Digital health technology encompasses many categories, such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalised medicine.
One revolutionary development in digital health technology is software that can perform complex medical functions— software as a medical device (SaMD).
The International Medical Device Regulators Forum (IMDRF) defines the term Software as a Medical Device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
It is critical to emphasise the words “without being a part of.” This implies that the program works independently of any current hardware. SaMD can, however, interface with other medical devices, including hardware medical devices, and other software as a medical device software.
Software used in healthcare facilities that does not have a medical purpose, such as patient databases, pharmacy prescribing software, software that enables clinical communication and workflow, including patient registration, scheduling visits, voice calling, and video calling, or software that encrypts data for transmission from a medical device, is not SaMD.
Software in Medical Device (SaMD) describes software that is a part of another existing device. This would include any software that powers a medical device’s mechanics, remotely controls functionality, processes data, or is otherwise essential to a medical device’s operation.
SaMD can diagnose conditions, suggest treatments, and inform clinical management.
SaMDs are incredibly valuable because of the way they interact with data. Specifically, these applications can process huge amounts of complex data in a matter of moments.
They’re also mobile, portable, cost-effective, and easier to update than the physical devices used by doctors.
Finally, much of the medical device software on the market is always connected to the internet, meaning its creators can adjustadjust devices with real-time feedback.
However, with rapid advancements, constant innovation, and the ongoing adoption of smartphones and tablets, the SaMD landscape is changing rapidly. This is leading to a considerable deficit in critical knowledge around regulatory practices worldwide.
This process can be managed by the sponsor for setting the same expectations when assessing clinical research organizations in the process of RFI(request for information) and/or RFP. Implementing a standard comparison process can provide the same set of questions and scope of work for medical device CROs to respond.
The Industry Research group forecasts that the global SaMD Size estimated at USD 1048.00 million in 2021 is projected to reach USD 10190.00 million by 2028, exhibiting a CAGR of 38.39% during the forecast period.
Medical software and potential applications can pose challenges for regulatory oversight, classification, intended use and operation instructions guided by highly precise wording. Same SaMD application may have different risk classifications in the EU, U.S., or other countries. Therefore, it is essential to correctly apply the regulatory requirements for risk classification and applicable guidelines to classify the SaMD in each jurisdiction separately.
While it is unrealistic to expect regulatory harmonisation any time soon, the International Medical Device Regulatory Forum (IMDRF) continues its efforts to provide guidelines for better regulatory convergence. During the September 2022 IMDRF meeting in Sydney, Australia, the SaMD Working Group reported that it published four technical documents from 2013-2017 on critical definitions, risk classification, application of quality management systems and clinical evaluation. The SaMD WG will continue to improve international alignment and increase the granularity of its guidance documents.
SaMDs are incredibly valuable because of the way they interact with data. Specifically, these applications can process huge amounts of complex data in a matter of moments.
They’re also mobile, portable, cost-effective, and easier to update than the physical devices used by doctors.
Finally, much of the medical device software on the market is always connected to the internet, meaning its creators can adjust devices with real-time feedback.
However, with rapid advancements, constant innovation, and the ongoing adoption of smartphones and tablets, the SaMD landscape is changing rapidly. This is leading to a considerable deficit in critical knowledge around regulatory practices worldwide.
SaMDs are incredibly valuable because of the way they interact with data. Specifically, these applications can process huge amounts of complex data in a matter of moments.
They’re also mobile, portable, cost-Manufacturers under SaMD will collect the user’s personal data, further including health data. Thus, the bridges between GDPR and MDR are numerous.
Indeed, the SaMD will have to respect the fundamental principles of the GDPR, including privacy by design and privacy by default. This means that the principles of the GDPR must be considered from the design of the SaMD and that these principles must be applied throughout the life of the software. Indeed, no user intervention must be necessary tocomply with the GDPR, i.e., only the necessary data must be collected, the retention period must be determined and respected, and the extent of data processing must be determined, and in its accessibility.
In addition, the collection of health data must also be considered, especially due to its sensitive nature. Health data are data that directly provide information on the health status of the user, but also the combination of several data to arrive at the same result, or a health data by destination.
In principle, the processing of health data is prohibited by the GDPR. Still, there are exceptions, according to article 9.2 of the GDPR, including explicit consent, safeguarding the vital interests of the person, the processing carried out by an association or other non-profit organisation, data made public by the data subject, to establish, exercise or defend a legal claim, important public interest reasons, obligations related to labourlabour law, social welfare, social security, preventive medicine, medical diagnosis, health or social care or management of health care systems and services, public interest reasons in the field of public health, scientific research, archival or statistical purposes.
If SaMD is collecting health data for scientific research, there are two options:
In any case, a privacy impact assessment will have to be carried out by the data controller.
An intelligent digital platform for hospital pharmacists.
An intelligent digital platform for hospital pharmacists. Facilitating the analysis and control of medical prescriptions and the detection of iatrogenic risk situations.
The sponsor required a route to European market access. ECLEVAR MEDTECH created the clinical development strategy and the regulatory strategy to obtain the CE mark.
· Identify the clinical endpoints
· Set up quality system
· Set up a clinical evaluation report
ECLEVAR MEDTECH is supporting SaMD companies to navigate the regulatory pathways. A practical case study on how Eclevar helped a sponsor achieve their CE mark is described above.
Subscribe to our newsletter
VISIT US
ECLEVAR FRANCE:
231 rue Saint-Honoré, 75001 Paris, France
ECLEVAR GMBH
ERFURT, Erfurt Hauptbahnhof
4th, 5th floor
Bahnhofstr. 38 Erfurt 99084
ECLEVAR Australia
Umina Beach NSW 2257, Australia
ECLEVAR UK Limited
3rd Floor 207 Regent Street, London, W1B 3HH
CONTACT US
