Mobile health devices and applications make it possible for clinicians to monitor patients’ health on a day-to-day basis, regardless of their physical location. These technologies can greatly improve care for patients who are not well-served by the traditional healthcare system. Healthcare providers do, however, need to consider regulatory and privacy concerns as they adopt mobile health.
Product regulations have undergone significant changes in developed economies during the last decade. If your health care business offers any kind of mobile devices or applications, you may need licences and permits from the federal, provincial and municipal levels of government.
Through Certify Health Products, KI Design works with clients to assess the privacy and security safeguards/measures of digital health products, such as mobile health applications and devices. We draw on our wide-ranging expertise in Canadian, American and European legislation and standards to help develop privacy policies and governance. Our consultants are available on call to advise on certification decision-making, and to provide corporate training on new legislative changes that may impact the distribution of your health products. Further, KI Design can help you to maintain proper distribution records, have proper procedures for product recalls and ensure that you meet the appropriate manufacturing and practice requirements. We provide advice on standards that help support medical-device interoperability and cyber security. Our consultants are members of IEEE, which delivers a suite of standards for medical-device communication.
- Help healthcare product vendors and integrators create interoperable and secure devices and systems
- Help healthcare providers procure secure devices for disease management, health and fitness, and independent living that can help save lives and improve quality of life
- Provide advisory on enabling interoperable communication for traditional medical devices, as well as personal health devices
- Provide recommendations on risk-management standards
- Ensure application of interoperability standards & cyber-security standards
- Assist manufacturers electing to declare conformity with consensus standards to meet specific requirements for the creation of medical devices