,,ii #aaeth ,,congress #ast ,session ,s4 #ajfi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #h1 #bjag,mr4 ,casey 7for himself1 ,ms4 ,warren1 and ,mr4 ,franken7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish pilot projects in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices4 #a4 ,short title ,this ,act may be cited as the ,medical ,device ,safety ,monitoring ,act4 #b4 ,device pilot projects 7a7 ,postmarket pilot ,section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 is amended by adding at the end the following3 7i7 ,pilot projects 7#a7 ,in general ,in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices1 including responses to adverse events and malfunctions1 and to advance the objectives of part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 and advance the objectives of1 and evaluate innovative new methods of compliance with1 this section and section #ebb1 the ,secretary shall1 within one year of the date of enactment of this subsection1 initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of device or device type1 or continue existing projects in accordance with paragraph 7#c71 that meet all of the following requirements3 7,a7 ,are designed to efficiently generate reliable and timely safety and active surveillance data for use by the ,secretary or manufacturers of the devices that are involved in the pilot project4 7,b7 ,inform the development of methods1 systems1 data criteria1 and programs that could be used to support safety and active surveillance activities for devices not included in such project4 7,c7 ,are designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders1 including consumer groups and device manufacturers4 7,d7 ,use electronic health data including claims data1 patient survey data1 and any other data1 as the ,secretary determines appropriate4 7,e7 ,prioritize devices and device types that meet one or more of the following criteria3 7i7 ,devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health4 7ii7 ,devices and device types that are widely used4 7iii7 ,devices and device types1 the failure of which has significant health consequences4 7iv7 ,devices and device types for which the ,secretary has received public recommendations in accordance with paragraph 7#b77;,b7 and has determined to meet one of the criteria under clauses 7i7 through 7iii7 and is appropriate for a project under this subsection4 7#b7 ,participation ,the ,secretary shall establish the conditions and processes for-- 7,a7 authorizing voluntary participation of a manufacturer of a device in the pilot project described in paragraph 7#a72 and 7,b7 facilitating public recommendations for devices to be prioritized under the pilot project described in paragraph 7#a71 including requirements for the data necessary to support such recommendation4 7#c7 ,implementation ,the ,secretary may satisfy the requirements of paragraphs 7#a7 and 7#b7 by continuing or expanding existing projects1 or by beginning new projects1 that meet the criteria of subparagraphs 7,a7 through 7,e7 of paragraph 7#a7 or by entering into contracts1 cooperative agreements1 grants1 or other appropriate agreements with public or private entities that have a significant presence in the ,united ,states1 and meet the following additional conditions3 7,a7 ,if such public or private entities are a component of another organization1 the entities have established appropriate security measures to maintain the confidentiality and privacy of the data described in paragraph 7#a77;,d7 and the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirements4 7,b7 ,in the case of the termination or nonrenewal of such contracts1 cooperative agreements1 grants1 or other appropriate agreements1 the entities shall comply with each of the following3 7i7 ,continue to comply with the confidentiality and privacy requirements under this subsection with respect to all data disclosed to the entity4 7ii7 ,return any data disclosed to such entity under this subsection to which it would not otherwise have access or1 if returning the data is not practicable1 destroy the data4 7,c7 ,have at least one of the following qualifications3 7i7 ,research1 statistical1 epidemiologic1 or clinical capability and expertise to conduct and complete the activities under this subsection1 including the capability and expertise to provide the ,secretary access to de-identified data consistent with the requirements of this subsection4 7ii7 ,an information technology infrastructure in place to support electronic data and operational standards to provide security for such data1 as appropriate4 7iii7 ,experience with1 and expertise on1 the development of device safety and effectiveness research and surveillance using electronic health data4 7iv7 ,other expertise which the ,secretary determines necessary to fulfill the activities under this subsection4 7#d7 ,review of contract in the event of a merger or acquisition ,the ,secretary shall review a contract with a qualified entity under this subsection in the event of a merger or acquisition of the entity in order to ensure that the requirements under this subsection will continue to be met4 7#e7 ,report to ,congress ,not later than #ah months after the date of enactment of this subsection1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing a description of the pilot projects being conducted pursuant to this subsection1 including for each pilot project-- 7,a7 how the project is being implemented in accordance with paragraph 7#c7 and the contractor or grantee as applicable2 7,b7 the number of manufacturers that have agreed to participate2 7,c7 the data sources used2 7,d7 the devices or device categories involved2 and 7,e7 the number of patients involved4 7#f7 ,compliance with requirements for records or reports on devices ,the participation of a manufacturer in a pilot project under this subsection shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program implemented under this ,act4 ,the ,secretary may determine that1 for the specified time period to be determined by the ,secretary1 a manufacturer's participation in a pilot project under this subsection may meet certain other requirements of this section or section #ebb if-- 7,a7 the project has demonstrated success in capturing relevant adverse event information2 and 7,b7 the ,secretary has established procedures for making adverse event and safety information collected from the pilot public1 to the extent possible1 if collected pursuant to this section or section #ebb4 7#g7 ,privacy requirements ,with respect to the pilot projects conducted pursuant to this subsection-- 7,a7 individual identifiable health information shall not be disclosed when presenting any information from such project2 and 7,b7 such projects shall comply with section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 and sections #eeb and #eeb;a of title #e1 ,united ,states ,code4 7#h7 ,other compliance ,any pilot program undertaken in coordination with the comprehensive system described in paragraph 7#a77;,c71 including pilot projects under this subsection1 that relates to the use of real world evidence for devices shall comply with paragraph 7#a77;,b71 the conditions listed in subparagraphs 7,a7 and 7,b7 of paragraph 7#c71 and paragraphs 7#d71 7#e71 7#f71 and 7#g74 7#i7 ,sunset ,this subsection shall cease to have force or effect on ,october #a1 #bjbb4 4 7b7 ,report ,not later than ,january #ca1 #bjba1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall conduct a review through an independent third party to evaluate the strengths1 limitations1 and appropriate use of evidence collected pursuant to real world evidence pilot projects described in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag and subsection 7i7 of section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i71 as amended by subsection 7a71 for informing premarket and postmarket decisionmaking for multiple device types1 and to determine whether the methods1 systems1 and programs in such pilot projects efficiently generate reliable and timely evidence about the effectiveness or safety surveillance of devices4