stiftung. "In Israel, for example, physicians are systematically using artificial intelligence - for early detection of cancer, for example. The demand from this realization is that health policy must act more decisively and further expand its leading role in shaping digitization for the benefit of patients.
Further recommendations for health policy makers are:
Establishment of a national competence centre:
The coordination of processes from a central location is crucial for successful digitisation. The competence centre should integrate existing institutions, interest groups, experts and users and be responsible for standardising digital applications and defining interfaces. It should be politically controlled and independent of actors' interests.
Step-by-step approach to developments
Individual treatment areas and processes should be targeted. "The expected improvement in care and possible efficiency gains should guide action.
Systematic inclusion of patients and physicians as users:
When developing partial strategies as well as digital applications and processes, users such as patients and doctors should be directly involved and not their professional representatives. The benefits of applications should be visible at an early stage.
Promoting general acceptance:
Digital change needs acceptance and a broadly shared vision. Politicians should understand and approach their communication to this effect as a strategic task.
A published representative population survey commissioned by the digital association Bitkom showed that there is a high level of acceptance for the digital healthcare system. More than two thirds of the respondents were in favor of the use of artificial intelligence in medicine and care.