Peculiarities of Software for Medical Devices
Many critical functions carried out by medical devices are directed by software, and because software is not a visible product, sometimes, medical devices manufacturers lose sight of its importance.
Obviously, software can be considered a medical device, an accessory to a medical device or as a component that is a built in part of a medical device in the same class as the medical device.
The function of the software leads the classification of the software medical device. If this software is a medical device, it may be classified as Class I; however, if the software medical device is an built in component of a device, it assumes the classification of the device.
Applications for any purpose must be developed using FDA guidelines. An application designed to comply with the technical guarantees of the HIPAA is classified as an FDA Class I applications, which controls configuration management, such as monitoring and physical environmental security. Adherence to security and privacy will only grow in importance as hackers broaden their targets to include medical devices and software.
Many healthcare organizations and their vendors have started using cloud managed services to increase security and privacy services. These can reduce the initial risk assessment of the IT infrastructure that develops your applications, and change the impact on privacy, the software development lifecycle by using a cloud environment that exceeds HIPAA, GAPP and other security and privacy controls.
Vendors and developers need to secure their applications regardless of whether or not they obtain FDA classification. There are too many violations today and too much on the line when these gaps occur. Nevertheless, if you're ready to meet FDA Class I requirements, migrating your applications to a HIPAA-compliant managed cloud can ease the process.
It is important for medical device manufacturers to select software designers and developers who have well-established risk management systems, as they will be able to meet IEC 62304 standards.
Archer Software provides depth expertise in system analysis, planning, and prototyping management solutions for healthcare organizations. We can help your company by creating a central dashboard based on your unique metrics, or reformatting patient data like treatment details, appointment history, medications, specialists’ comments, and lab results like CBC, HCT, Hg and others according to HL7 and CCD standards, which are fully compliant with HIPPA.
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