Risk Intelligence Infrastructure for European Health Systems

Built for GDNG compliance. Designed for clinical trust.

Federated Learning

Our Federated Architecture keeps you up to date while keeping your data in your control.

Sovereign Architecture

Created from the ground up for compliance.
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Clinically Validated

A randomized controlled trial is underway with Charité Berlin to measure health outcomes.

For Health Insurers

Loretta is a federated risk intelligence platform that helps payers and providers stratify chronic disease populations and target preventive interventions.

About Loretta

For Health Systems

Loretta is able to integrate in existing workflows to support clinical decisions. We have evidence-based intervention recommendations grounded in causal analysis. With our support we can help you reduce avoidable hospitalizations through early intervention.

About Loretta

For Patients

Loretta is a federated risk intelligence platform that helps payers and providers stratify chronic disease populations and target preventive interventions.

About Loretta

FAQs

In this section, you'll find answers to common questions about our AI-driven platform and how it empowers personalized health care.

General questions

What is Loretta?

Loretta is a B2B health AI infrastructure platform that helps insurers and health systems predict chronic disease risk and target preventive interventions, without centralizing patient data.

Is Loretta an app?

No. Loretta is infrastructure that runs inside institutional environments (trust centres, hospital IT, insurer data centres); an optional patient-facing interaction layer can be enabled, but always under the institution's control.

Which problems does Loretta solve for health systems and insurers?

Loretta helps reduce avoidable hospitalizations and long-term chronic care costs by identifying who is at risk, which interventions are likely to work, and how to allocate resources fairly across populations.

Data, Privacy & Sovereignty

Where is patient data stored and processed?

Patient data remains inside the responsible institution's secure processing environment (Trust‑Centre or equivalent); Loretta's components are deployed locally and central systems only receive aggregated, non‑identifiable parameters.

Is Loretta compliant with GDPR and the German Health Data Use Act (GDNG)?

Yes. Loretta's architecture is designed around GDPR principles and GDNG requirements for secondary use of health data, including use of secure processing environments and prohibition of cross‑border raw data transfers.

Does Loretta export any personal health data to US cloud providers?

No. Loretta does not move personal health data outside the responsible institution or into non‑sovereign cloud environments; this is a core design choice to meet GDNG and EHDS sovereignty requirements.

What is "secondary use" of health data and how does Loretta fit?

Secondary use means using health data for research, planning, and prevention rather than direct clinical care; GDNG and EHDS explicitly legalise such use under strict safeguards, and Loretta provides the technical implementation to do this safely.

Technology

How does Loretta address health disparities?

We combine AI-driven solutions with a deep understanding of social and environmental factors to create tailored healthcare experiences. Our evidence-based platform is designed to eliminate stigma and provide continuous support for chronic disease management, mental health, and wellness.

How does Loretta use federated learning?

Models are trained across decentralized nodes inside "Trust‑Centres" (Sichere Verarbeitungsumgebungen, SPE), so raw patient data never leaves institutional custody; only encrypted model updates are aggregated centrally.

What is "causal inference" and why does it matter?

Causal inference methods estimate the effect of an intervention (for example a diabetes management programme) rather than just correlation, allowing Loretta to model "uplift" and benchmark estimates against randomised controlled trials within about a 20% margin.

How does Loretta address bias and fairness?

Loretta infers socioeconomic status (SES) from privacy‑preserving proxies and constrains models so that performance disparities (for example false negatives) between SES groups stay below about 5%, in line with emerging fairness research and regulatory expectations.

Does Loretta replace clinicians or case managers?

No. Loretta augments existing workflows with risk scores and intervention suggestions; all decisions remain under human oversight and institutional clinical governance.

Regulation & Evidence

How does Loretta align with the European Health Data Space (EHDS)?

EHDS requires each member state to build interoperable health data spaces and designate data access bodies; Loretta is built to run within these national infrastructures, making it easier to extend from Germany to other EU markets.

Is Loretta considered a "High‑Risk AI system" under the EU AI Act?

Yes. Health prediction and intervention support systems fall under the High‑Risk category, so Loretta implements required controls such as risk management, data governance, transparency, human oversight, and bias and fairness testing.

What regulatory pathways is Loretta pursuing?

Loretta is working toward TÜV certification as a Class IIa medical device, preparing AI Act documentation, and building the evidence required for DiGA reimbursement where a patient‑facing component is involved.

What clinical evidence will support Loretta?

A clinical randomized controlled trial is planned to demonstrate improvements in outcomes such as HbA1c and blood pressure, with all results stratified by SES to test equity.

Use Cases & Integration

Who are Loretta's primary customers?

German statutory health insurers (GKV) and large health systems are the initial focus, with expansion to other EU payers and providers as EHDS infrastructures come online.

Which diseases does Loretta focus on first?

Initial deployments target high‑burden chronic conditions such as type 2 diabetes and hypertension, with a roadmap to extend to other cardiometabolic and respiratory diseases.

How does Loretta integrate with existing systems?

Loretta connects to claims and EHR systems via standard interfaces such as HL7/FHIR and operates within existing secure processing environments, reducing the need to change institutional IT.

Can Loretta support workplace or employer programmes?

Yes. Through insurer or provider partnerships, Loretta can power employer health programmes using the same risk and intervention engine, with pricing aligned to per‑member‑per‑month models.

Patient Interaction Module

Does Loretta provide a patient app?

Loretta offers an optional interaction module that institutions can white‑label to deliver reminders, education, and monitoring; it is not a standalone direct‑to‑consumer app and operates entirely under institutional governance.

Who controls patient communications and recommendations?

All messages, prompts, and recommendations delivered through the patient layer are triggered and approved under institutional clinical rules and oversight; Loretta provides the tooling, not autonomous decision‑making.

Does the patient module change Loretta's regulatory status?

A governed patient interface can be included within a DiGA‑style pathway where appropriate; regulatory classification depends on the specific configuration and intended use agreed with the institution.

Economics & Value

How does Loretta create financial value for insurers and health systems?

By preventing avoidable hospitalizations and complications in high‑risk chronic patients, Loretta aims to reduce per‑patient costs and address structural deficits in systems like GKV, where chronic disease accounts for most spending.

How is Loretta priced?

Loretta is priced as an enterprise licence per insurer or health system (annual contract value) with optional per‑member fees when a patient interaction module is deployed at scale.

What return on investment can institutions expect?

Existing prevention programs in Germany show 3–5× ROI over three years; Loretta's goal is to enable similar or better returns by making prevention more targeted, timely, and equitable.

For Patients

Will Loretta have access to my medical records?

Only if your doctor, hospital, or health insurance decides to use Loretta's tools to help manage your care. Even then, your data stays with your healthcare provider and is never shared outside their secure systems. Loretta is a tool they use like a calculator not a separate company collecting your information.

How will I know if Loretta is being used in my care?

Your healthcare provider or insurer will inform you if they are using Loretta to support your treatment plan. In some cases, you may receive helpful reminders or personalised health tips through an app or messages but only if your provider has set this up for you. You can always ask your care team if and how Loretta is being used.

Do I need to give permission for Loretta to be used?

Your healthcare provider or insurer will follow all legal requirements for consent and data protection under German and EU law (GDPR and GDNG). If you have questions about how your data is used, speak to your doctor's office or insurance representative they control all decisions about your information.