Sec. 2241. Health software
346 words·~2 min read·
/bill/114/hr/6/eh/section-2241A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended by adding at the end the following: The term health software means software that does not, through use of an in vitro diagnostic device or signal acquisition system, acquire, process, or analyze an image or physiological signal, is not an accessory, is not an integral part of a device necessary to support the use of the device, is not used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans, and— is intended for use for administrative or operational support or the processing and maintenance of financial records; is intended for use in clinical, laboratory, or administrative workflow and related recordkeeping; is intended for use solely in the transfer, aggregation, conversion (in accordance with a present specification), storage, management, retrieval, or transmission of data or information; utilizes a connectivity software platform, electronic or electrical hardware, or a physical communications infrastructure; and is not intended for use— in active patient monitoring; or in controlling or altering the functions or parameters of a device that is connected to such software; is intended for use to organize and present information for health or wellness education or for use in maintaining a healthy lifestyle, including medication adherence and health management tools; is intended for use to analyze information to provide general health information that does not include patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition; or is intended for use to analyze information to provide patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition.
The term accessory means a product that— is intended for use with one or more parent devices; is intended to support, supplement, or augment the performance of one or more parent devices; and shall be classified by the Secretary— according to its intended use; and independently of any classification of any parent device with which it is used. .
Connectionstraces to 1
Traces to 1 document
U.S. Code