,,ii #aacth ,,congress #b;d ,session ,s4 #bjjg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #aj1 #bjad,mrs4 ,fischer 7for herself1 ,mr4 ,king1 and ,mr4 ,rubio7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for regulating clinical and health software1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,preventing ,regulatory ,overreach ,to ,enhance ,care ,technology ,act of #bjad or the ,,protect ,act of #bjad4 #b4 ,findings2 sense of ,congress 7a7 ,findings ,congress finds as follows3 7#a7 ,the mobile health and mobile application economy was created in the ,united ,states and is now being exported globally1 with the market expected to exceed #bf1jjj1jjj1jjj by #bjag4 7#b7 ,the ,united ,states mobile application economy is responsible for nearly #ejj1jjj new jobs in the ,united ,states4 7#c7 ,consumer health information technologies1 including smart phones and tablets1 have the potential to transform health care delivery through reduced systemic costs1 improved patient safety1 and better clinical outcomes4 7#d7 ,clinical and health software innovation cycles evolve and move faster than the existing regulatory approval processes4 7#e7 ,consumers and innovators need a new risk-based framework for the oversight of clinical and health software that improves on the framework of the ,food and ,drug ,administration4 7#f7 ,a working group convened jointly by the ,food and ,drug ,administration1 the ,federal ,communications ,commission1 and the ,office of the ,national ,coordinator for ,health ,information ,technology identified in a report that there are several major barriers to the effective regulation of health information technology that cannot be alleviated without changes to existing law4 7b7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 the ,president and ,congress must intervene to facilitate interagency coordination across regulators that focuses agency efforts on fostering health information technology and mobile health innovation while better protecting patient safety1 improving health care1 and creating jobs in the ,united ,states2 7#b7 the ,president and the ,congress should work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software that reduces regulatory burdens1 fosters innovation1 and1 most importantly1 improves patient safety2 7#c7 ,the ,national ,institute of ,standards and ,technology should be the ,federal agency that has oversight over technical standards used by clinical software2 and 7#d7 ,the ,national ,institute of ,standards and ,technology1 in collaboration with the ,federal ,communications ,commission1 the ,national ,patient ,safety ,foundation1 and the ,office of the ,national ,coordinator for ,health ,information ,technology1 should work on next steps1 beyond current oversight efforts1 regarding health information technology1 such as collaborating with nongovernmental entities to develop certification processes and to promote best practice standards4 #c4 ,clinical software and health software 7a7 ,definitions ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7ss7 7#a7 ,the term clinical software means clinical decision support software or other software 7including any associated hardware and process dependencies7 intended for human or animal use that-- 7,a7 captures1 analyzes1 changes1 or presents patient or population clinical data or information and may recommend courses of clinical action1 but does not directly change the structure or any function of the body of man or other animals2 and 7,b7 is intended to be marketed for use only by a health care provider in a health care setting4 7#b7 ,the term health software means software 7including any associated hardware and process dependencies7 that is not clinical software and-- 7,a7 that captures1 analyzes1 changes1 or presents patient or population clinical data or information2 7,b7 that supports administrative or operational aspects of health care and is not used in the direct delivery of patient care2 or 7,c7 whose primary purpose is to act as a platform for a secondary software1 to run or act as a mechanism for connectivity1 or to store data4 7#c7 ,the terms clinical software and health software do not include software-- 7,a7 that is intended to interpret patient-specific device data and directly diagnose a patient or user without the intervention of a health care provider2 7,b7 that conducts analysis of radiological or imaging data in order to provide patient-specific diagnostic and treatment advice to a health care provider2 7,c7 whose primary purpose is integral to the function of a drug or device2 or 7,d7 that is a component of a device4 4 7b7 ,prohibition ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,clinical software and health software ,clinical software and health software shall not be subject to regulation under this ,act4 4 #d4 ,exclusion from definition of device ,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 clinical software or health software44