With growing cross-linking in the digital healthcare sector and the possibilities of medical simulation in combination with high-performance computing for cloud-based healthcare software solutions, medical software is playing an increasingly important role in mobile health and supports the approach of personalized medicine.
What is the definition of medical software? Which software solutions belong to the medical software category?
Medical software refers to software solutions that are used in the practice of management medicine.
A distinction is made in medical software between embedded software and stand-alone software. Embedded software is an integral part of an existing medical product.
The stand-alone software is itself an independent medical product. The third option is software as an accessory of a medical device.
The first two definitions are not explicitly differentiated in the MDR, but there are implicit differences, e.g., in validation.
For stand-alone software, verification and validation of the software are necessary.
Only practice management software and remote patient monitoring software must be verified for software that is part of an existing medical device, as only the entire product needs to be validated.
In 2016, IEC/CD1 82304-1 Health Software – Part 1: General Requirements for product safety was published.
The standard describes the requirements for product safety (SAFETY), information security (SECURITY), usability (USABILITY), and instructions for use (INSTRUCTION FOR USE).
It requires adherence to a software development process and references IEC 62304/A1:2015.
IEC 62304 has become the standard for developing medical device software in the EU and the US, whether or not the software solution is standalone.
The following terms are distinguished:
- HEALTH SOFTWARE: Software specifically designed to maintain or improve individuals’ health or provide care.
- MEDICAL SOFTWARE: Software specifically intended for use in a physical medical device or intended to be a SOFTWARE medical device.
- SOFTWARE MEDICAL DEVICE: Software that is intended to be a stand-alone medical device.
- MEDICAL DEVICE SOFTWARE: Software that is specifically intended to be incorporated into a physical medical device.
What classifications are there for medical software?
Whether software qualifies as a medical device is determined by the manufacturer’s intended purpose for the software.
If this corresponds to the definition of the term “medical device” according to Article 2 of the Medical Device Regulation (MDR), the software is designated as a medical device.
The functions of the software do not play a decisive role. Article 2 (1) of the MDR defines which products will be classified as medical devices.
For example, an app for analyzing cardiac performance may be intended as a fitness tracker and is therefore not considered a medical device.
However, if the app assists a patient’s appointments a cardiologist with diagnostics remote patient monitoring, the software will be evaluated as a medical device.
If the medical software is to be classified as a medical device, one must deal with the risk classification.
Here, the MDR distinguishes 4 risk classes: I, IIa, IIb, and III.
Basically, the following statement can be made: The greater the potential harm caused by the use of medical devices and practice management systems and software in healthcare and medical practices itself, the higher the risk class tends to be.
For example, software that supports decisions on a patient’s therapy and diagnostics or monitors remote patient monitoring physiological processes already falls at least into class IIa.
Medical billing software companies and healthcare providers should follow Rule 11 of the current MDR to classify medical billing software properly.
In summary, the medical software manufacturer must take into account that they are responsible for deciding whether the software is a medical device or not.
The responsibility for the classification or correct classification into a risk class also lies with the medical device manufacturer.
This must be done very carefully, as in the worst case, certification of medical professionals by the notified bodies may be prevented or the medical device may even have to be subsequently withdrawn from the market.
- Helpful support can be found in the Guide to Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_11_guidance_qualification_classification_software_en.pdf
Additional guidance can be found by medical software companies here:
- MDCG 2021-24 – Guidance on classification of medical devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
There is currently discussion about an EU AI regulation that could soon become part of the regulatory requirements for medical device manufacturers.
This includes medical software developed using machine learning and/or logic and knowledge-based/statistical approaches that can produce results for a set of human-determined goals.
These may include, for example, predictions, recommendations, or support for specific decision-making processes medical practices that affect mental health or the patient care environment.
The decision is expected to be adopted in 2022.
Medical devices, healthcare apps, and medical facilities, particularly medical software, will be classified as high-risk AI in practice management in this regard.
For these high-risk AI products with medical history, requirements increase in the following areas:
- Post-market monitoring and market surveillance.
- Information requirements
- Risk management
- Data requirements, especially training data
- Technical documentation
- Automatic logging
- Human supervision
- Accuracy, robustness, and cybersecurity
- Registration of AI in EU databases
It is likely that the decision would thus also have a direct impact on the classification of medical device and software vendors.
What are the advantages of Simq’s software solutions? What distinguishes Simq’s medical software solutions?
Simq’s medical software solutions are all developed to keep medical staff to the highest standards.
Simq is a certified simulation and software manufacturer according to ISO 13485 in the field of medical and medical technology and follows the IEC 62304 standard when developing innovative software solutions, thus meeting the requirements of the EU MDR (Medical Device Regulation) for daily clinical use.
The medical software solutions are developed in close cooperation with universities, physicians, healthcare companies, and medical device manufacturers.
We place particular emphasis on verifying and validating the medical software, for example, by means of elaborate test series or patient studies.
Depending on the intended purpose, we can also develop software based on our Simq platform that is not classified as a medical device.
What else should you know about medical software?
From a regulatory perspective, the same requirements are placed on medical software as on a physical medical device. Accordingly, medical software must meet the highest quality standards.
Medical software is not to be confused with personal or electronic health record software or apps. Thus, the MDR describes that personal or electronic health record software, when used for general purposes or from the areas of practice management of lifestyle and well-being, is not a medical device.
What else should you know about Simq?
Simq is a certified simulation service provider and software manufacturer in the field of patient scheduling and bed management of medical facilities and medical technology in the healthcare industry and is one of the healthcare companies and pioneers of in silico medicine.
Simq products, digital healthcare software apps, solutions, and services enable medical device manufacturers, physicians, and medical staff to practically apply numerical simulation and use it for more effective, safer, and personalized patient care.
Simq is committed to the standardization and broader application of in silico medicine through the Avicenna Alliance to further patient outcomes and ensure patients access to safe, affordable, and cost-effective healthcare.
Medical software FAQs
Medical software is designed for healthcare use. It helps practitioners, patients, and administrators with care, diagnosis, treatment, management, and education. It improves procedures, patient care, and research.
A distinction is made between the following types of healthcare software categories: Health Software, Medical Software, Medical Device Software, and Medical Device Software.
According to the classification rules, medical devices are divided into four risk classes according to the manufacturer’s intended purpose.
Regulatory authorities and developers use risk classes to determine the necessary level of scrutiny and controls for different types of software. The International Medical Device Regulatory Framework, particularly the International Medical Device Standard ISO 14971, provides the most widely used classification system for assessing the risk of medical software.
According to this standard, medical software is divided into four risk classes:
Class I includes low-risk medical software that is unlikely to cause serious harm or injury to patients. These software tools typically have a basic purpose and limited interaction with patients or healthcare providers. Examples might include general health and wellness apps, simple medical calculators, and basic patient education software.
Class IIa: Software in this class poses a moderate risk to patients. It might involve more complex software that’s used for diagnosis or treatment but still has a relatively low potential for harm if used improperly. Many types of software used for monitoring and data collection fall into this category, such as basic electronic health records (EHR) systems or medical imaging software that provides simple analyses.
Class IIb: Higher-risk software falls into this class. It includes software that’s involved in critical diagnosis, treatment planning, or monitoring of patients. These software types have a higher potential to cause harm if they malfunction or are used incorrectly. For instance, complex EHR systems, advanced medical imaging software with significant diagnostic capabilities, and certain clinical decision support tools might be classified as Class IIb.
Class III: This is the highest-risk class for medical software. It includes software that’s directly used for diagnosing, treating, or monitoring serious medical conditions where incorrect results or malfunction could lead to serious harm or death. Examples might include software used to control life-supporting or life-sustaining equipment, complex clinical decision-support tools, and software that’s integrated into implantable medical devices.
Basically, the greater the potential damage, the higher the risk class.
Since an AI regulation is currently being debated and medical software is classified as high-risk AI in it, the decision will directly impact the risk classification.
Simq’s medical software solutions are highly regarded for their superior quality standards, which makes them an excellent choice.
Furthermore, Simq complies with the EU MDR (Medical Device Regulation) requirements in medical and medical technology.
The quality features of the software are confirmed by several certifications that include simulation, hospital management, operations management, and manufacturing software.
These certifications serve as a testament to the software’s ability to deliver optimal performance in their respective fields.
The software has proven to be reliable, efficient, and effective in meeting the needs of its users. Its various certifications clearly indicate the software’s ability to deliver optimal results for its intended purpose.
Medical records and software must meet the highest quality standards because they have the same regulatory classification as physical medical devices.
They cannot be compared to fully electronic health record systems, software, or apps.
Simq is a leader in the field of in silico medicine, constantly seeking new ways to enhance patient care.
We strive to promote the use of cutting-edge technologies and offer consulting and development services to medical device companies.
Our software solutions are designed to assist healthcare providers, doctors, and their patients in achieving the most effective diagnosis and treatment possible.