SOFTWARE Act

Summary: Sensible Oversight for Technology which Advances Regulatory Efficiency Act or the SOFTWARE Act This bill amends the Federal Food, Drug, and Cosmetic Act to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components, and is for:  administrative or operational support or the processing and maintenance of financial records; use in clinical, laboratory, or administrative workflow and recordkeeping; managing data but not for active patient monitoring or controlling the functions of a connected medical device; organizing and presenting information for health or wellness education or maintaining a healthy lifestyle; or analyzing information to provide general health information or patient-specific recommendations.  The FDA must classify an accessory of a medical device independently from the medical device with which it is used. Health software is exempted from regulation by the FDA (including as a medical device), except for software that provides patient-specific recommendations and poses a significant risk to patient safety. The FDA must review existing regulations and guidance regarding the regulation of health software.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sensible Oversight for Technology 
which Advances Regulatory Efficiency Act'' or the ``SOFTWARE Act''.

SEC. 2. HEALTH SOFTWARE.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(ss)(1) 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--
                    ``(A) is intended for use for administrative or 
                operational support or the processing and maintenance 
                of financial records;
                    ``(B) is intended for use in clinical, laboratory, 
                or administrative workflow and related recordkeeping;
                    ``(C)(i) 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;
                    ``(ii) utilizes a connectivity software platform, 
                electronic or electrical hardware, or a physical 
                communications infrastructure; and
                    ``(iii) is not intended for use--
                            ``(I) in active patient monitoring; or
                            ``(II) in controlling or altering the 
                        functions or parameters of a device that is 
                        connected to such software;
                    ``(D) 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;
                    ``(E) 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
                    ``(F) 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.
    ``(2) The term `accessory' means a product that--
            ``(A) is intended for use with one or more parent devices;
            ``(B) is intended to support, supplement, or augment the 
        performance of one or more parent devices; and
            ``(C) shall be classified by the Secretary--
                    ``(i) according to its intended use; and
                    ``(ii) independently of any classification of any 
                parent device with which it is used.''.

SEC. 3. APPLICABILITY AND INAPPLICABILITY OF REGULATION.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524B. HEALTH SOFTWARE.

    ``(a) Inapplicability of Regulation to Health Software.--Except as 
provided in subsection (b), health software shall not be subject to 
regulation under this Act.
    ``(b) Exception.--
            ``(1) In general.--Subsection (a) shall not apply with 
        respect to a software product--
                    ``(A) of a type described in subparagraph (F) of 
                section 201(ss)(1); and
                    ``(B) that the Secretary determines poses a 
                significant risk to patient safety.
            ``(2) Considerations.--In making a determination under 
        subparagraph (B) of paragraph (1) with respect to a product to 
        which such paragraph applies, the Secretary shall consider the 
        following:
                    ``(A) The likelihood and severity of patient harm 
                if the product were to not perform as intended.
                    ``(B) The extent to which the product is intended 
                to support the clinical judgment of a medical 
                professional.
                    ``(C) Whether there is a reasonable opportunity for 
                a medical professional to review the basis of the 
                information or treatment recommendation provided by the 
                product.
                    ``(D) The intended user and user environment, such 
                as whether a medical professional will use a software 
                product of a type described in subparagraph (F) of 
                section 201(ss)(1).
    ``(c) Delegation.--The Secretary shall delegate primary 
jurisdiction for regulating a software product determined under 
subsection (b) to be subject to regulation under this Act to the center 
at the Food and Drug Administration charged with regulating devices. 
    ``(d) Regulation of Software.--
            ``(1) In general.--The Secretary shall review existing 
        regulations and guidance regarding the regulation of software 
        under this Act. The Secretary may implement a new framework for 
        the regulation of software and shall, as appropriate, modify 
        such regulations and guidance or issue new regulations or 
        guidance.
            ``(2) Issuance by order.--Notwithstanding subchapter II of 
        chapter 5 of title 5, United States Code, the Secretary may 
        modify or issue regulations for the regulation of software 
        under this Act by administrative order published in the Federal 
        Register following the publication of a proposed order.
            ``(3) Areas under review.--The review of existing 
        regulations and guidance under paragraph (1) may include review 
        of the following areas:
                    ``(A) Classification of software.
                    ``(B) Standards for development of software.
                    ``(C) Standards for validation and verification of 
                software.
                    ``(D) Review of software.
                    ``(E) Modifications to software.
                    ``(F) Manufacturing of software.
                    ``(G) Quality systems for software.
                    ``(H) Labeling requirements for software.
                    ``(I) Postmarketing requirements for reporting of 
                adverse events.
            ``(4) Process for issuing proposed regulations, 
        administrative order, and guidance.--Not later than 18 months 
        after the date of enactment of this section, the Secretary 
        shall consult with external stakeholders (including patients, 
        industry, health care providers, academia, and government) to 
        gather input before issuing regulations, an administrative 
        order, and guidance under this subsection.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed as providing the Secretary with the authority to regulate 
under this Act any health software product of the type described in 
subparagraph (F) of section 201(ss)(1) unless and until the Secretary 
has made a determination described in subsection (b)(1)(B) with respect 
to such product.''.

SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE.

    Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended--
            (1) in subparagraph (2), by striking ``or'' after ``or 
        other animals,'';
            (2) in subparagraph (3), by striking ``and'' and inserting 
        ``or''; and
            (3) by inserting after subparagraph (3) the following:
            ``(4) is not health software (other than software 
        determined to be a risk to patient safety under section 
        524B(b)), and''.