4PM Ventures

4PM Ventures 4PM Ventures - European Healthtech venture Builder
We are creating the future of healthcare

EXPANSE Capital is a technological BOUTIQUE START-UP ACCELERATOR for science-intensive projects headquartered in Riga (Latvia) specializing in Life Science: BioMedTech, Digital Health, AgroTech, Techbio, Femtech, etc. Today we are interested in startups incorporated in Eastern Europe, or those that want to move their headquarters to Latvia in the following areas:
- Digital Therapeutics;
- Persona

l Medical Assistant - medical devices;
- Home based rehabilitation - rehabtech
- Technologies for health diagnosis;
- Hospital at Home (Home Healthcare);
- Femtech - describes technology that focuses on women's health. The founders of the company have a combined experience in the venture capital industry for more than 25 years, including work on bringing technology startups to the markets of Europe, the USA and Asia. The expertise of the founders of the company covers the areas of international marketing, corporate law, product creation and development, building global companies and selling them to corporations. Currently, we are interested in and open to cooperation with manufacturers of medical equipment, pharmaceutical companies, and medical institutions (clinics and rehabilitation centers). A wide and up-to-date network of partnerships in the field of venture investments and business development allows us to find optimal solutions for each of our clients, both for start-ups and corporations. Today, the technology boutique-accelerator Ехpanse Capital is developing as a European accelerator 3 in 1 (three in one): seed fund - accelerator - startup studio (venture builder) with a basic business model - Sweat equity, that is, the accelerator's income from the capitalization of portfolio startups in which the services and competencies of the accelerator are invested. A startup can begin cooperating with us at any time, since we do not make selections for our programs, but in order to cooperate with us, we help startups to incorporate in Latvia, Spain, Switzerland, Cyprus and develop in the EU, Middle East, Latin America markets. We actively cooperate with corporations and universities to accelerate startups and jointly develop innovative ecosystems.

💊 Number of the Day — $2.1BThat’s how much Isomorphic Labs — an AI-biotech company and DeepMind spinout — has raised to ...
13/05/2026

💊 Number of the Day — $2.1B

That’s how much Isomorphic Labs — an AI-biotech company and DeepMind spinout — has raised to accelerate AI-driven drug discovery.

The round became one of the largest in AI for Healthcare, signaling that the market is betting not only on LLMs, but also on AI-powered pharmaceutical innovation.

The company’s next milestone is to bring AI-designed drugs into clinical trials by the end of 2026.

For the pharmaceutical industry, this is another strong signal: AI is evolving from an optimization tool into a core platform for creating new products and transforming R&D.

The 4PM Ventures team invites pharmaceutical companies to collaborate.

We can support you with:
— technology scouting and identification of promising AI/biotech solutions
— access to international innovation ecosystems
— attracting external funding and co-financing innovation projects
— development of new digital services
— solutions to improve operational efficiency and accelerate innovation

We are especially interested in companies working at the intersection of:
🧬 AI + Drug Discovery
📊 AI + Clinical Development
⚙️ AI + Pharma Operations
🩺 Digital Health & Preventive Care

We would be happy to connect and explore partnership opportunities.

We analyzed the latest research from Endeavor: "Where Do Unicorns Come From?" - exploring how and where unicorn founders...
08/05/2026

We analyzed the latest research from Endeavor: "Where Do Unicorns Come From?" - exploring how and where unicorn founders emerge.

And we would like to highlight several conclusions that we believe are critically important for the development of HealthTech ecosystems in Europe and beyond.

The main conclusion of the research:
unicorns do not emerge by accident.

They are created inside strong entrepreneurial ecosystems where there is continuous interaction between:

* entrepreneurs,
* investors,
* universities,
* corporations,
* healthcare institutions,
* international markets.

The research shows:

🔹 founders are developed inside startup and scaleup environments — not only within elite universities;

🔹 one successful startup creates a multiplier effect — generating new founders, investors, mentors, and companies;

🔹 international exposure, mobility, and cross-border integration are critical drivers of strong innovation ecosystems;

🔹 the next generation of unicorns will not be isolated products, but platforms and infrastructure players solving systemic healthcare challenges.

These are exactly the principles around which 4PM Ventures is building its model.

We believe the future of healthcare will not be created by standalone startups, but by ecosystems, platforms, and new models of collaboration between market participants.

That is why 4PM Ventures focuses on:

* venture building,
* platform approach,
* ecosystem orchestration,
* startup relocation,
* cross-border innovation development,
* corporate venture building.

Our goal is not simply to invest in startups, but to build the infrastructure for the creation of new companies, platforms, and future healthcare unicorns.

HealthTech remains one of the most challenging industries:
regulation, clinical validation, long commercialization cycles, and the high cost of mistakes mean that most startups do not survive.

We are building a system to reduce this risk through:

* venture building,
* acceleration,
* ecosystem integration,
* corporate partnerships,
* international integration.

Today, 4PM Ventures is open to relocation from Latvia to countries and regions interested in developing HealthTech ecosystems, and is looking for strategic partners and investors ready to jointly build innovation infrastructure and transform healthcare markets.

We believe:
the future of healthcare will not be built by individual companies.

It will be built by ecosystems.

Endeavor Insight studied the career journeys of founders from the top $1+ billion companies in emerging markets and the United States.

The Friday journey continues!We continue our Friday series where we review and announce studies that we find interesting...
08/05/2026

The Friday journey continues!

We continue our Friday series where we review and announce studies that we find interesting and that we recommend investors and founders pay attention to. Today, we will be providing an overview of the report "Disciplined transformation in an AI-enabled value-based market" published by KPMG.

Deal volumes dropped overall last year, with life sciences transactions falling from 924 to 813 and healthcare deals from 846 to 811. The fourth quarter was especially slow. That said, not every area struggled. Healthcare services remained the most active subsector, largely because the move to lower-cost care settings continued to accelerate. Healthcare IT also had a strong year, with deal volume hitting a four-year high as hospitals, insurers, and investors looked for digital tools to manage costs and improve efficiency. Hospitals and health systems had the toughest year, with only 46 deals announced or closed, down from over 100 in each of the previous five years.

Medical device companies spent much of 2025 reshaping their portfolios toward faster-growing areas like cardiology, ophthalmology, and oncology. AI in radiology expanded rapidly, with over 100 new FDA-approved algorithms in the first half of the year. The largest deal was Blackstone and TPG taking Hologic private for more than $18.3 billion. Pricing pressure was the top concern, with 67% of survey respondents saying the inability to pass along cost increases was their biggest challenge. Tariffs are an added worry, with one estimate suggesting 75% of medical devices sold in the US could face new tariffs in 2026.

Hospitals and health systems are under serious pressure. Research cited in the report found that about one-third of rural hospitals, more than 700 in total, are at risk of closure. The shift to outpatient care continues to reshape the industry, with outpatient volumes projected to rise 18% over the next decade compared to just 5% for inpatient stays.

Healthcare services had 439 deals through mid-December. Large drug distributors made significant moves: McKesson invested billions in cancer care services, Cardinal Health bought major stakes in urology and gastroenterology practices, Cencora closed a $4.4 billion acquisition. Behavioral health continued to attract strong interest, though reimbursement uncertainty is growing.

Healthcare payers completed only 71 deals as rising medical costs and higher than expected use of services forced insurers to rethink strategies. Many chose joint ventures over full acquisitions. Regulatory scrutiny remains high. AI adoption is growing but cautious. More than 85% of respondents expect to use generative AI in back office functions in 2026, but states like California have already banned insurers from using AI to deny coverage.

Healthcare IT was the best performing subsector. Deal volume hit a four-year high, up 14% from 2024. The American Medical Association found that two-thirds of physicians used health AI in 2024, up from less than one in four in 2023. Major tech companies like Microsoft, Alphabet, and Nvidia have invested hundreds of billions in AI relevant to healthcare.

Looking ahead to 2026, 67% of survey respondents expect deal volume to increase. Only 5% expect fewer transactions. The top concern is the future performance of target companies, followed by competition for a limited number of high-value assets and high valuations.

Our Venture Builder is looking for projects in the digital health market and is ready to help founders develop them. If you have such a project, please send your investment deck to us [email protected]

Our section: Go Global Strategies.The 4PM Ventures team helps startups enter new markets by developing growth strategies...
06/05/2026

Our section: Go Global Strategies.

The 4PM Ventures team helps startups enter new markets by developing growth strategies. As part of developing these strategies, we showcase various approaches and tools used in the market. One such tool is acquiring a local player with an existing customer base and a team that understands the local market. Here's an example of this approach in use.

Why does a startup need such a development and market entry strategy, you ask? A well-developed strategy, including selecting a company to acquire for market entry, simplifies and accelerates the process of raising investment.

The French scaleup says plans to hire 150 people and open a R&D centre in London

PitchBook Analyst Note: AI Will Deliver Care to Billions and Break the System That Built ItHot take: AI is not going to ...
05/05/2026

PitchBook Analyst Note: AI Will Deliver Care to Billions and Break the System That Built It

Hot take: AI is not going to “fix” or even “break” healthcare.
👉 It will expose how broken the data layer already is.

And one more thing - the framing of the key question is off.

It’s not about **who will pay** for AI in healthcare.
👉 It’s about **who will invest first**.

Everyone is talking about AI agents delivering care to billions.
But almost no one is asking a basic question:

What data are these systems actually trained on?

Right now:

* most datasets are **retrospective** (not real-time, not decision-grade);
* data labeling and clinical validation** are inconsistent;
* data supply is concentrated** in a few large players;
* and **data provenance / legality** is often a grey zone.

👉 That’s not a scaling problem. That’s a **foundation problem**.

Let’s be honest:

Outside of radiology (MRI, CT, imaging), there are very few truly high-quality, scalable medical datasets.

So we’re building AI on top of:

* fragmented data;
* biased samples;
* and unclear legal ground.

My contrarian view:
The next wave of value in healthcare AI won’t be captured by model builders.

👉 It will be captured by those who:

* control data access;
* structure and validate datasets;
* and build the infrastructure layer.

Which also means:

* clinics will need to become "data producers"
→ new revenue stream, but requires investment in IT infrastructure;

* platforms like "HEALDEX" will emerge as data exchange layers
→ connecting data providers with AI developers;

* capital will continue flowing into AI startups,
but only those with privileged data access will win.

* new risk / financing layers will appear
→ de-risking AI deployment and liability in healthcare.

If AI really scales to billions, as suggested —
the current system won’t break because of AI.

👉 It will break because it was never designed to handle data at that scale.

Curious to hear:
Do you believe healthcare AI is a model problem or a data problem?



81% of US physicians now use AI. We map a five-layer AI care delivery stack, profile dozens of companies, and project healthcare cost scenarios.

This Friday’s story kicks off now.We continue our Friday series where we review and announce studies that we find intere...
01/05/2026

This Friday’s story kicks off now.

We continue our Friday series where we review and announce studies that we find interesting and that we recommend investors and founders pay attention to. Today, we will be providing an overview of the report “Towards identifying good practices in the assessment of digital medical devices” by OECD.

Digital medical devices are evolving faster than the methods used to assess them. Unlike pharmaceuticals, these tools face rapid software update cycles, a volatile market where products can appear and disappear quickly, and unique technical considerations such as data privacy, cybersecurity, interoperability, and patient usability. Traditional HTA was not designed for this environment, and all six countries are experimenting with new approaches.

Germany has the most mature system. Since 2020, its DiGA fast-track pathway has allowed low‑risk, patient‑facing digital health applications to enter the statutory health insurance system. By October 2024, sixty‑five DiGA had been added to the directory, some permanently and others provisionally for twelve months while further evidence is generated. Between September 2020 and September 2023, more than 374,000 activation codes were redeemed by patients, and the system spent 113 million euros. Nearly half of all DiGA target mental and behavioural health conditions, offering app‑based cognitive behavioural therapy for depression, anxiety, panic disorder, and agoraphobia. Interestingly, only five percent of DiGA introduced in 2023 received permanent approval from the outset.

France introduced a new system in 2023. The PECAN pathway provides temporary reimbursement for up to one year for promising digital therapeutic devices and remote monitoring tools while further evidence is generated. By October 2024, six technologies had passed through this fast‑track pathway, including one digital therapeutic for mental health.

The United Kingdom has taken a different approach with its Early Value Assessment pathway. Rather than evaluating one technology at a time, NICE first defines priority clinical topics that matter to the NHS and then reviews multiple technologies addressing the same need in a single multi‑technology appraisal. In 2023-2025 more than one hundred digital technologies were evaluated, with each assessment covering between three and fourteen products.

Spain published a dedicated HTA methodological framework for digital health technologies in December 2023. It covers traditional areas such as safety, clinical effectiveness, and economic aspects, but also includes technical domains like interoperability, scalability, and data integration, as well as ethical considerations such as user autonomy, accountability, transparency, and explainability. Spain’s HTA network, RedETS, has begun national‑level evaluations using this new framework, but at the time of the report no digital health application or telemonitoring service had yet been included in the national Common Benefit Package.

Israel offers a different model. The Ministry of Health has extensive experience evaluating hundreds of digital health technologies through grant programmes rather than through the formal HTA pathway. These programmes support early research and development, piloting, and deployment. The Ministry of Health has co‑funded over seventy pilots and more than three hundred digital health service development and implementation projects.

Our Venture Builder is looking for projects in the digital health market and is ready to help founders develop them. If you have such a project, please send your investment deck to us [email protected]

Keeping the Friday vibe alive with our series!We continue our Friday series where we review and announce studies that we...
24/04/2026

Keeping the Friday vibe alive with our series!
We continue our Friday series where we review and announce studies that we find interesting and that we recommend investors and founders pay attention to. Today, we will be providing an overview of the report “Artificial intelligence is reshaping health systems: state of readiness across the European Union” published by WHO.

Starting with national strategies, only 3 EU Member States – Finland, Slovakia, and Sweden – have adopted a dedicated AI strategy specifically for the health sector. A further 4 countries are developing one, but the vast majority of nations have chosen instead to include health within broader cross‑sectoral AI strategies or national digital health plans. While 85% of EU Member States now have a cross‑sectoral AI strategy in place, many of these strategies remain in early stages of revision or lack a clear definition of what an AI system actually is. Oversight is equally fragmented, with most countries relying on multiple agencies or existing government bodies rather than creating new, independent entities to guide AI in health.

81% of EU Member States have consulted relevant groups on AI in health, most often through expert focus groups or informal workshops. Government actors, health care providers, and academic institutions are almost always at the table. Yet patient associations are consulted far less frequently, and the broader public is included in only four countries: Denmark, Estonia, France, and the Netherlands. Public hearings remain the least used method of engagement. Worse still, only a quarter of Member States have made the insights from their stakeholder consultations publicly available, which undermines transparency and public trust.

The health workforce is equally unprepared. Only 26% of EU Member States offer in‑service AI training for health professionals, and just 22% provide pre‑service training. Only 4 countries – Belgium, Denmark, Estonia, and Finland – offer both. When training does occur, it almost always reaches doctors, but nurses, administrators, and researchers are included far less often.

The legal and regulatory landscape is evolving but remains deeply uneven. Only 2 Member States – France and Italy – have issued health‑specific ethical guidelines for AI, and 11 countries have issued no ethical guidelines at all, nor do they plan to. Most countries are still assessing gaps in existing laws rather than creating new, dedicated AI legislation for the health sector. On liability, only 3 countries are developing specific legal standards for when AI systems cause harm; the majority are simply waiting to align with upcoming EU legislation. Alarmingly, while generative AI systems are known to have a significant environmental footprint due to high energy and water consumption, no EU Member State rated environmental impact as a major barrier to AI adoption, and 41% said it had no importance at all. Over half of Member States have regulatory agencies responsible for approving AI systems for health, but far fewer have agencies that monitor what happens after those systems are deployed in real clinical settings.

Turning to actual AI applications, the report finds that AI‑assisted diagnostics is the most common use, deployed in 74% of EU Member States, with 41% considering it fully established. This includes radiology, dermatology, and ophthalmology, where AI tools are already enhancing imaging and detection. Conversational chatbots for patient assistance come second, used by sixty‑three percent of countries, followed by automation of logistics and administrative tasks, which is active in fifty‑nine percent of Member States. Less common but growing areas include AI‑assisted prognosis prediction, surgery robotics, remote patient monitoring, and symptom checkers. Countries such as Austria, Czechia, Finland, France, Italy, Poland, and Spain are piloting or using all seven categories of AI applications.

On barriers, financial affordability is the most frequently cited obstacle, rated as being of major importance by 41percent of EU Member States. Legal uncertainty, data quality and standards, capacity gaps, lack of clear strategy, slow product approval processes, and insufficient evidence each follow at around twenty‑six to thirty‑three percent. Interestingly, legal uncertainty is a much smaller barrier in the EU than in the wider WHO European Region, likely because the EU’s AI Act and GDPR are providing a stabilising regulatory anchor. Trust and cultural impact are seen as moderately important across the board, but job displacement is considered a major concern only by Cyprus, Greece, and Italy. Most striking of all, environmental impact is not considered a major barrier by any single EU Member State, and four out of ten countries say it has no importance whatsoever – a dangerous blind spot given the well‑documented carbon and water footprint of large AI models.

When asked about policy enablers that would accelerate safe AI adoption, EU Member States spoke clearly. The single most valued measure is guidance on transparency, verifiability, and explainability of AI solutions to ensure trust in outcomes, rated as having a major positive impact by sixty‑three percent of countries. Almost equally important are accountability and liability rules for manufacturers, deployers, and users, as well as legal clarification on secondary use of health data and certification of AI systems, each rated as highly impactful by fifty‑six percent of Member States. Clarification on privacy and data protection rules for AI followed at forty‑four percent, and guidance on ethical development at forty‑one percent. Notably, no policy enabler was rated as having no positive impact, underscoring the strong consensus that deliberate, well‑designed policy is essential to making AI work safely in health care.

Our Venture Builder is looking for projects in the digital health market and is ready to help founders develop them. If you have such a project, please send your investment deck to us [email protected]

For founders entering the European market, choosing the right legal structure from the outset can have long-term implica...
23/04/2026

For founders entering the European market, choosing the right legal structure from the outset can have long-term implications. The company form selected at incorporation will influence governance, taxation, fundraising potential, and day-to-day operations.
In recent years, the Dutch BV (Besloten Vennootschap) has become an increasingly popular structure among startups, especially those with international ambitions. This reflects not only the strengths of the Dutch legal system but also the growing demand for flexible, scalable, and investor-ready frameworks.

4PM Ventures and our portfolio company HEALDEX (A platform for connecting data providers and data users) are also considering relocating from Latvia and exploring various options, including Luxembourg and the Netherlands. If you're an investor from these regions, I'd be happy to meet with you, send you our investment proposal, and discuss possible collaboration.

For founders entering the European market, choosing the right legal structure from the outset can have long-term implications. The company form selected at incorporation will influence governance, taxation, fundraising potential, and day-to-day operations.
In recent years, the Dutch BV (Besloten Vennootschap) has become an increasingly popular structure among startups, especially those with international ambitions. This reflects not only the strengths of the Dutch legal system but also the growing demand for flexible, scalable, and investor-ready frameworks.

4PM Ventures and our portfolio company HEALDEX (A platform for connecting data providers and data users) are also considering relocating from Latvia and exploring various options, including Luxembourg and the Netherlands. If you're an investor from these regions, I'd be happy to meet with you, send you our investment proposal, and discuss possible collaboration.

For founders entering the European market, choosing the right legal structure from the outset can have long-term implications. The company form selected

Friday is here, and so is your favorite series!  We continue our Friday series where we review and announce studies that...
17/04/2026

Friday is here, and so is your favorite series!

We continue our Friday series where we review and announce studies that we find interesting and that we recommend investors and founders pay attention to.
Today, we will be providing an overview of the report “Exploring Europe’s Digital Health Landscape: Market Dynamics and Economic Impact” published by European Commission.

The EU digital health market is set to grow from €11 billion in 2023 to €61.2 billion by 2035, growing about 15 percent each year. Most hospitals and clinics already use electronic health records and medical imaging systems, and nearly two thirds plan to upgrade these tools within the next four years. Artificial intelligence has become a main focus across the sector, with 94 percent of healthcare providers either using AI or planning to invest in it. The most common uses for AI are clinical decision support, early diagnosis, and remote patient monitoring.

Despite these bright spots, Europe is falling behind the rest of the world. Between 2019 and 2024, the United States took 81 percent of all global digital health investment, while the EU got only 7 percent. The United States has 354 digital health companies, nearly double the 196 based across all of Europe.

There are many barriers holding back adoption of technologies. On the healthcare provider side, 45% say poor interoperability and outdated IT systems are major problems. 48% say they do not have enough funding, even though they see the long‑term benefits. 34% struggle with a lack of digital skills among their staff, and 20% face resistance to change from employees.

Experts interviewed for the report said that overworked clinical staff simply do not have the time or energy to learn new systems without proper support. On the company side, 50% of digital health vendors say dealing with regulations is a top challenge. They have to navigate the Medical Device Regulation, the GDPR, the upcoming European Health Data Space, and the AI Act, all at once.

Looking at new technologies, the report gives a clear picture of where things stand. AI‑powered diagnostic tools are the most mature, with 28% of providers already using them and adoption expected to reach nearly 80% by 2029. With virtual twins situation is different. Only 10% of providers use them today, but 51% plan to adopt them within the next four years. This work is backed by major EU research projects like the European Virtual Human Twin initiative and several Horizon Europe programmes. Novel biological sensors are progressing at different speeds, with wearable devices further along than ingestible ones. Both face challenges around safety, ease of use, and getting regulatory approval. Genomics technologies are still in early days, with only 4 to 16% adoption, but investment interest is strong, with 48 to 54% of providers planning to invest. This is driven by EU efforts like the one million genomes initiative and the Genomic Data Infrastructure project.

Our Venture Builder is looking for projects in the digital health market and is ready to help founders develop them. If you have such a project, please send your investment deck to us [email protected]

News from the innovative   for healthtech and life science startups in the Baltic region.Finnish Audicin (mental health)...
14/04/2026

News from the innovative for healthtech and life science startups in the Baltic region.

Finnish Audicin (mental health) secures $1.9 million to scale real-time nervous system tech across apps and wearables

Estonian Validfor raises $1.2 mililion pre-seed to cut pharma validation timelines from months to weeks

Lithuanian WhiteBridge.ai raises €2.6 million seed to expand AI-driven people research platform

We also invite you to participate in our "Map of the Baltic Ecosystem" study and fill out your information (links to the study are in the first comment).

Back for another round of our Friday series!We continue our Friday series where we review and announce studies that we f...
10/04/2026

Back for another round of our Friday series!

We continue our Friday series where we review and announce studies that we find interesting and that we recommend investors and founders pay attention to.

Today, we will be providing an overview of the report “DiGA-Report 2025” published by SVDGV. Digital Health Applications have become a regular part of German healthcare, but their future depends on whether policymakers address the bureaucratic and technical barriers that still make it too difficult for patients to use them.

The numbers show strong growth. Since October 2020, more than 1.7 million patients have been treated with a DiGA. In 2025 alone, approximately 690,000 prescription codes were redeemed, which is a 64 percent increase compared to the previous year. The total number of redemptions reached 1.6 million by December 2025, meaning that the fifth year almost doubled the combined total of the four preceding years. There are now 58 DiGA listed in the BfArM directory, with 48 permanently listed and ten preliminarily listed. The market has stabilized at a high level. Notably, 70 percent of initially preliminarily listed DiGA successfully completed their trial year and achieved permanent listing, which shows that the fast-track procedure reliably identifies effective digital therapies. Most DiGA are for mental health conditions, followed by musculoskeletal issues as well as hormones and metabolism. The largest and fastest-growing user group is patients aged 50 to 64 years, followed by a steadily increasing share of users aged 65 and older.

Germany has also become an international role model. Switzerland will start reimbursing German-style digital health applications for depression under its mandatory health insurance in July 2026. A Franco-German declaration signed in June 2025 aims to harmonize evaluation frameworks for Digital Medical Devices across Europe.

However, the report also identifies serious problems that need to be fixed. A pilot project in Hamburg found that only 12.6 percent of digital prescriptions were fully redeemed digitally, compared to 50 to 70 percent with the traditional paper-based process. Patients need up to nine steps to redeem a digital DiGA prescription, whereas redeeming a drug prescription takes just two steps. Additional hurdles include installing multiple apps, requesting a PIN for the electronic health card, and setting up a GesundheitsID, which only 6 percent of insured people have done. The SVDGV therefore wants a redesigned process that would allow patients to start their therapy within minutes instead of waiting weeks.

The newly introduced accompanying outcome measurement, known as AbEM, came into force in February 2026. It is meant to link 20 percent of DiGA reimbursement to real-world outcomes. The SVDGV supports the goal of value-based healthcare, but the current implementation creates a lot of administrative work without providing useful insights. The required surveys may even disrupt therapy, especially for vulnerable patients. The association therefore calls for a simpler approach that works with existing data collection, such as the new Research Data Center for Health launching in 2026.

Data security requirements have also created new challenges. Since January 2025, DiGA must be certified according to the BSI Technical Guideline TR-03161. Regarding evidence standards, all permanently listed DiGA have submitted at least one prospective randomized controlled trial, and many manufacturers now submit multiple RCTs. However, traditional bias assessment tools such as RoB-2 often rate DiGA studies as having a high risk of bias because patients cannot be blinded to their treatment. The same issue applies to psychotherapy research, where blinding is also impossible.

Our Venture Builder is looking for projects in the digital health market and is ready to help founders develop them. If you have such a project, please send your investment deck to us [email protected]

Address

Gustava Zemgala Gatve 78/1
Riga
LV-1039

Telephone

+37125707030

Website

https://lab.4pmventures.com/

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