News: DiGA & Medical Software

The publication of a revised version of IEC 62304 was originally expected in August 2026, but has been significantly delayed: Nearly 1,500 comments were received on the 2025 Committee Draft. So far, only the second Committee Draft has been released, which means the...

As of July 1, 2026, Phase I of the in-use performance measurement (AbEM) applies to all permanently listed digital health applications (DiGA). According to Section 23c(1) of the DiGAV, DiGA manufacturers must submit the following data for the third and fourth quarters...

Nearly three years after the last version, the BfArM has published Version 1.3 of the Guidelines for Digital Nursing Applications (DiPA). This means that the changes from the first DiPAV amendment have now been incorporated into the guidelines. The most important...

The German federal government has approved the draft of the Act on Data and Digital Innovation in Healthcare (GeDIG). It addresses nearly all areas relevant to digitalization, supports the national implementation of the European Health Data Space (EHDS), and is...

The European Commission has updated its list of standard fees charged by Notified Bodies (MDR/IVDR). It consolidates the fee schedules published by the individual Notified Bodies in one place. It’s worth taking a quick look for anyone comparing or budgeting for...

Following the Supreme Court’s ruling in Trump v. Slaughter ( June 29, 2026), the U.S. Federal Trade Commission (FTC) loses its independence: The court ruled, in accordance with the “unitary executive” doctrine, that the President’s authority to issue directives...

Parliament and the Council have given their final approval: For AI in medical devices, the high-risk requirements will be postponed from August 2, 2027, to August 2, 2028. For standalone high-risk AI, the obligations take effect on December 2, 2027; for AI used as a...

On June 23, 2026, France’s CNEDiMTS (part of the French Health Authority, HAS) issued a positive recommendation for Poppins Clinical from BMOTION Technologies. This marks the first time a true digital therapy has been covered through the PECAN reimbursement channel....

On May 4, 2026, the European Commission adopted Implementing Regulation (EU) 2026/977 (Official Journal of May 5, 2026). For the first time, uniform maximum time limits for conformity assessment by notified bodies are laid down across Europe. The new maximum time...

The DMP Subcommittee has begun updating the requirements for the DMP COPD and, among other things, has asked manufacturers’ associations to propose “suitable digital medical applications” as appropriate. The rules of procedure do not provide for an open application...

The German Digital Healthcare Association (SVDGV) has issued a sobering interim assessment of the new e-prescription process for digital health applications: Rather than making access easier, it is actually hindering it. Only 14 percent of digitally prescribed DiGA...

On May 28, 2026, the six-month transition period following the European Commission’s declaration of functionality dated November 27, 2025, ended. As of that date, the first four EUDAMED modules are mandatory for all market participants. These modules are Actor...

On May 8, 2026, Whoop announced a platform expansion that shifts the company from traditional fitness trackers toward clinical care. The announcement came one day after Google unveiled the Fitbit Air and is part of a trend in which consumer device providers are...

The MDCG published Revision 1 ofthe “Guidance on the Classification of Medical Devices.” However, it contains only structural and editorial changes, as well as updated decision trees to better illustrate the classification rules and new examples. You can find the new...

Apple has also responded to the requirements set forth in MDCG 2025-4,“Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms”: In the European Economic Area (EEA), the United Kingdom, and the United States, the product page...

Five years after the introduction of DiGA, usage continues to grow: By the end of 2025, approximately 1.6 million activation codes had been redeemed, including about 690,000 in 2025. In total, this corresponds to over 1.7 million cases of care. DiGA Figures at the End...

On March 26, 2026, the European Parliament adopted its position onthe “Digital Omnibus on AI.”Following the Council’s earlier adoption of its position, trilogue negotiations are now set to begin. One of the goals of the omnibus package is to reduce overlaps between...

In France, a digital therapy has been approved for reimbursement for the first time. The health authority HAS has given the “Joe” (Ludocare) app a positive evaluation, thereby paving the way for its inclusion in the standard reimbursement program under the LPPR. The...

The draft bill to stabilize statutory health insurance (GKV) premiums, which was approved by the Federal Cabinet on April 29, 2026, is a response to rising expenditures in the healthcare system and provides for a broad package of cost-containment measures that is...

On March 9, 2026, the Federal Ministry of Health published the draft bill for the First Ordinance Amending the Digital Care Applications Ordinance (DiPAV). The draft implements changes required by the Act on the Extension of Powers and Reduction of Bureaucracy in...

From July 1, 2027, Section 374a SGB V will require certain manufacturers of medical aids and implants to provide interoperable interfaces so that health data from their products can be transferred in standardised form to a DiGA listed in the DiGA directory. This...

The standard "Artificial Intelligence – Quality Management System for EU AI Act regulatory purposes" (prEN 18286) is currently available as a draft and is intended to help companies implement the requirements of the EU AI Act. Its focus is a quality management system...

The Regional Social Court of Schleswig-Holstein recently addressed interim legal protection in the context of including DiGA in the DiGA directory. The case arose from an application for provisional reinstatement of a DiGA that the BfArM had not permanently included...

The BSI TR-03185 "Secure Software Lifecycle" defines requirements for secure software development processes across the entire product lifecycle. It is relevant for DiGA manufacturers because of the obligations arising from the BSI guideline: anyone who can demonstrate...

On January 30, 2026, the EU Commission published Implementing Decision (EU) 2026/193, which lists 12 further harmonised standards under the Medical Device Regulation (MDR). Particularly relevant for manufacturers of medical device software is EN ISO...

On February 11, 2026, the German Federal Cabinet approved the AI Market Surveillance and Innovation Promotion Act (KI-MIG). The act governs the national implementation of the AI Act. At its core, the act defines the national supervisory structure: The Federal Network...

On February 11, 2026, the Federal Ministry of Health (BMG) published its further development of the digitalisation strategy for healthcare and long-term care. Three planned measures in particular are relevant for DiGA manufacturers and medical device companies:...

On January 29, 2026, the Second Ordinance Amending the Digital Health Applications Ordinance (DiGAV) was published in the Federal Law Gazette (BGBl. 2026 I No. 22). It has been in force since February 1, 2026. An overview of the key changes: Application-accompanying...

The efficiency requirement (Section 12 SGB V) obliges health insurers to provide services in a way that is objectively necessary, sufficient and economical, and that does not cause unnecessary costs. At the same time, services must not compromise the quality and...

The results of the ImplementDiGA project have been published after around three years of research and three consensus workshops. The article in the E-Health Monitor 2025 by McKinsey DACH contains 34 evidence-based recommendations on care with DiGA. The process behind...

The EU Commission provides a playground environment for EUDAMED in which the functionalities can be tested with dummy data. On December 12 last year, this test data was made public without any further warning. So far, this step has not been reversed. You may want to...

OpenAI is responding to the fact that many users seek advice on health topics from AI: ChatGPT Health has been unveiled. For now, the offering is intended for US users only, and even they still have to wait on a waiting list to be given access to the system. The...

From February 2, 2026, the new Quality Management System Regulation (QMSR) takes effect in the USA and replaces the previous FDA Quality System Regulation (21 CFR Part 820). With the QMSR, the FDA adopts ISO 13485:2016 "by reference" as the central framework for the...

At the start of the year, the FDA updated two guidance documents. Here is a brief overview of the key changes. a) General Wellness: Policy for Low Risk Devices In contrast to medical devices, the guidance defines general wellness products as products that meet the...

At the end of December, the MDCG published new guidance on post-market surveillance. MDCG 2025-10 sets out the requirements for post-market surveillance (PMS) systems under the MDR and IVDR in more detail and describes how manufacturers must systematically monitor the...

A new version of the DiGA guide (3.6) has been published. The update to reflect the legislative changes made since 2023, in particular from the Digital Act (DigiG) in March 2024, was long overdue. These are now reflected in the new version. The update is extensive....

The EU Commission has completed a targeted evaluation of the MDR and IVDR, on the basis of which a current amendment proposal has been published. Among other things, adjustments to the classification rules for medical device software are proposed. A concrete draft of...

The draft of the forthcoming international standard on the clinical evaluation of medical devices has been published on the ISO website. This starts the public commenting phase. ISO/DIS 18969 describes how clinical evaluations are to be carried out systematically...

The provider of the obesity app Oviva Direkt had appealed against a judgment of the Regional Court of Potsdam. The appeal has now been dismissed by the Higher Regional Court of Brandenburg. The background was a lawsuit by the Wettbewerbszentrale (German centre for...

In the model region of Hamburg and the surrounding area, gematik worked with medical practices, health insurers and software providers between May and September 2025 to test the e-prescription process for DiGA under real-world conditions for the first time....

From July 1, 2026, Swiss compulsory health insurance (OKP) will cover the costs of digital health applications for treating depression: Digital applications for cognitive behavioural therapy (CBT) for patients with mild to moderate depressive episodes and recurrent...

Under TR-03161, DiGA manufacturers must submit every planned update to the BSI for assessment. In current discussions, the BSI is bringing another technical guideline into play, published only in August of this year: TR-03185 Secure Software Lifecycle for Proprietary...

The gematik has decided to permit the "Nect ePass" video ident procedure again, officially since August 1, 2025. The procedure allows insured persons to verify their identity by video and biometric identity check in future, without having to use a PIN on their...

Google is updating its policy on health and medical apps and incorporating elements of MDCG guidance 2025-4 for medical devices under the MDR. In future, medical device apps in the Play Store will carry a "Medical Device" label, for example. The New Google Guidelines...

On November 26, 2025, the EU Commission published its decision on the mandatory use of the following EUDAMED modules: Registration of economic operators UDI database and device registration Systems for notified bodies and certificates System for market surveillance An...

Unlike DiGA, digital care applications (DiPA) have had a hard time so far: for want of successful approvals, the DiPA directory is still empty. The so-called BEEP Act (Act on the Extension of Powers and Reduction of Bureaucracy in Nursing Care) is intended to change...

The EU AI Act entered into force on August 1, 2024. The implementation obligations, however, take effect in stages. According to a recent Handelsblatt report, the European Commission plans in a first draft to significantly weaken central requirements. Specifically,...

Good news for medical device manufacturers: ISO 13485:2016 will remain unchanged for another five years. This means no major changes are to be expected to quality management systems that already comply. This was particularly important because the US authority FDA has...

The clinical evaluation of medical devices under the MDR is not based on a standard, but on various MDCG guidance documents and MEDDEV 2.7/1 rev. 4. In the past, this led to differing requirements from notified bodies and uncertainty on the manufacturers' side. ISO...

The European Commission's feedback round is already the second round in which various stakeholders can submit their feedback on the classification of software under the MDR. The first round mainly served to identify implementation problems, while the second round...

The European Court of Justice has ruled that telemedicine services provided by doctors may also be delivered across national borders. The case concerned an Austrian dentist who provided telemedical aftercare for dental aligners through the app of a German provider....

Under the AI Act, EU member states must provide a sandbox so that innovative AI systems can be safely tested for security and regulatory compliance in an isolated test environment. The Spitzenverband Digitale Gesundheitsversorgung (SVDGV) has published a green paper...

The implementation of BSI TR-03161, which is mandatory for DiGA, is causing considerable dissatisfaction among patients. Automatic logout from the app after inactivity or the complicated setup of two-factor authentication overwhelms many users, for example. One reason...

To date there is still not a single approved DiPA (digital care application). Unlike its counterpart DiGA (digital health application), it is therefore still far from reaching the everyday care of carers and those receiving care. A draft bill on the "Extension of...

The EU Commission has published the fourth update of the Borderline Manual on the classification of medical devices. For software, it brings no fundamental changes compared with the MDR and MDCG 2019-11. The manual does, however, contain examples that can be relevant...

In the field of wearables, there is an increasing shift from pure fitness tracking to fundamental health diagnostics. Blood pressure in particular is a parameter many manufacturers are focusing on. In the August newsletter we already reported on the manufacturer...

The success of a therapy depends not least on whether patients follow the recommendations for successful treatment. This is also true for DiGA. The research project "DEKODE" is investigating how various factors such as usability or a comprehensible introduction to...

The online magazine t3n reports on the digital health market segments currently driving growth in Germany. According to the report, the field of digital treatment and care (digital care management, for example) has grown to 2.5 billion euros. Directly behind it come...

33 digital health organisations have published a joint statement calling for an EU assessment framework for the reimbursement of digital medical devices. It should be set up as early as 2026. They criticise that separate national approaches lead to duplicate...

The manufacturer of the WHOOP fitness band offers, within a special subscription, the option of displaying an estimate of the diastolic and systolic values. According to the FDA, the two individual values amount to a blood pressure reading and are therefore suitable...

Deutsches Ärzteblatt reports repeated outages of the e-prescription system and the associated telematics infrastructure. On five days within two weeks, there were outages or significant disruptions. The Federal Union of German Associations of Pharmacists is calling on...

Clemens Doubrava, head of unit at the BSI, maintains a private directory of cloud service providers that state they hold a C5 attestation. The list is growing steadily and was last updated at the end of August: List of C5 attestations For DiGA, our QuickBird Medical...

In an article on DiGA, Apotheken Umschau addresses familiar points of criticism such as costs and prescription numbers, but draws an overall positive conclusion: for many people, DiGA are the only way to currently obtain fast, low-threshold care for widespread...

The Danish health authority has officially recommended 5 health apps for the first time. The aim is structured but low-threshold access to digital health applications, embedded in everyday care without an immediate overhaul of the system. The basis for this is a...

Since April 1, 2025, doctors and psychotherapists have been allowed to conduct up to 50% of their treatment cases per quarter exclusively by video consultation, with the previous distinction between known and unknown patients abolished. The SVDGV, among others, sees...

From December 2024 to March 2025, the EU Commission gave a broad group of stakeholders the opportunity to provide "feedback on the effectiveness, efficiency, relevance, coherence and EU added value of the regulations on medical devices". The regulations concerned were...

As of today, ORIKO® is officially listed by the BfArM as the first DiGA for adults with ADHD and is being added to the DiGA directory. QuickBird Medical handled the technical, regulatory-compliant development of ORIKO®, on behalf of the client MiNDNET Solutions and in...

Anyone wanting to either keep a DiGA in the directory or have one newly listed since January 1, 2025 needs the certificate under BSI TR-03161. The extended grace period for manufacturers to submit it now ends on June 30. The big question: what happens to those DiGA...

MDCG 2019-11: Qualification and classification of software The MDCG has revised its guidance on the qualification of software as a medical device (MDCG 2019-11). The key changes at a glance: The new version stresses the great importance of a clear intended purpose as...

Handelsblatt summarises a study by Strategy& (part of the PwC group). It is titled "AI's 868 billion healthcare revolution". It forecasts that the market for products with integrated AI will grow above all in the area of AI-supported business models and through...

Using AI tools is becoming a habit for more and more people, including in healthcare. The main problem here is the use of private user accounts that are not provided by the employer. Yet according to an article in Handelsblatt, this appears to be happening more and...

Since March 2023, DiGA can be approved via the French PECAN procedure in a kind of fast track. They are then provisionally reimbursed by the health insurers. Full proof of clinical effectiveness must then be presented at the end of this period for the DiGA to be...

Researchers at FAU Erlangen-Nürnberg criticise, in a publication, the methodology used in approval studies for DiGA. They are meeting opposition from several quarters, however. According to the analysis, approval studies for DiGA sometimes show considerable...

A survey of the 20 largest private health insurers by the "Inside Digital Health" desk at Handelsblatt found that only very few of them plan to provide an electronic patient record (ePA) for their policyholders in 2025. The reasons for this are varied and partly...

The current VC funding report by Pulsewave reports strong funding rounds in the first quarter of 2025. In total, 101 deals were closed with a total volume of 1.44 billion euros. Of this, according to the report, 342 million euros is attributable to the 18 German deals...

On May 21, the BSI updated its FAQ on TR-03161. It now lists different authentication methods for DiGA that are permissible within TR certification, for example. It also distinguishes which methods count as "suitably secure" and which methods require consent from the...

At its meeting on April 30, 2025, the Swiss Federal Council adopted new guidelines intended to allow the approval of medical devices from non-European regulatory systems, such as the US Food and Drug Administration (FDA), in Switzerland. Until now, Switzerland has...

It is now settled: from April 29, the ePA can be used throughout Germany. After the trial in the test regions had been completed, the then health minister Lauterbach was still vague, but on April 15 the shareholders of gematik received a letter from the Ministry of...

The Federal Joint Committee (G-BA) has adopted new rules for disease management programmes (DMP) aimed at greater digitalisation and more flexibility in the programmes. Specifically, digital applications and telemedicine offerings are to be integrated better into the...

Handelsblatt reported in its digital health newsletter at the beginning of April: the online dermatology practice Dermanostic has received certification as a class IIa medical device. Behind this formal recognition, however, lies a longer dispute with the competitor...

The Trump administration in the USA is currently having many effects inside and outside the United States. The future of many institutions and agreements is uncertain. This includes the Data Privacy Framework (DPF). The DPF is a mechanism for facilitating the transfer...

Alongside the rollout of the ePA, there is another milestone in the digitalisation of health data: the Regulation on the European Health Data Space (EHDS) already entered into force on March 25. The transition phase now begins. However, the EU will not determine how...

The manufacturer Lindera developed an app for fall prevention in people in need of care. Its application for inclusion in the DiPA directory for so-called digital care applications failed at the BfArM, however. The DiPA directory, the counterpart to the DiGA...

There is good news in the DiGA field: According to information from Handelsblatt, HelloBetter of Berlin can use funding of more than 6 million euros to expand internationally and bring AI-supported products to market. According to the company, its goal for 2025 is to...

The German Association of Healthcare IT Vendors (bvitg) published its healthcare IT trend report at the beginning of March. An entire chapter is devoted to the use of AI in healthcare. According to it, a quarter of respondents in Germany believe their health will...

Ärzteblatt reports on a decision by the Regional Social Court of Berlin-Brandenburg (case no. L 4 KR 196/23 KL). It confirms the authority of the arbitration board in deciding DiGA prices. DiGA manufacturers negotiate the permanently reimbursed price with the National...

Great news from Belgium: seven telemonitoring applications reached the highest level of the mHealthBelgium validation pyramid (level 3+) in February 2025. This means the apps can be reimbursed on a regular basis by the Belgian health insurance system (INAMI/RIZIV) as...

Amazon Web Services (AWS), Hetzner, IONOS, Telekom Cloud, and others—(aspiring) DiGA providers have a wide range of options when it comes to choosing a hosting service provider. This leaves them facing a difficult decision: Which server provider is the right one? To...

The second application for reimbursement under PECAN to date has been rejected in France. The reasons given for the rejection are as follows: Proof of clinical benefit was provided solely on the basis of a literature review. Its data, however, comes mainly from the...

IEC 62304, the standard for the software development lifecycle for medical device software, is to be revised. According to the website of the British Standards Institution, the current draft has been completed and was open for public comment until February 12, 2025....

The AI Act is entering into force in stages: since February 2, the use of prohibited practices has been ruled out. What exactly these prohibited practices are is explained by the EU Commission across 140 pages of guidelines. If you are interested in the AI Act, also...

Regenold and Sträter Rechtsanwälte report on LinkedIn on a decision by the Higher Regional Court of Hamburg: the revised dermatology app dermanostic no longer falls under the distribution ban imposed on it. Back in June, the court ruled that dermanostic may not...

In March 2024, the European Court of Justice ruled that harmonised technical standards are to be regarded as part of EU law and must therefore be available to view free of charge for companies and private individuals. One part of the reasoning was that this is the...

The International Medical Device Regulators Forum (IMDRF) is a voluntary association of medical device regulators from around the world. At the end of January, the IMDRF published a practical guidance document on classifying risks in software medical devices. The...

Digital care applications (DiPA) were intended by the legislator as the equivalent of DiGA in the care sector. They are meant to support the everyday lives of people in need of care and those around them through web and smartphone apps. So far, however, they have not...

The telemonitoring application CardioCare@Home by Byteflies has reached the highest validation level (level 3+) for DiGA in Belgium and can be permanently reimbursed with immediate effect. It is therefore the second digital application at this level. CardioCare@Home...

Cara Care has been added to Bayer's portfolio as its first DiGA: at the start of 2025, the group is acquiring HiDoc Technologies, the company behind the DiGA. For people with irritable bowel syndrome, the app offers personalised therapy support through nutrition...

After Cureety in 2023, Axomove is now the second application to be added by the health authority to the directory of reimbursable digital health applications in France. Axomove is a telemonitoring application intended to improve the rehabilitation and prevention of...

At the Austrian LiSA Vienna conference, the plans known so far for DiGA in Austria were reaffirmed. According to these, DiGA are to be available to Austrian insured persons from 2026. As a first step, an assessment procedure for DiGA is to emerge from the current...

In our September newsletter we reported on the draft of the Nursing Competence Act (PKG), which is also intended to give DiPA a boost. By introducing a trial year, increasing the financial entitlement and allowing the effectiveness of DiPA to be demonstrated through...

After Apple's AirPods Pro 2, there is now a second consumer product that has received medical functionality with FDA approval in addition to its other applications: Google's FitBit has an integrated infrared sensor for measuring body temperature, which has been...

The gematik commissioned the Fraunhofer Institute SIT to independently examine the security concept of the electronic patient record (ePA). This review was carried out voluntarily, even though it is not required by law. Overall, the system architecture of the ePA was...

In October 2024, the first bilateral meeting between Germany and France on the scientific assessment of digital medical devices took place in Strasbourg. The French National Health Authority (HAS) and the German Federal Institute for Drugs and Medical Devices (BfArM),...

The Federal Ministry of Health is planning a new act for better care of people in need of nursing care: the Nursing Competence Act (PKG). It also draws on DiPA, the digital care applications. On September 6, 2024, the draft bill for the Nursing Competence Act was...

It was heavily criticised from many quarters: the Healthy Heart Act. The reallocation of funds away from the prevention of cardiovascular disease in favour of medication in particular has come under fire. Changes are now planned that are intended to strengthen the use...

The Spitzenverband Digitale Gesundheitsversorgung criticises the current draft for prescribing DiGA via the e-prescription, because it creates barriers to access and makes care more difficult for patients. The gematik draft provides for the activation code needed to...

With OnlineDoctor 24 and Dermanostic, two providers of digital dermatology services have for some time been fighting a legal dispute over the correct risk classification under the MDR. After an earlier decision to the contrary, a new judgment has now been handed down...

The rules on the C5 attestation from the DigiG are relevant not only for DiGA manufacturers: According to SGB V, they affect all "service providers within the meaning of the fourth chapter and health and long-term care insurance funds as well as their respective data...

The German Medical Association, the Federal Chamber of Psychotherapists, the Association of Private Health Insurers and the public sector benefit offices have published new recommendations for billing psychotherapeutic services: Since July 1, 2024, psychotherapists...

In a detailed whitepaper on the subject of digital health applications, the digital industry association Bitkom has looked at the question of which challenges DiGA need to overcome to break through into standard care. Bitkom summarises its policy demands on page 22 of...

In Austria, the e-health strategy 2024-2030 has been published, setting out key goals for implementing the overarching principle of "digital before outpatient before inpatient" in the digitalisation of Austrian healthcare. One of the goals it contains is the "creation...

On July 12, 2024, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (the AI Act) was published in the Official Journal of the European Union. It enters into force twenty days after publication. Some rules, such as the ban on AI systems...

On May 21, 2024, the EU Council finally adopted the AI Act. For manufacturers of medical software with AI, transition periods for implementation now apply, depending on the risk class defined in the AI Act. Approaches to implementing AI in medical devices are already...

The Technology and Methods Platform for Networked Medical Research (TMF) has published current survey results on the use of health data for research without consent, as also provided for in the GDNG (Health Data Use Act): The GDNG provides for patient data to be...

The BSI has provided an assessment specification that makes it possible for health insurers to offer the e-prescription function in their own app. To do so, they must obtain a security assessment confirming compliance with that specification. This assessment must then...

The Medical Device Regulation (MDR) is slowly but surely replacing the previously applicable Medical Device Directive (MDD). Provided manufacturers meet various criteria (for example, having submitted a transition plan by May 26, 2024), the deadline is extended,...

Since March 2023, the French government's decision to create a uniform procedure for the recognition and reimbursement of digital health applications has been in place. Now it is also clear what amounts DiGA manufacturers can calculate with in France. The following...

The BfArM has published updated data protection criteria for DiGA and DiPA. In principle, manufacturers are to demonstrate compliance with the data protection criteria from August 1, 2024 by presenting a certificate. The BfArM points out, however, that there are...

TK, Germany's largest health insurer by membership, has published its second DiGA report (after 2022). For the first time, TK includes the outpatient care history of DiGA users in the 24 months before they used a DiGA. This is an approximate description of the care...

The European Union relies increasingly on technical standards for harmonisation in the single market. A landmark decision by the European Court of Justice (ECJ) has now been handed down on this: the technical standards concerned must be accessible free of charge to...

According to the BfArM, there is a lively exchange with representatives of various countries about German experiences with DiGA. Alongside the exchange about projects, there are also many informal conversations. The prescription figures for German DiGA, which still...

DiGA are increasingly finding a firm place in the prescribing practice of GPs. Other groups of doctors are also valuing their use more and more. This is the conclusion of an online survey by Stiftung Gesundheit among GPs, specialists, dentists and psychological...

Citing the increased interest in AI applications, the European Union's so-called "AI Act" is intended to clarify what AI software may and may not do, what obligations companies have and what requirements products must meet. The AI Act (AIA for short) is part of the AI...

In December 2023, the FDA is carrying out an update of 21 CFR 820 (Quality System Regulation) to align it with the specifications of ISO 13485:2016. The aim of this revision is to promote more advanced risk management principles while at the same time reducing the...