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100%
EU market readiness.
From the first compliance gap analysis to a fully documented health data framework — Seer Medical entered the European market without a single outstanding regulatory issue.
0
compliance gaps.
The GDPR and MDR compliance framework was delivered without a single open issue. A result that reflects Chino.io's depth of legal and technical implementation in digital health.
3
frameworks covered.
GDPR Article 9, EU MDR, and HIPAA requirements were addressed in one unified architecture — giving Seer Medical a compliance foundation that scales with their global expansion.
100%
EU market readiness.
From the first compliance gap analysis to a fully documented health data framework — Seer Medical entered the European market without a single outstanding regulatory issue.
0
compliance gaps.
The GDPR and MDR compliance framework was delivered without a single open issue. A result that reflects Chino.io's depth of legal and technical implementation in digital health.
3
frameworks covered.
GDPR Article 9, EU MDR, and HIPAA requirements were addressed in one unified architecture — giving Seer Medical a compliance foundation that scales with their global expansion.

About the Company

Seer Medical is a digital health company making epilepsy diagnostics more accessible by combining medical expertise with technology. Their platform enables patients to undergo EEG and ECG monitoring at home — removing the need for costly hospital stays and bringing clinical-grade neurological assessments to everyday life.

The Challenge

Neurological data sits at the most protected tier of personal data under European law. As Seer Medical expanded into the EU, every patient record — every EEG trace, every seizure log — fell under the strict special category provisions of GDPR Article 9, requiring a level of legal and technical diligence far beyond standard data protection.

The Solution

Seer Medical chose Chino.io for their combination of legal expertise and technical implementation capability — a rare pairing in the compliance space. Unlike platforms that treat compliance as a checklist, Chino.io embedded directly into Seer Medical's product and infrastructure workflows.

Key components of the solution

  • GDPR Article 9 compliance framework
  • Consent infrastructure for clinical data
  • Data Processing Agreements (DPAs)
  • MDR-aligned technical safeguards
  • Expert guidance throughout

The Result

With Chino.io's framework in place, Seer Medical entered the European market with a defensible, documented compliance posture — giving clinical partners, hospital systems, and enterprise customers the confidence to work with the platform. Beyond enabling market expansion, the process matured Seer Medical's internal data governance significantly. Patient data is now handled with a level of rigour that strengthens trust not just with regulators, but with the patients whose most sensitive health data flows through the platform every day.

About the Company

Seer Medical is a digital health company making epilepsy diagnostics more accessible by combining medical expertise with technology. Their platform enables patients to undergo EEG and ECG monitoring at home — removing the need for costly hospital stays and bringing clinical-grade neurological assessments to everyday life.

The Challenge

Neurological data sits at the most protected tier of personal data under European law. As Seer Medical expanded into the EU, every patient record — every EEG trace, every seizure log — fell under the strict special category provisions of GDPR Article 9, requiring a level of legal and technical diligence far beyond standard data protection.

The Solution

Seer Medical chose Chino.io for their combination of legal expertise and technical implementation capability — a rare pairing in the compliance space. Unlike platforms that treat compliance as a checklist, Chino.io embedded directly into Seer Medical's product and infrastructure workflows.

Key components of the solution

  • GDPR Article 9 compliance framework
  • Consent infrastructure for clinical data
  • Data Processing Agreements (DPAs)
  • MDR-aligned technical safeguards
  • Expert guidance throughout

The Result

With Chino.io's framework in place, Seer Medical entered the European market with a defensible, documented compliance posture — giving clinical partners, hospital systems, and enterprise customers the confidence to work with the platform. Beyond enabling market expansion, the process matured Seer Medical's internal data governance significantly. Patient data is now handled with a level of rigour that strengthens trust not just with regulators, but with the patients whose most sensitive health data flows through the platform every day.

Frequently Asked Questions

How does ChecksME help with RoPA?

ChecksME provides easy-to-use templates to help you create and manage your Records of Processing Activities (RoPA), ensuring you stay compliant with GDPR.

What is an AI system?

The legal framework's definition of an AI system aims to be as technology-neutral and future-proof as possible, considering the fast technological and market developments related to AI. A machine-based system designed to operate with varying levels of autonomy that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments. So, an AI system is basically any machine-based setup that can work on its own to some degree. It can adapt after it’s been launched, and it figures out how to produce outputs like predictions, content, recommendations, or decisions based on the data it gets. These outputs can then impact both the digital and physical world.

How much does it cost?

The tool is free to use up to 50 questions per months, if you need more you can subscribe to the paid version.

What regulations does it cover?

At the moment we cover GDPR and HIPAA, since ChecksMATE was born to solve the nightmare of data protection regulations in the healthcare space. We are working on adding more standards to the platform natively, but with these basis and our expert team, we help companies comply with several other standards, such as ISO27001, NHS DTAC, DiGA requirements (including BSI200), PECAN requirements and much more!

How accurate is the tool?

Like any AI, the tool may make mistakes. However, you can consult the source of the answer for a better understanding of the AI's response. When necessary, you can ask one of our consultants to review the answer and provide a report to you.

What is a DPO?

Under GDPR, the data protection officer (DPO) can be thought of as the champion of data subject rights. That is, she is the person upholding the privacy rights of the end users of your application. The GDPR makes it very clear what a DPO must do: (1) Inform the company and their staff what their duties are under GDPR and related regulations. (2) Monitor their compliance with GDPR, including assigning responsibilities and ensuring staff are appropriately trained (3) Providing advice relating to the data protection impact assessment (DPIA) and ensuring the company complies with it. (4) Cooperate with the supervising data protection authority.

What are SARs and DSRs?

SARs (Subject Access Requests) allow individuals to access personal data an organization holds about them. DSRs (Data Subject Requests) cover broader rights, like data rectification or deletion.

Is it suitable for startups?

ChecksMATE was the tool we developed internally to help companies manage compliance such as startups, SMEs and corporates. ChecksMATE was created by a startup by working with startups, and startups are most of our customers. Along the way we figured out that enterprises ended up needing pretty much the same tools, since product departments try to work as startups too, so everyone is welcome to use ChecksMATE to comply with data protection laws easier and faster.

Who is a Provider?

Provider: who develops any AI system and sells it or makes it available under their name or brand, whether for money or for free.

Who is a Deployer?

Deployer: who uses an AI system within their organisation, except when the AI system is used for personal, non-professional activities.

What regulations do you cover?

The AI is trained on GDRP, HIPAA, DVG-BSI, and AI-ACT. We are updating the knowledgebase daily to improve the assistant daily.

Can I handle data breaches and SARs with ChecksME?

Yes, ChecksME offers tools to manage data breaches, SARs, DSRs, and other compliance tasks, making day-to-day GDPR management simple. ChecksME can streamline compliance with SARs, DSRs, and data breaches, ensuring quick, accurate responses while reducing legal risks for your organisation.

When do you need a DPO?

There are various reasons why you may need a DPO. The GDPR sets out three main ones: (1) If you are a public authority (or by implication, if you are acting on their behalf). (2) If you are conducting systematic monitoring on a large scale. This usually means CCTV surveillance, but also covers other cases. (3) If you are processing a lot of sensitive data.

How much does ChecksMATE cost?

ChecksMATE is included in the price of our Compliance Partner & DPO services.

Will medical devices be labelled as High Risk?

Many existing AI solutions used in healthcare are integrated into medical devices regulated under the MDR. Most of them will qualify as high-risk AI systems under the AI Act. 👉​ What does this mean? Digital Health companies must ensure compliance with both MDR and the corresponding requirements of the AI Act. It will apply to any DTx, Decision Support Systems, and any other software as a Medical Device that uses AI.

Do I need previous experience to use ChecksMATE?

Certainly not! We aimed to make the platform as self-explanatory as possible. We know though that data protection is complex, and it’s pretty much impossible to keep all the legalese away. In particular when making tough decisions (data controller or data processor? How to describe the purpose of my data processing activities?) So when you feel lost or you’re uncertain about what is the right answer to these questions, you can just reach out to your team and get them all sorted out by an expert!

What is GDPR and why is it important for my company?

GDPR is a European regulation designed to protect personal data. For startups in digital health dealing with sensitive information, compliance is crucial to avoid fines and protect user trust.

How can a DPO help?

A DPO can help identifying and solving a wide range of topics, such as: (1) Assessing whether your providers are compliant. Under GDPR, you need to make sure all your providers and contractors are themselves compliant with GDPR. (2) Responding to data subject rights requests. One of the most important things a DPO can do is help you respond to requests regarding the rights of data subjects. (3) Maintaining your GDPR documentation. There are a number of key documents relating to GDPR and some of these are mandatory (e.g. privacy policy or records of processing activities) and some are only needed in some cases (e.g. DPIA).

Can I use the service if I already have a DPO?

Of course, while we offer the option of becoming your DPO ourselves, you can also use the platform as a DPO yourself, and even get the support of our team when getting tough questions.

What should I do if my AI is considered "High-Risk"?

Being “labelled” as a High-Risk AI System means that you have requirements to fulfil to be able to sell your AI. Such as: Risk Management System, Data Governance, Technical Documentation, Record-Keeping, Transparency and Information for Deployers, Human Oversight, Accuracy, Robustness, and Cybersecurity.

What other reasons are there to have a DPO?

There are also a couple of other reasons for appointing a DPO. For instance: (1) Because you are working with an organisation that asks you to appoint one. Typical examples are digital health startup conducting clinical trials with a hospital or Clinical Research Organisation. (2) If you are a B2B company processing a lot of data on behalf of large companies. Then they may ask you to have a DPO to help protect them and their reputation.

Can I use it without getting consulting support?

Indeed!

Who can be a DPO?

There are various strict requirements about who can act as your DPO. For a start, they must be an expert in data privacy law. That means knowing GDPR inside-out. Then there’s the requirement to be independent. That means they can’t have an executive role in the company. Otherwise, they wouldn’t be acting on behalf of the data subjects. Thirdly, the DPO must be in a position to provide advice whenever needed. Importantly, the GDPR does allow you to outsource your DPO role. That’s particularly helpful for startups who typically struggle to find someone internally that matches the requirements above.

Will you write the documentation for me?

Yes, the team is available to write the documentation for you whenever required. The more you progress providing input in the platform, the more cost effective these services will be!

What languages do you support?

Currently the platform is in English, and we are working on our German and Italian versions - our experts speak multiple languages, if you are in need of any in particular feel free to ask!

What our customers say

From GDPR to HIPAA and beyond, Chino.io helps health-tech teams hit every regulatory milestone without losing momentum.
Henesis
CTO Seer Medical
"The right partner should have technical experience. In this case, specifically, you were a good partner because we also had real experience in the legal part, so we could cover it from the technical and legal points of view."
Seer Medical
CTO Seer Medical
“The beauty of working with Chino.io is their problem-solving approach. They are always available when we need.”
Nuralogix
CTO Seer Medical
“Chino.io made GDPR compliance easy. Without them, we would never have been able to ‘go-to-market’ so quickly and confidently in the EU.”
Eumaco
CTO Seer Medical
“Using Chino.io we completely eliminated the risks related to GDPR non-compliance, allowing us to easily upgrade our existing platform.”