Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

Duration800 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma

Postgraduate Diploma in Digital Services Regulation and Reimbursement — studying from the United States

Health technology and biomechanics form a significant sector in the United States, anchored by medical device hubs in Minnesota, Massachusetts, California and New Jersey. Companies develop implants, diagnostic equipment, rehabilitation devices and wearable sensors under strict regulatory oversight. Engineers apply biomechanical modeling, human factors and operational safety analysis to improve device performance and worker well-being. Careers often involve close collaboration with clinicians and regulatory affairs teams.

Fees for the United States: US$2,000 (US Dollars), with instalments and employer sponsorship available.

Relevant bodies in the United States

  • U.S. Food and Drug Administration (FDA)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • American Society of Mechanical Engineers (ASME)
  • Occupational Safety and Health Administration (OSHA)

Typical roles

  • Biomedical Engineer
  • Biomechanics Engineer
  • Wearables Development Engineer
  • Operational Safety Engineer

Questions from the United States

Which professional bodies in the United States relate to this area, and does a SEIUM qualification make me a licensed engineer?

In the US, the Professional Engineer (PE) license is issued by state licensing boards and generally requires an ABET-accredited engineering degree, supervised experience, and passing the FE and PE exams. Biomedical and safety work also connects to bodies such as ASME and IEEE EMBS. A SEIUM qualification is a private qualification, not a state degree, and does not itself grant PE licensure. Recognition is decided by employers or the relevant licensing body.

Where do people with this training typically work in the United States?

Careers in this area commonly appear in medical device companies, wearable technology firms, hospitals and research institutions, and occupational safety departments in industrial employers. Hiring decisions depend on each employer's requirements and how they value private, non-accredited training, so you should check specific job postings and speak with target employers before enrolling.

Can I study this programme while working full time in the US?

The programmes are 100% online and taught in English, so you can study from home and no student visa is needed. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours, and specialist courses 300 hours, so you should plan your weekly hours realistically. Fees are payable in instalments, and some employers offer sponsorship, which you can ask your employer about directly.

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Learning outcomes

What you will be able to do

01

Describe the digital health ecosystem and its stakeholders.

02

Classify healthcare software under the MDR.

03

Apply health technology assessment to digital services.

04

Compare reimbursement models in Europe.

05

Analyse reimbursement pathways in the United States and other markets.

06

Integrate telemedicine requirements into the service model.

07

Design a market access strategy.

Profile

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.
Standards & tools

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)
Syllabus

8 modules · 800 h

  1. 1.1Apps, telemedicine, digital therapeutics and device software
  2. 1.2Payers, regulators, providers and patients
  3. 1.3Public and private delivery of digital services
  4. 1.4Service portfolio of the National Health System
  5. 1.5B2C, B2B and B2G business models
  6. 1.6The boundary between wellness and medical purpose
  7. 1.7Routes to market access
  8. 1.8Evidence required at each stage
  9. 1.9Digital strategies of the EU and the SNS
  10. 1.10Case study: market access routes for a therapeutic app
  1. 2.1MDR 2017/745 and intended purpose
  2. 2.2Rule 11 for software classification
  3. 2.3MDCG 2019-11 qualification guidance
  4. 2.4Notified bodies and CE marking
  5. 2.5Software lifecycle under IEC 62304
  6. 2.6AI Regulation applied to medical software
  7. 2.7In vitro diagnostic software (IVDR)
  8. 2.8FDA: SaMD, 510(k) and De Novo
  9. 2.9United Kingdom: MHRA and UKCA marking
  10. 2.10Workshop: classification of five software products
  1. 3.1Principles of health technology assessment (HTA)
  2. 3.2Regulation (EU) 2021/2282 on HTA
  3. 3.3NICE Evidence Standards Framework
  4. 3.4MAST model for telemedicine
  5. 3.5RedETS and regional agencies
  6. 3.6Cost-effectiveness and quality-adjusted life years
  7. 3.7Budget impact analysis
  8. 3.8Real-world evidence and pragmatic studies
  9. 3.9Value dossier for payers
  10. 3.10Practice: budget impact model
  1. 4.1German DiGA and the BfArM Fast-Track procedure
  2. 4.2Pricing and negotiation in the DiGA directory
  3. 4.3PECAN and remote monitoring in France
  4. 4.4mHealthBE pyramid in Belgium
  5. 4.5NHS Digital Technology Assessment Criteria
  6. 4.6Models in Italy and the Nordic countries
  7. 4.7Situation in Spain and the autonomous communities
  8. 4.8Comparison of evidence requirements
  9. 4.9Lessons from DiGAs removed from the directory
  10. 4.10Case study: reimbursement strategy in Germany and France
  1. 5.1CPT codes for remote patient monitoring (RPM)
  2. 5.2Remote therapeutic monitoring (RTM)
  3. 5.3Medicare telehealth coverage
  4. 5.4Breakthrough Devices Programme and coverage
  5. 5.5Private insurers and pharmacy benefit managers
  6. 5.6Outcomes-based payment agreements
  7. 5.7Japan and the approval of digital therapeutics
  8. 5.8Latin American markets
  9. 5.9Billing and anti-fraud compliance
  10. 5.10Case study: coding a remote monitoring service
  1. 6.1Legal framework for telemedicine in Spain
  2. 6.2Professional liability in teleconsultation
  3. 6.3Electronic prescribing and interoperability
  4. 6.4Data protection in digital services
  5. 6.5Innovation procurement
  6. 6.6Teleconsultation fees and billing
  7. 6.7Authorisation of healthcare centres and services
  8. 6.8Cybersecurity requirements for providers
  9. 6.9Cross-border services in the EU
  10. 6.10Workshop: tender specification for a remote monitoring service
  1. 7.1Integrated evidence generation plan
  2. 7.2Value proposition by payer type
  3. 7.3Value-based pricing
  4. 7.4Risk-sharing contracts
  5. 7.5Stakeholder and influence map
  6. 7.6Negotiation with health services
  7. 7.7Pilots and scaling within the public system
  8. 7.8Adoption and usage indicators
  9. 7.9Regulatory and reimbursement risks
  10. 7.10Workshop: market access plan for three markets
  1. 8.1Description of the digital service
  2. 8.2Qualification and regulatory classification
  3. 8.3Clinical and economic evidence plan
  4. 8.4Economic and budget impact model
  5. 8.5Reimbursement strategy by country
  6. 8.6Implementation plan
  7. 8.7Risk analysis
  8. 8.8Timeline and budget
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

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.

Accredited laboratories(EN ISO/IEC 17025) with rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-oriented master's thesis:safety case, test plan, compliance dossier and operational limits.
Industry mentoring:faculty with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, cyber-OT, DIH and compliance as core pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Description of the digital service

Describe the digital health ecosystem and its stakeholders.

Qualification and regulatory classification

Classify healthcare software under the MDR.

Clinical and economic evidence plan

Apply health technology assessment to digital services.

Economic and budget impact model

Compare reimbursement models in Europe.

Reimbursement strategy by country

Analyse reimbursement pathways in the United States and other markets.

Career opportunities

Where this takes you

Market access specialistRegulatory affairs consultantHealth economics analystReimbursement managerDigital health product managerHealth technology assessment officer
Admissions & scholarships

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.

FAQ

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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