Clinical information systems are applications of standalone software that manage patient data and support clinical processes.
Content
On this page, you will find a short introduction and references to relevant articles.
- Examples of clinical information systems
- Functions of clinical information systems
- Regulatory requirements
- Support for manufacturers and operators
1. Examples of clinical information systems
Hospitals, doctors’ offices, and other healthcare providers such as hospitals use clinical information systems, such as:
- Hospital Information Systems (HIS)
- Medical Practice Management Systems
- Patient Data Management Systems (PDMS)
- Operating Room Management Systems (OMS)
- Laboratory Information (Management) Systems (LIS or LIMS)
- Radiology Information Systems (RIS)
- Nursing Information Systems
Whether Picture Archiving and Communication Systems (PACS) still count as clinical information systems is debatable. This is not the case for systems without a direct patient reference, such as pure drug information and management systems and Critical Incident Reporting Systems (CIRS).
2. Functions of clinical information systems
Clinical information systems support the …
- documentation of medical/clinical data such as medical histories, findings, diagnoses, therapies, etc.
- collaboration, workflow, and clinical processes
- decision-making, e.g., in the selection of therapies
- communication between healthcare professionals and patients
3. Regulatory requirements
a) Qualification of information systems as medical devices
Whether clinical information systems qualify as medical devices depends on their intended purpose. This article on the qualification and classification of standalone software assists with qualification.
An ECJ ruling on “software modules” has allowed declaring only parts of clinical information systems as medical devices. This article examines whether a HIS is to be understood as a system or procedure pack within the meaning of the MDR.
b) General safety and performance requirements
All medical devices must meet the general safety and performance requirements. This also includes the requirements for interoperability.
c) Particular requirements for operators
Operators should ensure they do not inadvertently turn information systems into medical devices during configuration and parameterization.
In-house manufacture of such information systems within Article 7 MDR is generally not permitted if similar devices (CE-marked) are available on the market.
Operators of information systems that are medical devices must also comply with the Medical Device Operator Ordinance (Medizinprodukte-Betreiberverordnung -MPBetreibV).
4. Support for manufacturers and operators
Do you still have questions about the qualification and classification of clinical information systems? Then, please take advantage of our free micro-consulting service.
Our software and regulatory affairs experts support manufacturers and operators of these information systems in meeting regulatory requirements during development, operation, and post-market surveillance without unnecessary effort.
Contact us; the team looks forward to hearing from you!
PDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides 1. PMDS: Functionalities and requirements Patient data management systems (PDMS)…
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