Quality, security and privacy compliance
CareSimple Compliance
INTENDED USE
CareSimple® is intended for non-continuous, mobile and multi-parameter physiologic patient monitoring. Patients using CareSimple report quantitative and qualitative parameters from the following electronic input methods:
- Manual entries;
- Questionnaires;
- Wireless patient medical devices;
- Messaging, audio and video communications.
CareSimple is intended to provide information which is used to support decisions with diagnosis or therapeutic purposes by the Health Care Professional (HCP), but not as the only means to aid in the diagnosis or treatment of a patient.
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CareSimple retrospectively displays the data, user-defined data alerts and system alerts to the HCP. CareSimple also allows the patient to review their data.
CareSimple is not intended to make a diagnosis. CareSimple does not replace the exercise of the knowledge, skills or judgment of any HCP and more particularly, does not replace a diagnostic decision made by an HCP. HCPs using CareSimple are expected to be using it in conjunction with other sources of patient information to support diagnosis or treatment including but not limited to electronic heath records or claims history.
CARESIMPLE IS NOT INTENDED FOR EMERGENCY USE OR REAL-TIME MONITORING. CARESIMPLE IS NOT AN EMERGENCY MEDICAL RESPONSE SYSTEM.
Intended Diseases/Conditions
CareSimple is intended to receive, display and store monitored physiological parameters for patients with chronic diseases or health conditions requiring post-episodic to long term care including but not limited to diabetes, hypertension, dyslipidemia, obesity, congestive heart failure, chronic obstructive pulmonary disease, coronavirus, cancer, inflammatory bowel disease, and pregnancy.
Intended Patient Population
There is no specific intended patient population. It is for use in patients as determined appropriate by the HCP user, and as appropriate or indicated by the given applicable medical device being remotely monitored.
QUALITY
At CareSimple, the quality compliance assurance program refers to the identification, assessment, correction and monitoring of important aspects designed to enhance the quality of CareSimple and its related services. Also, it establishes and maintains set requirements for developing and manufacturing a more reliable medical device and is in conformity with the regulatory requirements in each jurisdiction that the platform is deployed. To comply with such quality requirements, in 2020, CareSimple obtained certification for the ISO 13485:2016, a known quality management system standard for medical devices. Also, to ensure the compliance of this standard there are a few measurable procedures which validates that these requirements are met, i.e., management review, internal and external audit, employee trainings, risk control, and analysis of data (KPIs).
At CareSimple, the quality compliance assurance program refers to the identification, assessment, correction and monitoring of important aspects designed to enhance the quality of CareSimple and its related services. Also, it establishes and maintains set requirements for developing and manufacturing a more reliable medical device and is in conformity with the regulatory requirements in each jurisdiction that the platform is deployed. To comply with such quality requirements, in 2020, CareSimple obtained certification for the ISO 13485:2016, a known quality management system standard for medical devices. Also, to ensure the compliance of this standard there are a few measurable procedures which validates that these requirements are met, i.e., management review, internal and external audit, employee trainings, risk control, and analysis of data (KPIs).
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SECURITY
CareSimple operates under a rigorous Information Security Management System (ISMS) whereas the ISO 27001:2013 certification was obtained in 2020. An ISMS is a framework of policies and procedures that includes all legal, physical and technical controls involved in an organization’s information risk management processes. CareSimple is committed to the highest standards when it comes to information security management. In order to deliver this commitment, CareSimple has a set of security objectives: protect privacy, ensure integrity, constantly improve, plan & manage, be recognized, and assess & review.
CareSimple operates under a rigorous Information Security Management System (ISMS) whereas the ISO 27001:2013 certification was obtained in 2020. An ISMS is a framework of policies and procedures that includes all legal, physical and technical controls involved in an organization’s information risk management processes. CareSimple is committed to the highest standards when it comes to information security management. In order to deliver this commitment, CareSimple has a set of security objectives: protect privacy, ensure integrity, constantly improve, plan & manage, be recognized, and assess & review.
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REGULATORY
Per the FDA 513(g) Request for Information process, CareSimple is classified as a Non-Device-Medical Device Data System (MDDS) and therefore meets current US FDA requirements.
Canada: Health Canada