Starting point

The care gaps are well documented – but only visible in aggregate

Population studies with measured blood pressure and international reports compare actual with documented care. They establish the gaps – as averages. For targeted interventions that is not enough.

Identification
around 36 %

of adults aged 30 to 79 in Germany have high blood pressure – roughly 20 million people.2

Early diagnosis
1 in 5

is unaware of their condition – hypertension is asymptomatic.2

Guideline adherence
1 in 10

of those diagnosed receives no treatment.2

Pathway & adherence
about half

of people with hypertension in Germany are adequately controlled.12 Globally, fewer than one in five of the 1.4 billion people affected in 2024 were adequately controlled.34

Why this matters: elevated blood pressure is held responsible for around 54 % of all strokes and 47 % of all cases of ischaemic heart disease.1 Behind the percentage points are avoidable strokes and heart attacks – and people who go without the right therapy longer than necessary.

For context: in the international comparison, Germany ranks among the countries with the highest treatment and control rates.4 So even well-performing systems reach only about half of those affected – the gap is not a German peculiarity but a structural one.

What the average hides. An average says a gap exists. Linked treatment, laboratory and mortality data say where it arises, whom it affects and what it costs: real treatment trajectories, therapy switches, time to blood pressure control, and the link to events and mortality – longitudinal and by cohort instead of a national mean. Only then can an intervention be sized: how large is the addressable group, at which stage of the pathway does care break down, and what effect is realistic?

How wide that variation is shows in an analysis of routine data from 89 English general practices: between the lowest and the highest performing practice there was a more than tenfold difference in the likelihood of achieving the hypertension quality indicator – and most of that variation could not be explained by routinely recorded patient or practice characteristics.6 A German routine-data analysis points the same way: up to 80 % of the variation in quality indicators was attributable to the individual practice – though based on only eight practices.5 Exactly this variation disappears in any average – and with it the entry point for any targeted intervention.

Three options

Three use cases, three entry points in the treatment pathway

The three use cases improve care at different points of the treatment pathway. Because they act precisely where care actually breaks down, they do not work by watering can: system resources – practice time, diagnostics, avoidable hospitalizations – go where they have the greatest effect and are saved elsewhere. What separates them is how quickly, and with how much effort, they can be delivered.

01 · Identification

Care gap map

Linked real-world data – treatment, laboratory and mortality data in one common data model – show, anonymized and close to the process, where, for whom and when care breaks down. Output: a heat map and cohort dashboard instead of an average.

Effect in the pathway: prioritizes and sizes every further measure – and is therefore the precondition for targeting interventions at all.

Risks: data quality and representativeness (panel bias)14, limited data availability in Germany, GDPR requirements, correlation is not causation.

02 · Decision

Clinical decision support (CDSS)

Guideline-aligned recommendations and risk-stratified signatures in the practice system – at the point of the therapy decision.8 In a cluster-randomised trial in Chinese primary care (n = 12,137), a guideline-based CDSS raised guideline-concordant treatment by 15.2 percentage points.7

Effect in the pathway: the strongest substantive lever on quality of care – right where therapy is determined.

Risks: MDR and high-risk AI under the EU AI Act15, liability and reimbursement questions, fragmented system landscape, automation bias. The evidence comes from a different health system and does not transfer unexamined.

03 · Adherence

Telemonitoring & coaching

Blood pressure self-measurement with escalation logic and patient-facing support close the gap between practice visits – where adherence is actually decided.

Effect in the pathway: keeps patients in the target range and prevents silent drop-off – the stage at which most people are lost.

Risks: MDR, escalation logic as high-risk AI, personal data, selection bias, staffing effort, open reimbursement question.

Assessment

Seven implementation criteria for assessing use cases and setting a priority

Each use case is scored from 1 to 5 and weighted. Effect and feasibility carry the most weight; regulatory requirements enter as their own criterion so that they stay visible instead of dominating the discussion.

Financial impact 20 % Feasibility 20 % Qualitative impact 15 % Time-to-value 15 % Regulatory requirements 15 % Strategic fit 10 % Ethics & acceptance 5 %
High-quality data comes first It starts with mapping the reality of care using real-world data – for example in a care gap map. In this assessment it reaches the highest weighted overall score, with top marks for feasibility, time-to-value and regulatory requirements.
  • It is the enabler: only a solid data foundation makes the other two assessable and the business case viable – you have to see and quantify the gap before you can close it deliberately.
  • Data quality decides everything that follows: completeness, representativeness and coding quality determine whether an analysis becomes a basis for decisions or an artefact.14
  • Decision support has the largest single effect on quality of care – but regulation shifts the when, not the strategic fit.
  • Early, presentable results build trust before investing in the regulatory-heavy building blocks.
The concrete start

What happens in the first months

An initiative of this kind does not begin with a platform, but with a precise data request and a clarified compliance route. Three steps are enough to arrive at a robust basis for decisions.

Month 1

Scoping & access

Define objectives and assessment criteria, agree the clinical questions, formulate the data request and work through the compliance and data protection process.

From month 2

Build

Build care gap dashboards by region, segment and comorbidity – and check data quality, completeness and representativeness before any interpretation.14

After three months

Assessment & decision

A quantified care gap map, tested success criteria and a decision paper: strengthen the data basis, set up an intervention – or decide against it with reasons.

The success criterion is not the dashboard but a decision: where is an intervention worthwhile, how large is the group affected – and is the data basis good enough to build on?

Data protection and governance belong in the first step, not the last

A care gap map works with anonymized care data without individual-level reference and without a medical purpose: no diagnosis, no monitoring, no therapy recommendation. Processing and storage take place in a European data space, and interpretation of the results stays under human oversight. The legal basis for secondary use is set by the European Health Data Space and Germany’s Health Data Use Act.16

The flip side belongs with it: anonymization limits granularity and rules out any individual outreach. Anyone who wants to address individual patients needs a different route – and a different legal basis. It is precisely this boundary that decides whether an initiative stays quick to deliver or turns into a major regulatory project.

Digital roadmap

See → Treat → Decide

The three use cases are not competing project ideas; they trace a digital roadmap for hypertension care: with each stage, data maturity and clinical effect grow, and each stage creates the data foundation for the next.

01 · See

Create visibility

Care gap map: quantify the gaps with RWD by region, segment and comorbidity and make the business case robust – fast, and without medical device certification.

02 · Treat

Improve care operationally

Telemonitoring and coaching: use patient-generated data to improve control between practice visits – care steering close to real time.

03 · Decide

Regulated decision support

CDSS and locally trained risk signatures: explainable and source-based, with final sign-off by a human – only meaningful on a solid data foundation.

Closing the loop: measured outcomes feed back into prioritization. The roadmap becomes a closed care data chain – the foundation of outcome-oriented care.

A larger movement sits behind this: the digital mapping of the care pathway with RWD is becoming increasingly important, and with it evidence generation along the entire pathway – no longer only at the point of approval, but continuously in the reality of care. Care organized this way can improve quality substantially, because it makes effects measurable and directs resources to where they actually change outcomes.

The wider context

Lines of development in data-driven care

In the large consultancies’ analyses, real-world evidence is moving from a data source to a strategic asset – from downstream evidence to a standing basis for care and portfolio decisions.910 Four forces drive this development; they explain why a care gap map is more than a dashboard project.

Regulation

Real-world evidence increasingly enters regulatory submissions – for label extensions and safety evidence.10

Payers

Payers ask for real-world benefit, not just trial efficacy – under considerable cost pressure.9

Personalization

Understanding patient groups beyond controlled trials: subpopulations, non-responders, treatment discontinuation.13

AI & GenAI

Large data volumes become faster and cheaper to analyse – evidence generation becomes scalable.12

How seriously the market takes this shift is visible in the large consultancies' surveys. These figures come from industry surveys and estimation models, not from peer-reviewed research – they describe a direction, not a proven effect:

96 % of surveyed biopharma companies consider real-world data and evidence very important or business-critical; the same share expects rising investment.12
> USD 300m per year could be unlocked by an average top-20 pharma company across its value chain by adopting advanced RWE analytics (estimate, 3–5 years).9
80 % of surveyed executives expect generative AI to significantly change the generation of real-world evidence within a year.12
56 % / 44 % expect GenAI in evidence generation to reduce costs and timelines (56 %) and to increase efficiency and productivity (44 %).12

The step from product logic to patient logic does not happen in one department

The right treatment at the right time for the right patient – that is the step from a product-centric to a patient-centric logic.9 Inside a company it does not happen in a single department: the consultancy analyses attribute the success of such efforts explicitly to interdisciplinary teams – clinical medicine, epidemiology, analytics and the business function working together instead of separate analytical cultures.13 The transparency this creates works in both directions: it makes the benefit visible for every function involved – and at the same time shortens the patient’s path to the best possible individual therapy.

Business

  • Prioritization of care gaps and measures
  • A shared data basis with providers and payers
  • Early robust results, scalable without MDR effort
  • Quantifying the size and structure of the group affected

Medical

  • Making the reality of care and unmet need demonstrable
  • Comorbidities and safety signals in everyday care
  • Guideline-aligned, publishable care evidence58
  • Basis for study designs

Digital

  • Scalable data and analytics platform
  • Training own models, basis for further use cases
  • Sovereign EU stack, common data model (FHIR)
  • Governance and human oversight from the start

The real lever lies in collaboration: when business functions, providers and payers look at the same data basis, tomorrow’s care can be shaped together. Real-world data and continuous data chains are the precondition for that.

The legal framework for this is taking shape: the European Health Data Space and Germany's Health Data Use Act govern the secondary use of health data and will make analyses of exactly this kind more reliably plannable in the coming years.16

Transferability

What transfers is the method, not the indication

Hypertension serves as the example here because the evidence base is solid and the care gap is large. The logic works for any indication and any context in which several AI and digital ideas compete for the same resources: bring clinical benefit, feasibility and regulatory requirements together in one decision paper – and derive a sequence from it instead of a wish list.

That is where my work sits: orchestrating interdisciplinary teams and departments – bringing the business function, medical, data and regulatory affairs to one table, identifying the right use case first, testing it against regulatory reality, and supporting delivery until it is anchored in everyday work.

What is established – and what is not. It is established that real-world data makes care gaps visible, and that a guideline-based CDSS raised guideline adherence in a randomised trial – in a different health system. That data-driven care improves quality overall is plausible and supported by industry analyses, but not established in this form. That distinction belongs in every decision paper – it determines whether an initiative is later measured against its own promises or against what it can actually deliver.

Context This is an illustrative case study with no client reference. No implementation, no case-by-case regulatory assessment, no recommendation for any specific product or vendor, and no substitute for legal, professional or medical advice. All figures cited come from the sources listed below; consultancy market figures are survey or estimated values.
References

Sources

Accessed: August 2026. Sources 1–8 are peer-reviewed or institutional, 9–14 are industry analyses, 15–16 are legal sources.

  1. Neuhauser H, Thamm M, Ellert U. Blutdruck in Deutschland 2008–2011. Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1). Bundesgesundheitsblatt. 2013;56:795–801. doi:10.1007/s00103-013-1669-6.
  2. Deutsche Hochdruckliga e.V. DHL. Bluthochdruck in Zahlen – background information. Available from: hochdruckliga.de.
  3. World Health Organization. Global report on hypertension 2025: high stakes – turning evidence into action. Geneva: WHO; 2025. Available from: who.int.
  4. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398:957–980. doi:10.1016/S0140-6736(21)01330-1.
  5. Strumann C, Engler NJ, von Meissner WCG, Blickle PG, Steinhäuser J. Quality of care in patients with hypertension: a retrospective cohort study of primary care routine data in Germany. BMC Prim Care. 2024;25:54. doi:10.1186/s12875-024-02285-9.
  6. Willis TA, West R, Rushforth B, Stokes T, Glidewell L, Carder P, Faulkner S, Foy R. Variations in achievement of evidence-based, high-impact quality indicators in general practice: an observational study. PLoS One. 2017;12(7):e0177949. doi:10.1371/journal.pone.0177949.
  7. Song J, et al. Guideline based decision support system to improve hypertension treatment in primary care in China: cluster randomised controlled trial. BMJ. 2024;386:e079143. doi:10.1136/bmj-2023-079143.
  8. McEvoy JW, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024;45:3912–4018. doi:10.1093/eurheartj/ehae178.
  9. Champagne D, Devereson A, Pérez L, Saunders D. Creating value from next-generation real-world evidence. McKinsey & Company, Life Sciences Practice; 23 July 2020. Available from: mckinsey.com.
  10. Deloitte Insights. Real-world evidence’s evolution into a true end-to-end capability. Deloitte Center for Health Solutions; 21 September 2022. Available from: deloitte.com.
  11. Deloitte Insights. 2025 life sciences outlook. Deloitte Center for Health Solutions; 10 December 2024. Available from: deloitte.com.
  12. Converge™ by Deloitte. Real-world evidence and Generative AI: a powerful platform for innovation. 2025 RWE Benchmark Survey. 2025. Available from: deloitte.com.
  13. Anagnostopoulos C, Champagne D, Devereson A, Huijskens T, Macak M. Generating real-world evidence at scale using advanced analytics. McKinsey & Company, Life Sciences Practice; 15 March 2022. Available from: mckinsey.com.
  14. Anagnostopoulos C, Devereson A, El Turabi A, Pereira Arias E, Westra A. Real-world data quality: what are the opportunities and challenges? McKinsey & Company, Life Sciences Practice; 5 January 2023. Available from: mckinsey.com.
  15. European Parliament, Council of the European Union. Regulation (EU) 2024/1689 (AI Act) and Regulation (EU) 2017/745 (MDR). Official Journal of the European Union. Available from: digital-strategy.ec.europa.eu.
  16. European Parliament, Council of the European Union. Regulation (EU) 2025/327 on the European Health Data Space (EHDS); German Health Data Use Act (GDNG), BGBl. 2024 I No. 102. Available from: eur-lex.europa.eu.
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