,,ii ,calendar ,no4 #dji #aadth ,,congress #b;d ,session ,s4 #aaja ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bg1 #bjae,mr4 ,bennet 7for himself and ,mr4 ,hatch7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,april #d1 #bjaf,reported by ,mr4 ,alexander1 with an amendment and an amendment to the title,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for the regulation of patient records and certain decision support software4 #a4 ,short title ,this ,act may be cited as the ,medical ,electronic ,data ,technology ,enhancement for ,consumers' ,health ,act or the ,,medtech ,act4 #b4 ,regulation of medical software ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7o7 ,regulation of medical and certain decision support software 7#a7 ,exclusions from the category of devices ,the term device1 as defined in section #bja7;h71 shall not include the following3 7,a7 ,software that is intended for administrative and operational support of a health care facility or the processing and maintenance of financial records1 appointment schedules1 business analytics1 communication1 information about patient populations1 and laboratory workflow processes4 7,b7 ,software that is intended for the purpose of maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or disorder4 7,c7 ,except for software intended to interpret or analyze medical image data for the purpose of diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or condition1 electronic patient records1 to the extent that such records are intended to transfer1 store1 convert formats1 or display the equivalent of a paper medical chart1 which may include patient history records if-- 7i7 such records were created1 stored1 transferred1 or reviewed by health care professionals1 or by individuals working under supervision of such professionals2 and 7ii7 such records are part of health information technology that is certified under section #cjja7;c77#e7 of the ,public ,health ,service ,act as being in compliance with applicable certification criteria adopted under subtitle ,a of title ,,xxx of such ,act4 7,d7 ,except for software intended to interpret or analyze clinical laboratory test data1 software that is intended to transfer1 store1 convert formats1 or display-- 7i7 clinical laboratory test report data1 results1 or findings prior to analysis or interpretation by a health care professional2 or 7ii7 clinical laboratory test report data1 results1 or findings1 or related patient education information with respect to such data1 to a patient4 7,e7 ,except for a device accessory and software that is intended to acquire1 process1 or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system1 software that-- 7i7 is intended to display1 analyze1 or print medical information about a patient or other medical information 7such as peer-reviewed clinical studies and clinical practice guidelines72 7ii7 is intended to support or provide recommendations to a health care professional about prevention1 diagnosis1 or treatment2 and 7iii7 enables the health care professional to independently review the basis for each recommendation that the software presents such that it is not the intent that the health care professional rely solely on any specific recommendations or results provided by such software to make a clinical diagnosis or treatment decision4 7#b7 ,multiple functionality products ,in the case of a product with multiple functionality that contains a software function that is excluded under paragraph 7#a7 from the definition of a device under section #bja7;h7 and a function that meets the definition of device under section #bja7;h71 the ,secretary shall not regulate the excluded software function of the product as a device1 but the ,secretary may assess such software function for the purpose of determining the safety and effectiveness of the device function of the product4 7#c7 ,rules of construction ,nothing in this subsection shall be construed as limiting the authority of the ,secretary to-- 7,a7 exercise enforcement discretion as to any device subject to regulation under this ,act2 or 7,b7 regulate software devices used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans4 4 #c4 ,quality and standards ,the ,secretary of ,health and ,human ,services shall ensure that software described in subparagraphs 7,c71 7,d71 and 7,e7 of subsection 7o77#a7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 7as amended by section #c7 is consistent with appropriate quality principles and standards for software development and validation4 #d4 ,classification of accessories ,subsection #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended by adding at the end the following3 7#i7 ,the ,secretary shall classify an accessory under this section based on the intended use of the accessory1 notwithstanding the classification of any other device with which such accessory is intended to be used4 4 #e4 ,conforming amendment ,section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 is amended by adding at the end ,the term device does not include medical and decision support software described in section #ebj7o744 #a4 ,short title ,this ,act may be cited as the ,medical ,electronic ,data ,technology ,enhancement for ,consumers' ,health ,act or the ,,medtech ,act4 #b4 ,regulation of medical software 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7o7 ,regulation of medical and certain decisions support software 7#a7 ,regulation of certain software ,the term device1 as defined in section #bja7;h71 shall not include a software function that is intended-- 7,a7 for administrative support of a health care facility1 including the processing and maintenance of financial records1 claims or billing information1 appointment schedules1 business analytics1 information about patient populations1 admissions1 practice and inventory management1 analysis of historical claims data to predict future utilization or cost-effectiveness1 determination of health benefit eligibility1 population health management1 and laboratory workflow2 7,b7 for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or condition2 7,c7 to serve as electronic patient records1 including patient-provided information1 to the extent that such records are intended to transfer1 store1 convert formats1 or display the equivalent of a paper medical chart1 so long as-- 7i7 such records were created1 stored1 transferred1 or reviewed by health care professionals1 or by individuals working under supervision of such professionals2 7ii7 such records are part of health information technology that is certified under section #cjja7;c77#e7 of the ,public ,health ,service ,act as being in compliance with applicable certification criteria adopted under subtitle ,a of title ,,xxx of such ,act2 and 7iii7 such function is not intended to interpret or analyze patient records1 including medical image data1 for the purpose of the diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or condition2 7,d7 for transferring1 storing1 converting formats1 or displaying clinical laboratory test or other device data and results1 findings by a health care professional with respect to such data and results1 general information about such findings1 and general background information about such laboratory test or other device1 unless such function is intended to interpret or analyze clinical laboratory test or other device data1 results1 and findings2 or 7,e7 for the purpose of-- 7i7 displaying1 analyzing1 or printing medical information about a patient or other medical information 7such as peer-reviewed clinical studies and clinical practice guidelines72 7ii7 supporting or providing recommendations to a health care professional about prevention1 diagnosis1 or treatment of a disease or condition2 and 7iii7 enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient2 unless a function described in subparagraph 7,e7 is intended to acquire1 process1 or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system4 7#b7 ,multiple functionality products ,in the case of a product with multiple functions that contains-- 7,a7 at least one software function that meets the criteria under paragraph 7#a7 or that otherwise does not meet the definition of device under section #bja7;h72 and 7,b7 at least one function that does not meet the criteria under paragraph 7#a7 and that otherwise meets the definition of a device under section #bja7;h71 the ,secretary shall not regulate the software function of such product described in subparagraph 7,a7 as a device4 ,notwithstanding the preceding sentence1 when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph 7,b71 the ,secretary may assess the impact that the software function or functions described in subparagraph 7,a7 have on such device function or functions4 7#c7 ,exception 7,a7 ,in general ,notwithstanding paragraph 7#a71 a software function shall not be excluded from the definition of device under section #bja7;h7 if-- 7i7 the ,secretary determines that the software function meets the criteria under subparagraph 7,c71 7,d71 or 7,e7 of paragraph 7#a72 7ii7 the ,secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences2 and 7iii7 the software function has been identified in a final order issued by the ,secretary under subparagraph 7,b74 7,b7 ,procedures ,subparagraph 7,a7 shall apply only if the ,secretary-- 7i7 publishes a notification and proposed order in the ,federal ,register2 7ii7 includes in such notification the ,secretary's finding1 including the rationale and identification of the evidence on which such finding was based1 as described in subparagraph 7,a77ii72 and 7iii7 provides for a period of not less than #cj calendar days for public comments before issuing a final order or withdrawing such proposed order4 7,c7 ,considerations ,in making a finding under subparagraph 7,a77ii7 with respect to a software function1 the ,secretary shall consider the following3 7i7 ,the likelihood and severity of patient harm if the software function were to not perform as intended4 7ii7 ,the extent to which the software function is intended to support the clinical judgment of a health care professional4 7iii7 ,whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function4 7iv7 ,the intended user and user environment1 such as whether a health care professional will use a software function of a type described in subparagraph 7,e7 of paragraph 7#a74 7#d7 ,rules of construction ,nothing in this subsection shall be construed as limiting the authority of the ,secretary to-- 7,a7 exercise enforcement discretion as to any device subject to regulation under this ,act2 7,b7 regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans2 or 7,c7 regulate software as a device under this ,act if such software meets the criteria in section #eac7;a77#a77;,c74 4 7b7 ,report ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary71 after consultation with agencies and offices of the ,department of ,health and ,human ,services involved in health information technology1 shall publish a report1 every #b years beginning after the date of enactment of this ,act1 that-- 7#a7 includes input from outside experts1 such as representatives of patients1 consumers1 health care providers1 startup companies1 health plans or other third-party payers1 venture capital investors1 information technology vendors1 health information technology vendors1 small businesses1 purchasers1 employers1 and other stakeholders with relevant expertise1 as determined by the ,secretary2 7#b7 examines information available to the ,secretary on any risks and benefits to health associated with software functions described in section #ebj7o77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 7as amended by subsection 7a7 of this ,act72 and 7#c7 summarizes findings regarding the impact of such software functions on patient safety1 including best practices to promote safety1 education1 and competency related to such functions4 7c7 ,classification of accessories ,subsection #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended by adding at the end the following3 7#i7 ,the ,secretary shall classify an accessory under this section based on the intended use of the accessory1 notwithstanding the classification of any other device with which such accessory is intended to be used4 4 7d7 ,conforming amendment ,section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 is amended by adding at the end the following3 ,the term device does not include software functions excluded pursuant to section #ebj7o744 ,amend the title so as to read3 ,a bill to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for the regulation of patient records and certain decision support software44 ,april #d1 #bjaf,reported with an amendment and an amendment to the title