Digital health software and systemslinor2020-08-12T10:16:41+00:00
Software & systems in the digital health field
heat, based on products that use software and algorithms, be it patient records and analysis, clinical trial data analysis software, artificial intelligence, machine learning, image processing, sound processing and more.
All digital healthcare products, collect, analyze, store and manage data, using these and other software systems.
Therefore, the area of integrity and reliability of the data obtained from software used is fraught with many risks because the product is used to treat patients and is also used by doctors and medical staff as well as among home users, any wrong decision may end in wrong treatment / non-treatment And even get into situations of loss of life. Therefore, data obtained from digital health systems and products must be accurate, reliable, controlled, complete, throughout the life of the product.
Understanding the regulatory requirements of each target market, performing risk analysis, confidentiality, privacy protection and confidentiality of medical information, data integrity, and validation will be required as part of conducting regulatory reviews of the various regulatory bodies such as ISO 13485, ISO 27001, ISO 27799, MHRA, FDA and – CE and will also require the registration of the product.