Postgraduate Diploma in Digital Services Regulation and Reimbursement
The Postgraduate Diploma in Digital Services Regulation and Reimbursement explores the legal framework and reimbursement practices applied to digital services, covering current legislation, consumer protection policies, and industry standards. It focuses on understanding reimbursement processes, managing disputes, and complying with regulations such as GDPR/CCPA, which are essential for the operation of digital platforms. It analyses electronic transactions, privacy policies and conflict resolution methods to ensure compliance and transparency in the digital sector.
The programme provides skills for implementing efficient reimbursement systems, mitigating legal risks, and managing the user experience in a regulated environment. It prepares students for roles such as regulatory compliance specialists, reimbursement managers, digital policy analysts and legal advisers, fostering adaptability and success in the digital economy.
Postgraduate Diploma in Digital Services Regulation and Reimbursement — studying from India
India's medical device and healthcare technology sector is growing, with manufacturing and design clusters in Hyderabad, Bengaluru, Ahmedabad and the National Capital Region. Regulation of medical devices is handled by the Central Drugs Standard Control Organisation under the Central Drugs Standards Control Organisation framework, and the Bureau of Indian Standards issues relevant norms. Hospitals, device makers and rehabilitation technology firms create demand for biomechanics and wearables expertise. Operational safety and occupational health are overseen through the Directorate General Factory Advice Service and Labour Institutes, making this area relevant to industrial and healthcare engineers alike.
Fees for India: ₹190,000 (Indian Rupee), with instalments and employer sponsorship available.
Relevant bodies in India
Typical roles
Questions from India
Will this programme be recognised by professional bodies in India for health and biomechanics work?
SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body in India. Recognition is decided by employers and by the relevant body in each case. Medical devices fall under CDSCO, and professional engineering recognition in India is handled by bodies such as the Institution of Engineers (India). Please check with them directly before relying on the qualification.
Which employers in India use skills in biomechanics, wearables and operational safety?
Typical employers include medical device companies, hospitals with engineering departments, sports science organisations, and firms making wearable or industrial safety products. Hiring depends on the employer's own criteria and on your existing experience. The qualification may help you show specialist knowledge, but whether a particular employer values it is for that employer to decide.
Can I study this alongside a full-time job in India, and does it need English?
The programme is 100% online and taught in English, so you need a working level of English. Time zone is not a barrier because the course is asynchronous, and you can study from anywhere in India without a student visa. Workload depends on the programme length, and each student is assigned a technical tutor for support. Many people fund it through employer sponsorship or pay in instalments.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Describe the digital health ecosystem and its stakeholders.
Classify healthcare software under the MDR.
Apply health technology assessment to digital services.
Compare reimbursement models in Europe.
Analyse reimbursement pathways in the United States and other markets.
Integrate telemedicine requirements into the service model.
Design a market access strategy.
Who it's for
- Market access specialist who wishes to specialise in Digital Services Regulation and Reimbursement.
- Regulatory affairs consultant who wishes to specialise in Digital Services Regulation and Reimbursement.
- Health economics analyst who wishes to specialise in Digital Services Regulation and Reimbursement.
- Reimbursement manager who wishes to specialise in Digital Services Regulation and Reimbursement.
- Digital health product manager who wishes to specialise in Digital Services Regulation and Reimbursement.
- Health technology assessment officer who wishes to specialise in Digital Services Regulation and Reimbursement.
- Graduates in engineering or sciences seeking to enter digital health.
What you'll work with
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2021/2282 (health technology assessment)
- DiGAV (German regulation on digital health applications)
- NICE Evidence Standards Framework for digital technologies
- IMDRF SaMD N12 (classification of software as a medical device)
- Royal Decree 192/2023 (medical devices)
8 modules · 800 h
1.1Apps, telemedicine, digital therapeutics and device software1.2Payers, regulators, providers and patients1.3Public and private delivery of digital services1.4Service portfolio of the National Health System1.5B2C, B2B and B2G business models1.6The boundary between wellness and medical purpose1.7Routes to market access1.8Evidence required at each stage1.9Digital strategies of the EU and the SNS1.10Case study: market access routes for a therapeutic app
2.1MDR 2017/745 and intended purpose2.2Rule 11 for software classification2.3MDCG 2019-11 qualification guidance2.4Notified bodies and CE marking2.5Software lifecycle under IEC 623042.6AI Regulation applied to medical software2.7In vitro diagnostic software (IVDR)2.8FDA: SaMD, 510(k) and De Novo2.9United Kingdom: MHRA and UKCA marking2.10Workshop: classification of five software products
3.1Principles of health technology assessment (HTA)3.2Regulation (EU) 2021/2282 on HTA3.3NICE Evidence Standards Framework3.4MAST model for telemedicine3.5RedETS and regional agencies3.6Cost-effectiveness and quality-adjusted life years3.7Budget impact analysis3.8Real-world evidence and pragmatic studies3.9Value dossier for payers3.10Practice: budget impact model
4.1German DiGA and the BfArM Fast-Track procedure4.2Pricing and negotiation in the DiGA directory4.3PECAN and remote monitoring in France4.4mHealthBE pyramid in Belgium4.5NHS Digital Technology Assessment Criteria4.6Models in Italy and the Nordic countries4.7Situation in Spain and the autonomous communities4.8Comparison of evidence requirements4.9Lessons from DiGAs removed from the directory4.10Case study: reimbursement strategy in Germany and France
5.1CPT codes for remote patient monitoring (RPM)5.2Remote therapeutic monitoring (RTM)5.3Medicare telehealth coverage5.4Breakthrough Devices Programme and coverage5.5Private insurers and pharmacy benefit managers5.6Outcomes-based payment agreements5.7Japan and the approval of digital therapeutics5.8Latin American markets5.9Billing and anti-fraud compliance5.10Case study: coding a remote monitoring service
6.1Legal framework for telemedicine in Spain6.2Professional liability in teleconsultation6.3Electronic prescribing and interoperability6.4Data protection in digital services6.5Innovation procurement6.6Teleconsultation fees and billing6.7Authorisation of healthcare centres and services6.8Cybersecurity requirements for providers6.9Cross-border services in the EU6.10Workshop: tender specification for a remote monitoring service
7.1Integrated evidence generation plan7.2Value proposition by payer type7.3Value-based pricing7.4Risk-sharing contracts7.5Stakeholder and influence map7.6Negotiation with health services7.7Pilots and scaling within the public system7.8Adoption and usage indicators7.9Regulatory and reimbursement risks7.10Workshop: market access plan for three markets
8.1Description of the digital service8.2Qualification and regulatory classification8.3Clinical and economic evidence plan8.4Economic and budget impact model8.5Reimbursement strategy by country8.6Implementation plan8.7Risk analysis8.8Timeline and budget8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the intake, which makes it possible to combine the programme with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is TreeAge Pro, R (heemod), Advanced Excel, Power BI, in free, academic or evaluation versions. Trials are studied using real procedures of cost-effectiveness models, market access files and comparative analysis of reimbursement routes. Assessment is continuous per module, plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the digital health ecosystem and its stakeholders.
Classify healthcare software under the MDR.
Apply health technology assessment to digital services.
Compare reimbursement models in Europe.
Analyse reimbursement pathways in the United States and other markets.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme software.
- Sufficient Spanish to follow technical regulatory reading.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme comprises 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
The programme works with TreeAge Pro, R (heemod), Advanced Excel and Power BI. Free, academic or evaluation versions are used, and the tutor indicates the open-source alternative where one exists.
An SEIUM own diploma upon passing the continuous assessment and the integrative project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the higher-level programme. Please check the credit transfer policy when you enrol.
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