Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Monitoring, ePRO and Patient Data

800-hour online Postgraduate Diploma in Monitoring, ePRO and Patient Data. 8 modules covering Regulation (EU) 2017/745 (MDR), IEC 60601-1-11 (home-use equipment) and REDCap. Dedicated tutor and open enrolment.

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

What you will be able to do

01

Design remote monitoring programmes for chronic patients.

02

Select devices and sensors according to clinical and regulatory requirements.

03

Implement the capture of patient-reported outcomes.

04

Clean and process physiological data from wearable sensors.

05

Configure alert rules using clinical criteria.

06

Integrate patient data with the electronic health record using standards.

07

Apply privacy and governance principles to health data.

Profile

Who it's for

  • Remote monitoring programme manager looking to specialise in Monitoring, ePRO and Patient Data.
  • Clinical data scientist looking to specialise in Monitoring, ePRO and Patient Data.
  • Connected device engineer looking to specialise in Monitoring, ePRO and Patient Data.
  • ePRO specialist looking to specialise in Monitoring, ePRO and Patient Data.
  • Health data protection officer looking to specialise in Monitoring, ePRO and Patient Data.
  • Telemedicine coordinator looking to specialise in Monitoring, ePRO and Patient Data.
  • Engineering or science graduates looking to enter digital health.
Standards & tools

What you'll work with

  • Regulation (EU) 2017/745 (MDR)
  • IEC 60601-1-11 (home-use equipment)
  • ISO/IEEE 11073 (personal health device communication)
  • HL7 FHIR
  • IEC 62304 (medical device software lifecycle)
  • Regulation (EU) 2016/679 (GDPR)
Syllabus

8 modules · 800 h

  1. 1.1Telemonitoring and telemedicine models
  2. 1.2Candidate chronic conditions: HF, COPD and diabetes
  3. 1.3Hospital at home and early discharge
  4. 1.4Evidence of telemonitoring effectiveness
  5. 1.5Care pathways and clinical roles
  6. 1.6Alert management and alarm fatigue
  7. 1.7Connectivity and logistics requirements
  8. 1.8Patient and carer experience
  9. 1.9Funding and reimbursement models
  10. 1.10Case study: telemonitoring programme for heart failure
  1. 2.1Connected blood pressure monitors, pulse oximeters and scales
  2. 2.2Continuous glucose monitors
  3. 2.3ECG patches and Holter monitors
  4. 2.4Activity and sleep wearables
  5. 2.5Implantable sensors and cardiac devices
  6. 2.6Clinical validation of devices
  7. 2.7Accuracy versus consumer grade and battery life
  8. 2.8Connectivity: Bluetooth LE, NB-IoT and gateways
  9. 2.9MDR classification of devices
  10. 2.10Laboratory: reading data from a BLE pulse oximeter
  1. 3.1PROMs in routine clinical practice
  2. 3.2Electronic symptom diaries
  3. 3.3Computerised adaptive questionnaires
  4. 3.4Frequency and timing of capture
  5. 3.5Integrating PROMs into the consultation
  6. 3.6Symptom-based alerts
  7. 3.7Compliance and reminder strategies
  8. 3.8Accessibility and the digital divide
  9. 3.9Validity of the electronic version
  10. 3.10Practice: designing an ePRO workflow in oncology with alerts
  1. 4.1Preprocessing of physiological signals
  2. 4.2Detection of artefacts and outliers
  3. 4.3Missing data and intermittent use
  4. 4.4Resampling and temporal aggregation
  5. 4.5Features derived from time series
  6. 4.6Data quality according to ISO 8000
  7. 4.7Clinical labelling of events
  8. 4.8Metadata and provenance
  9. 4.9Time-series storage
  10. 4.10Laboratory: cleaning a wearable heart rate series
  1. 5.1Clinical threshold rules
  2. 5.2Individualised anomaly detection
  3. 5.3Predictive models of decompensation
  4. 5.4NEWS2 early warning scores
  5. 5.5Validation of predictive algorithms
  6. 5.6Bias and fairness in algorithms
  7. 5.7Explainability for clinicians
  8. 5.8AI software as a medical device
  9. 5.9Assessment of clinical impact
  10. 5.10Practice: readmission prediction model using monitoring data
  1. 6.1HL7 FHIR standards for observations
  2. 6.2IHE profiles for personal devices
  3. 6.3IEEE 11073 standard
  4. 6.4LOINC and SNOMED CT terminologies
  5. 6.5Integration with the electronic health record
  6. 6.6Commercial telemonitoring platforms
  7. 6.7Apple Health and Google Health Connect APIs
  8. 6.8European Health Data Space
  9. 6.9Secondary use of data for research
  10. 6.10Workshop: mapping home measurements to FHIR Observation
  1. 7.1GDPR and special category data
  2. 7.2Data protection impact assessment
  3. 7.3Consent and legal bases
  4. 7.4Pseudonymisation and anonymisation
  5. 7.5Cybersecurity of medical devices IEC 81001-5-1
  6. 7.6Access control and auditing
  7. 7.7Clinical data governance
  8. 7.8Clinical responsibility in monitoring
  9. 7.9Communicating risks to patients
  10. 7.10Case study: DPIA of a home monitoring programme
  1. 8.1Selection of population and condition
  2. 8.2Design of the care pathway
  3. 8.3Selection of devices and PROMs
  4. 8.4Data architecture and integration
  5. 8.5Design of alert rules
  6. 8.6Privacy and security plan
  7. 8.7Programme evaluation plan
  8. 8.8Testing with simulated data
  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 a dedicated technical tutor. No fixed timetable: students progress at their own pace within the intake, making it possible to combine with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is REDCap, Apple ResearchKit, Python (pandas), Grafana, Power BI, in free, academic or evaluation versions. Trials are studied using real procedures from home remote monitoring pilots, validation of wearable sensors against clinical reference, and adherence analysis of ePRO questionnaires. Assessment is continuous by module plus the final integrating project.

Laboratories eligible for accreditation(EN ISO/IEC 17025) with a rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-focused Master's Thesis:safety case, test plan, compliance dossier and operational limits.
Industry mentoring:lecturers with track records 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, with OT cybersecurity, DIH and compliance as its pillars.
Capstone project

Build it end to end

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

Selection of population and condition

Design remote monitoring programmes for chronic patients.

Design of the care pathway

Select devices and sensors according to clinical and regulatory requirements.

Selection of devices and PROMs

Implement the capture of patient-reported outcomes.

Data architecture and integration

Clean and process physiological data from wearable sensors.

Design of alert rules

Configure alert rules using clinical criteria.

Career opportunities

Where this takes you

Remote monitoring programme managerClinical data scientistConnected device engineerePRO specialistHealth data protection officerTelemedicine coordinator
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme software.
  • Sufficient Spanish to follow technical regulatory texts.

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 a week on average, compatible with a full-time job.

The programme works with REDCap, Apple ResearchKit, Python (pandas), Grafana 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 on passing the continuous assessment and the integrating project. It is in-house training, not an official Ministry-recognised qualification.

Yes. Modules passed in a course or Postgraduate Diploma in the same area are credited towards the advanced programme. Consult the credit transfer policy when you enrol.

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