Intended use, quality, security and regulatory registrations
CareSimple is built and operated to medical-device standards. Here is how our platform is intended to be used, and the certifications and registrations that govern it.
Intended conditions and patient population
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. CareSimple 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 & security
Our quality compliance assurance program covers the identification, assessment, correction and monitoring of the aspects that enhance the quality of CareSimple and its related services. It establishes and maintains the requirements for developing and manufacturing a reliable medical device, in conformity with the regulatory requirements of each jurisdiction where the platform is deployed.
In 2020, CareSimple obtained ISO 13485:2016 certification, the recognized quality management system standard for medical devices. Compliance is validated through management review, internal and external audit, employee training, risk control, and analysis of data (KPIs).
CareSimple operates under a rigorous Information Security Management System (ISMS), a framework of policies and procedures covering all legal, physical and technical controls involved in an organization's information risk management processes. ISO 27001 certification was obtained in 2020.
We hold to the highest standards of information security management, guided by a set of security objectives: protect privacy, ensure integrity, constantly improve, plan & manage, be recognized, and assess & review.
HIPAA
CareSimple is built to support compliance with the U.S. Health Insurance Portability and Accountability Act (HIPAA). When CareSimple processes protected health information (PHI) on behalf of a covered entity, it does so as a Business Associate under a signed Business Associate Agreement (BAA).
Our platform implements the administrative, physical, and technical safeguards required by the HIPAA Security Rule, including role-based access controls, audit logging, encryption of PHI in transit and at rest, workforce security training, and breach-notification procedures. These controls are maintained within the same ISO 27001-certified Information Security Management System described above.
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.
United States
Food and Drug Administration
Canada
Health Canada
Questions about compliance
For questions regarding our quality, security, privacy or regulatory posture, including certificate requests and security documentation for procurement, reach out to our team.
Need our security and compliance documentation?
We routinely support health-system and payer procurement reviews with certificates, security questionnaires, and integration documentation.