91655 - Clinical Engineering and Health Informatics

Learning outcomes

Clinical Engineering: At the end of the course, students will acquire the essential elements of the main patient-monitoring and diagnostic devices. They will also be able to identify the main criteria for the effective and safe management of biomedical equipment within a healthcare facility. In addition, they will develop the ability to understand the technical and functional specifications of systems and methods used in the medical field for prevention, safety, diagnosis, therapy, and rehabilitation.

Medical Informatics: Upon completion of the course, students will acquire the basic skills necessary to operate within a healthcare IT environment, with awareness of clinical standards and regulatory frameworks in digital health. In particular, they will be able to understand healthcare information flows for the collection, processing, communication, and management of clinical data in care delivery, research, and administrative activities. They will be able to manage and interpret different types of healthcare data and standards, and will be able to independently address practical issues related to a healthcare information system, such as the development of software applications and interfaces for interoperability. Moreover, they will acquire basic skills to apply adequate security measures for protecting clinical data and to comply with medical device regulations.

Course contents

Biomedical technologies and medical devices: definition, coding, classification, and certification of medical devices. Main categories of medical devices used today for prevention, diagnosis, and patient treatment. EU Regulation 745/2017.

Risk Analysis.

Evaluation of the performance of a medical device: confusion matrix, sensitivity, specificity, accuracy, PPV, NPV; ROC curve and AUC.

The clinical engineer and biomedical technician: activities and competencies. Management and evaluation of technologies in healthcare facilities, including HTA approaches. Acquisition and maintenance of equipment. Criteria for sizing a Healthcare Service. Regulations to ensure the correct and safe use of biomedical technologies.

Healthcare systems, health legislation, and the organization of national and regional healthcare services.

Healthcare Information Systems.

Electronic Health Record, LIS, RIS, PACS, and BIMS.

Fascicolo Sanitario Elettronico (Personal Health Record).

Telemedicine.

Ecosistema Dati Sanitari and the European Health Data Space.

Digital Health and intelligent systems.

Types of healthcare data: structured and unstructured data, biosignals, bioimages, NGS.

Interoperability: standard formats – HL7 CDA, HL7 FHIR, OMOP, DICOM, FASTQ, EDF – and standard vocabularies – SNOMED CT, ICD, LOINC.

Regulatory and legal aspects: GDPR, primary and secondary uses of clinical data, Privacy and Data Protection, DPIA and technical-organizational measures, certifications, AI Act.

Seminar lectures will be delivered on specific topics by domain experts.

Readings/Bibliography

Course notes and materials provided by the professor.

Optional further reading:

• Manuale di ingegneria biomedicale, Armando Ferraioli, Dario Flaccovio Editore (ISBN 9788857912288)
• Informatica Medica, Alberto Rosotti, McGraw-Hill (ISBN 9788838674846)
• Additional complementary texts and materials for further study will be indicated by the instructor during the course.

Teaching methods

Classroom lectures.

At the end of the course, the professor accompanies students to selected healthcare facilities where, with the collaboration of clinical engineers working in those facilities, some of the diagnostic devices discussed during the course are shown. Students are also introduced to and shown the typical activities performed by clinical engineers in a healthcare setting.

Assessment methods

Assessment is based on the development and presentation of a group project, with an optional oral exam. Students who do not complete or do not pass the group project may take the oral exam.

Teaching tools

Overhead projector, PC, video projector.

Office hours

See the website of Sabato Mellone