Medical Device Regulation and Standards
- Remote monitoring technology must be on the market, and meet relevant European and International standards. All medical devices must be CE-marked in accordance with Medical Devices Directive or Medical Devices Regulations[i] and should incorporate confirmation of compliance with other relevant harmonised standards[ii] relevant to the clinical application.
- Software which is defined as a Medical Device under the Medical Devices Regulations must be CE-marked to confirm compliance – see New Technologies[iii];
- There must be appropriate structures in place to protect the patient’s privacy, including full compliance with GDPR[iv].
- A DPIA will be required for each remote monitoring solution in each organisation;
- All data and patient information is used in accordance with the Ethics standards of the relevant organisation (eg HSE or acute hospital);
- Patients are appropriately educated in how to use the remote monitoring technology, ideally this will include easily accessible videos, a written patient information leaflet, and if required an on-line personalised training session;
- The patient information leaflet will clarify how often the patient’s data will be reviewed, by whom it will be reviewed, and for how long it will be monitored;
- The patient information leaflet will clarify the hours, during which access to the clinical service is available and what to do outside of those hours in the event of requiring medical assistance or of increased concern about the condition;
- The patient information leaflet should provide guidance on actions to be taken due to technical issues with the remote monitoring technology;
- Procedures must be in place to record clinically relevant details of all clinical interactions with the patient’s remotely monitored data;
- Procedures must be in place to ensure administrative records of all clinical interactions with the patient or patient’s data;
- Implementation of remote monitoring solutions should have a well-developed rationale: for example, the literature reflects their value as a clinical tool, or they are a surrogate for hospital-based monitoring and can be used to support patients in improved self-management, earlier identification of deterioration, or hospital avoidance.
- Clinicians engaged in Remote Patient Monitoring Initiatives must have a working knowledge of the solution, receive appropriate training, education and support, and must be aware of the limitations of devices in terms of performance, use, validation and calibration.
- Prior to implementation of a remote monitoring solution, there must be an agreed, and appropriately documented clinical pathway ensuring clarity around:
- Patient selection criteria - clinical;
- Patient selection criteria – sociotechnical;
- Remote monitoring technology selection;
- Plan for remote monitoring deployment;
- A Service Level Agreement or equivalent should be in place between solution provider and healthcare provider clarifying details of data access and ownership.
- An analysis of how patient data will be captured, stored and accessed should be carried out to ensure all relevant parties have access to up to date patient data;
- Plan for patient information and education;
- Identification of clinical lead;
- Proposed method and frequency of clinical interaction with the patient and patient data;
- A plan for unscheduled patient contact to the clinical service;
- A plan for steps to be taken if data is not available, and/or the patient cannot be contacted;
- Clinical escalation plan;
- Clinical de-escalation plan;
- Plan for clinical records;
- Plan for administrative records;