The new article describes additional aspects related to the regulatory status of the products for electronic healthcare records.
Table of content
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the interpretation of software exclusion criteria. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Electronic Health Records under TGA Regulations
Exclusion 14M pertains to software or a combination of software and hardware that functions as an electronic health record (EHR). This exclusion is relevant to systems intended for use in clinical practice by healthcare providers to manage patient clinical data within or between healthcare facilities.
The exclusion applies provided the EHR is not designed to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision regarding the treatment of a disease, condition, ailment, or defect.
Key Considerations for Classification of EHR Software
In order to determine whether software qualifies for Exclusion 14M, three essential questions must be addressed:
- Does the product function as an electronic health record, regardless of its name or description? The software must serve the purpose of electronically collecting, using, disclosing, or otherwise managing patient clinical data, similar to the role traditionally played by paper medical records.
- Is the product intended for use in clinical practice by healthcare providers to manage patient clinical data within or between healthcare facilities? The primary function of the software should be to facilitate the management of patient-specific data, enabling healthcare providers to document and review patient history, test results, and other clinical information.
- Does the software diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make recommendations or decisions about the treatment of a disease, condition, defect, or ailment? If the software performs any of these functions, it does not qualify for exclusion and must be classified as a medical device under TGA regulations.
Definitions and Specific Cases
According to the guidance, an electronic health record is software designed to electronically collect, manage, and share patient clinical data within or between healthcare facilities. This includes systems known as Electronic Medical Records (EMR) and Electronic Patient Records (EPR).
The primary purpose of EHRs is to replace traditional paper-based records, allowing healthcare professionals to access, update, and manage patient information more efficiently. These records help in reviewing patient history, updating clinical notes, and determining necessary clinical actions such as ordering tests or prescribing medications.
Patient Clinical Data
Patient clinical data refers to information specific to an individual patient’s health, such as cholesterol levels, surgical history, or medication records. This data is distinct from other types of healthcare-related data, such as information about healthcare processes or facilities, or general medical reference materials.
The focus of EHR software is on managing this patient-specific data to support clinical decision-making.
Healthcare Facilities
Healthcare facilities include any professional setting where healthcare services are provided, such as hospitals, general practitioner (GP) clinics, dental practices, and specialized centers like COVID-19 vaccination sites. EHR software is typically deployed in these environments to manage patient data across different care settings.
Software Claims about Diseases, Conditions, Ailments, or Defects
If EHR software performs any of the following functions related to a disease, condition, ailment, or defect, it does not qualify for exclusion under 14M:
- Diagnosis
- Screening
- Prevention
- Monitoring
- Prediction
- Prognosis
- Alleviation
- Treatment
- Making recommendations or decisions about treatment
Excluded and Non-Excluded Examples
The document also provides multiple examples of excluded and non-excluded products used to illustrate the regulatory approach to be followed.
Excluded Example: Basic EHR Software in a GP Clinic
A software system that stores and manages patient data in a GP clinic, such as past test results, prescriptions, and clinical notes, is excluded from TGA regulation if it serves only as a repository and management tool for patient data. The software allows healthcare providers to retrieve, view, and update patient information but does not perform diagnostic or therapeutic functions.
As the software is used solely for information management and does not make clinical decisions or recommendations, it qualifies for exclusion under 14M.
Non-Excluded Example: EHR Software with Diagnostic Capabilities
Software that not only stores and manages patient data but also analyzes that data to identify trends or conditions, such as a module that screens blood pressure readings to detect chronic hypertension, does not qualify for exclusion. Although the software functions as an EHR, it extends its role to include diagnostic functions, which means it must be classified as a medical device under TGA regulations.
The integration of analytical capabilities that inform clinical decisions about patient conditions or diseases moves the software beyond the scope of exclusion 14M.
Conclusion
In summary, Exclusion 14M under TGA regulations is designed to cover software and hardware systems functioning as electronic health records, provided they are used solely for managing patient clinical data within or between healthcare facilities. This exclusion applies as long as the software does not engage in diagnosing, screening, treating, or making recommendations about diseases or conditions. EHR systems that go beyond simple data management and incorporate diagnostic or therapeutic functions do not qualify for exclusion and must be regulated as medical devices. This ensures that only software with a limited scope of use in clinical practice is excluded from the stringent regulatory requirements applied to medical devices.
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