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Things to Consider When Determining the Regulatory Requirements for Software

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are developing software aimed at health care systems, hospitals, physicians, and lay-users for various levels of use, from assisting diagnoses in a clinical environment to tracking exercise and general health indicators in the home. In particular, a growing number of companies are focusing on the development of digital therapeutics - a class of software devices that deliver and monitor medical interventions for the purpose of treating, managing, or preventing certain diseases or conditions - for use in a patient’s home.


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