Clinical Decision Support Systems – Software as a Medical Device

ORTEC Logiqcare is a legal manufacturer of Software as a Medical Device compliant with the Medical Device Regulation (MDR). OurClinical Decision Support Systems (CDSS)aid healthcare professionals by enabling personalized medicine in clinical practice.

We actively collaborate with academic medical centers and research groups to developnew medical devices. Our aim is to implement high-quality and scientifically validatedprediction models, preferably supported by medical guidelines.In combinationwith our LogiqSuitemedical data management platform, we foster innovation throug Continual Learning and Improvement.

Key benefits

1. Support healthcare professionals in patient care

Wesupport healthcare professionals in patient care with Clinical Decision Support Systems(CDSS) byimplementingscientifically validated prediction models,for exampleto calculate individual risks and evaluate the effect of treatment. Our systems facilitate shared decision-making between patients and healthcare professionals and are compliant with the applicable regulations.

2. Top quality products

We are committed to deliverquality products based on scientific evidence. Our products are the result of collaboration between care professionals, medical scientists, data scientists, software developers, and legal experts. Our products are monitored in real-time, built according to state-of-the-art, and compliant with the Medical Device Regulation (MDR), standardsfor information security (ISO27001, NEN7510).For more information about compliancego to: Compliance.

3. Integrated solutions

Our solutions facilitate datacommunication with electronic health records (EHR) and can be embedded in the EHR. This makes it possible to pre-populate the CDSS with patient data from the EHR and export data and results to the EHR or data management systems used for care and research like our MDM solution LogiqSuite.

Additional information

Collaboration ensures the required quality in Clinical Decision SupportSystems!

Applying Clinical Decision Support Systems (CDSS) in clinical care requires a foundation of trust among healthcare providers and patients. The use of AI for diagnosis and treatment is often met with skepticism. Therefore, it is essential for scientific research to rigorously validate the prediction models utilized, ensuring their quality and reliability.Resulting in static algorithms.Due to MDR restrictions to ensure patient safety, learning or dynamic algorithms cannot be supported in CDSS.

Although ORTEC Logiqcare originated within a data science company, we chose from the beginning toclosely collaborate with academic research groups for the development of our CDSS. We believe that combining medical academic expertise with our strengths in data science, software development, and knowledge of applicable regulationsallows us to effectively translate scientific prediction models into solutions forclinical practice, thereby ensuring the highest quality of patient care.

Financing the use of Clinical Decision Support Systems leads to better and cheaper care

Even when the quality and usability of a medical device is obvious, it does not automatically lead to successful implementation in clinical care.

Our medical devices

U-prevent is a clinical decision support system for the application of risk prediction models in clinical practice. The risk prediction calculators have been developed to determine an individual risk profile of developing cardiovascular disease and to analyze the effects of selected lifestyle andtreatment options. Supporting a shared decision-making process and providing patients with a better understanding of their risk and treatment options to lower that risk.

Join the more than 15.000 healthcare professionals with a registered U-Prevent account at www.u-prevent.com

The LIFE HF prediction model enables estimation of lifelong overall and Heart Failure (HF) hospitalization-free survival, and (lifetime) treatment benefit for individual patients with Heart Failure with Reduced Ejection Fraction (HFrEF). It serves as an instrument to improve the management of HFrEF by facilitating personalized medicine and shared decision-making.

Currently, this is a feasibility testdevice under evaluation.

VTE Predict estimates individual risks of a new venous thrombo-embolism (VTE) in secondary prevention, i.e., after a primary event. It helps physicians and doctors with shared decision-making about stopping, changing or continuing anticoagulation medication after thrombosis, balancing the risks of recurrent VTE and bleeding

Currently, this is a feasibility test device under evaluation

The Stroke Triage App (STA)advises paramedics on the type of hospital a patient with suspected stroke should be transported to.Based on a personalized predicted prognosis the substantiated transportation advice aims to minimize interhospital transfers, thereby decreasing the average time to treatment for patients and increasing the probability of good outcome.

Biologicalsfor rheumatoid arthritis patients are usually tapered at the risk that rheumatic symptoms will reappear. Such a flare can be treated by increasing the dose of medication, with negative effects for the patient. TAPER uses a prediction model to analyze the patient’s risk when tapering medication, thereby reducing the likelihood of flares.

Currently, this is an investigational device under evaluation in a trial.