,,ii #aacth ,,congress #ast ,session ,s4 #afhe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #ab1 #bjac,mr4 ,portman introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend the ,public ,health ,service ,act and the ,social ,security ,act to extend health information technology assistance eligibility to behavioral health1 mental health1 and substance abuse professionals and facilities1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,behavioral ,health ,information ,technology ,coordination ,act of #bjac4 #b4 ,extension of health information technology assistance for behavioral and mental health and substance abuse ,section #cjjj7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7#c77 is amended by inserting before and any other category the following3 behavioral and mental health professionals 7as defined in section #cca7;a77#c77;,e77i771 a substance abuse professional1 a psychiatric hospital 7as defined in section #ahfa7;f7 of the ,social ,security ,act71 a community mental health center meeting the criteria specified in section #aiac7;c71 a residential or outpatient mental health or substance abuse treatment facility14 #c4 ,extension of eligibility for medicare and ,medicaid health information technology implementation assistance 7a7 ,payment incentives for eligible professionals under medicare ,section #ahdh of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 is amended-- 7#a7 in subsection 7a77#g7-- 7,a7 in subparagraph 7,e71 by adding at the end the following new clause3 7iv7 ,additional eligible professional ,the term additional eligible professional means a clinical psychologist providing qualified psychologist services 7as defined in section #ahfa7;ii774 2 and 7,b7 by adding at the end the following new subparagraph3 7,f7 ,application to additional eligible professionals ,the ,secretary shall apply the provisions of this paragraph with respect to an additional eligible professional in the same manner as such provisions apply to an eligible professional1 except in applying subparagraph 7,a7-- 7i7 in clause 7i71 the reference to #bjae shall be deemed a reference to #bjai2 7ii7 in clause 7ii71 the references to #bjae1 #bjaf1 and #bjag shall be deemed references to #bjai1 #bjbj1 and #bjba1 respectively2 and 7iii7 in clause 7iii71 the reference to #bjah shall be deemed a reference to #bjbb4 2 and 7#b7 in subsection 7o7-- 7,a7 in paragraph 7#e71 by adding at the end the following new subparagraph3 7,d7 ,additional eligible professional ,the term additional eligible professional means a clinical psychologist providing qualified psychologist services 7as defined in section #ahfa7;ii774 2 and 7,b7 by adding at the end the following new paragraph3 7#f7 ,application to additional eligible professionals ,the ,secretary shall apply the provisions of this subsection with respect to an additional eligible professional in the same manner as such provisions apply to an eligible professional1 except in applying-- 7,a7 paragraph 7#a77;,a77ii71 the reference to #bjaf shall be deemed a reference to #bjbj2 7,b7 paragraph 7#a77;,b77ii71 the references to #bjaa and #bjab shall be deemed references to #bjae and #bjaf1 respectively2 7,c7 paragraph 7#a77;,b77iii71 the references to #bjac shall be deemed references to #bjag2 7,d7 paragraph 7#a77;,b77v71 the references to #bjad shall be deemed references to #bjah2 and 7,e7 paragraph 7#a77;,e71 the reference to #bjaa shall be deemed a reference to #bjae4 4 7b7 ,eligible hospitals ,section #ahhf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 is amended-- 7#a7 in subsection 7b77#c77;,b77ix71 by adding at the end the following new subclause3 7,v7 ,the ,secretary shall apply the provisions of this subsection with respect to an additional eligible hospital 7as defined in subsection 7n77#f77;,c77 in the same manner as such provisions apply to an eligible hospital1 except in applying-- 7aa7 subclause 7,i71 the references to #bjae1 #bjaf1 and #bjag shall be deemed references to #bjai1 #bjbj1 and #bjba1 respectively2 and 7bb7 subclause 7,,iii71 the reference to #bjae shall be deemed a reference to #bjai4 2 and 7#b7 in subsection 7n7-- 7,a7 in paragraph 7#f71 by adding at the end the following new subparagraph3 7,c7 ,additional eligible hospital ,the term additional eligible hospital means an inpatient hospital that is a psychiatric hospital 7as defined in section #ahfa7;f774 2 and 7,b7 by adding at the end the following new paragraph3 7#g7 ,application to additional eligible hospitals ,the ,secretary shall apply the provisions of this subsection with respect to an additional eligible hospital in the same manner as such provisions apply to an eligible hospital1 except in applying-- 7,a7 paragraph 7#b77;,e77ii71 the references to #bjac and #bjae shall be deemed references to #bjag and #bjai1 respectively2 and 7,b7 paragraph 7#b77;,g77i71 the reference to #bjaa shall be deemed a reference to #bjae4 4 7c7 ,medicaid providers ,section #aijc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7t77 is amended-- 7#a7 in paragraph 7#b77;,b7-- 7,a7 in clause 7i71 by striking 1 or and inserting a semicolon2 7,b7 in clause 7ii71 by striking the period and inserting a semicolon2 and 7,c7 by adding after clause 7ii7 the following new clauses3 7iii7 a public hospital that is principally a psychiatric hospital 7as defined in section #ahfa7;f772 7iv7 a private hospital that is principally a psychiatric hospital 7as defined in section #ahfa7;f77 and that has at least #aj percent of its patient volume 7as estimated in accordance with a methodology established by the ,secretary7 attributable to individuals receiving medical assistance under this title2 7v7 a community mental health center meeting the criteria specified in section #aiac7;c7 of the ,public ,health ,service ,act2 or 7vi7 a residential or outpatient mental health or substance abuse treatment facility that-- 7,i7 is accredited by the ,joint ,commission on ,accreditation of ,healthcare ,organizations1 the ,commission on ,accreditation of ,rehabilitation ,facilities1 the ,council on ,accreditation1 or any other national accrediting agency recognized by the ,secretary2 and 7,,ii7 has at least #aj percent of its patient volume 7as estimated in accordance with a methodology established by the ,secretary7 attributable to individuals receiving medical assistance under this title4 2 and 7#b7 in paragraph 7#c77;,b7-- 7,a7 in clause 7iv71 by striking and after the semicolon2 7,b7 in clause 7v71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following new clause3 7vi7 clinical psychologist providing qualified psychologist services 7as defined in section #ahfa7;ii771 if such clinical psychologist is practicing in an outpatient clinic that-- 7,i7 is led by a clinical psychologist2 and 7,,ii7 is not otherwise receiving payment under paragraph 7#a7 as a ,medicaid provider described in paragraph 7#b77;,b74 4 7d7 ,medicare ,advantage organizations ,section #ahec of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7 is amended-- 7#a7 in subsection 7l7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting or additional eligible professionals 7as described in paragraph 7#i77 after paragraph 7#b72 and 7ii7 by inserting and additional eligible professionals before under such sections2 7,b7 in paragraph 7#c77;,b7-- 7i7 in clause 7i7 in the matter preceding subclause 7,i71 by inserting or an additional eligible professional described in paragraph 7#i7 after paragraph 7#b72 and 7ii7 in clause 7ii7-- 7,i7 in the matter preceding subclause 7,i71 by inserting or an additional eligible professional described in paragraph 7#i7 after paragraph 7#b72 and 7,,ii7 in subclause 7,i71 by inserting or an additional eligible professional1 respectively1 after eligible professional2 7,c7 in paragraph 7#c77;,c71 by inserting and additional eligible professionals after all eligible professionals2 7,d7 in paragraph 7#d77;,d71 by adding at the end the following new sentence3 ,in the case that a qualifying ,,ma organization attests that not all additional eligible professionals of the organization are meaningful ,,ehr users with respect to an applicable year1 the ,secretary shall apply the payment adjustment under this paragraph based on the proportion of all such additional eligible professionals of the organization that are not meaningful ,,ehr users for such year42 7,e7 in paragraph 7#f77;,a71 by inserting and1 as applicable1 each additional eligible professional described in paragraph 7#i7 after paragraph 7#b72 7,f7 in paragraph 7#f77;,b71 by inserting and1 as applicable1 each additional eligible hospital described in paragraph 7#i7 after subsection 7m77#a72 7,g7 in paragraph 7#g77;,a71 by inserting and1 as applicable1 additional eligible professionals after eligible professionals2 7,h7 in paragraph 7#g77;,b71 by inserting and1 as applicable1 additional eligible professionals after eligible professionals2 7,i7 in paragraph 7#h77;,b71 by inserting and additional eligible professionals described in paragraph 7#i7 after paragraph 7#b72 and 7,j7 by adding at the end the following new paragraph3 7#i7 ,additional eligible professional described ,with respect to a qualifying ,,ma organization1 an additional eligible professional described in this paragraph is an additional eligible professional 7as defined for purposes of section #ahdh7o77 who-- 7,a7 7i7 is employed by the organization2 or 7ii7 7,i7 is employed by1 or is a partner of1 an entity that through contract with the organization furnishes at least #hj percent of the entity's ,medicare patient care services to enrollees of such organization2 and 7,,ii7 furnishes at least #hj percent of the professional services of the additional eligible professional covered under this title to enrollees of the organization2 and 7,b7 furnishes1 on average1 at least #bj hours per week of patient care services4 2 and 7#b7 in subsection 7m7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting or additional eligible hospitals 7as described in paragraph 7#g77 after paragraph 7#b72 and 7ii7 by inserting and additional eligible hospitals before under such sections2 7,b7 in paragraph 7#c77;,a77i71 by inserting or additional eligible hospital after eligible hospital2 7,c7 in paragraph 7#c77;,a77ii71 by inserting or an additional eligible hospital after eligible hospital in each place it occurs2 7,d7 in paragraph 7#c77;,b7-- 7i7 in clause 7i71 by inserting or an additional eligible hospital described in paragraph 7#g7 after paragraph 7#b72 and 7ii7 in clause 7ii7-- 7,i7 in the matter preceding subclause 7,i71 by inserting or an additional eligible hospital described in paragraph 7#g7 after paragraph 7#b72 and 7,,ii7 in subclause 7,i71 by inserting or an additional eligible hospital1 respectively1 after eligible hospital2 7,e7 in paragraph 7#d77;,a71 by inserting or one or more additional eligible hospitals 7as defined in section #ahhf7n771 as appropriate1 after section #ahhf7n77#f77;,a772 7,f7 in paragraph 7#d77;,d71 by adding at the end the following new sentence3 ,in the case that a qualifying ,,ma organization attests that not all additional eligible hospitals of the organization are meaningful ,,ehr users with respect to an applicable period1 the ,secretary shall apply the payment adjustment under this paragraph based on the methodology specified by the ,secretary1 taking into account the proportion of such additional eligible hospitals1 or discharges from such hospitals1 that are not meaningful ,,ehr users for such period42 7,g7 in paragraph 7#e77;,a71 by inserting and1 as applicable1 each additional eligible hospital described in paragraph 7#g7 after paragraph 7#b72 7,h7 in paragraph 7#e77;,b71 by inserting and additional eligible hospitals1 as applicable1 after eligible hospitals2 7,i7 in paragraph 7#f77;,b71 by inserting and additional eligible hospitals described in paragraph 7#g7 after paragraph 7#b72 and 7,j7 by adding at the end the following new paragraph3 7#g7 ,additional eligible hospital described ,with respect to a qualifying ,,ma organization1 an additional eligible hospital described in this paragraph is an additional eligible hospital 7as defined in section #ahhf7n77#f77;,c77 that is under common corporate governance with such organization and serves individuals enrolled under an ,,ma plan offered by such organization4 4 #d4 ,providing protections for certain providers1 vendors1 and users of certified ,,ehr technology 7a7 ,covered entities 7#a7 ,covered entities ,for purposes of this section1 a covered entity means1 with respect to certified ,,ehr technology 7as defined in section #ahdh7o77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#d777 and a year1 any of the following3 7,a7 ,meaningful ,,ehr users 7i7 ,an eligible professional 7as defined in paragraph 7#e77;,c7 of section #ahdh7o7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o777 determined to be a meaningful ,,ehr user under paragraph 7#b7 of such section for the ,,ehr reporting period 7as defined in paragraph 7#e77;,b7 of such section7 during such year1 or an additional eligible professional 7as defined in paragraph 7#e77;,d7 of such section7 determined to be a meaningful ,,ehr user pursuant to paragraph 7#f7 of such section for the ,,ehr reporting period 7as defined in paragraph 7#e77;,b7 of such section7 during such year4 7ii7 ,in the case of a qualifying ,,ma organization 7as defined in paragraph 7#e7 of section #ahec7l7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7l7771 an eligible professional described in paragraph 7#b7 of such section or1 as applicable1 an additional eligible professional described in paragraph 7#i7 of such section of the organization who the organization attests under paragraph 7#f7 of such section to be a meaningful ,,ehr user for such year4 7iii7 ,in the case of a qualifying ,,ma organization 7as so defined71 an eligible hospital described in section #ahec7m77#b7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7m77#b77 or1 as applicable1 an additional eligible hospital described in section #ahec7m77#g7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7m77#g77 of the organization which attests under section #ahec7l77#f7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7l77#f77 to be a meaningful ,,ehr user for the applicable period with respect to such year4 7iv7 ,an eligible hospital 7as defined in paragraph 7#f77;,b7 of section #ahhf7n7 of such ,act 7#db ,u4,s4,c4 #acieww7n77 determined to be a meaningful ,,ehr user under paragraph 7#c7 of such section for the ,,ehr reporting period 7as defined in paragraph 7#f77;,a7 of such section7 with respect to such year1 or an additional eligible hospital 7as defined in paragraph 7#f77;,c7 of such section7 determined to be a meaningful ,,ehr user under paragraph 7#g7 of such section for the ,,ehr reporting period 7as defined in paragraph 7#f77;,a7 of such section7 with respect to such year4 7v7 ,a critical access hospital determined pursuant to section #ahad7l77#c7 of such ,act 7#db ,u4,s4,c4 #acie;f7l77#c77 to be a meaningful ,,ehr user 7as would be determined under paragraph 7#c7 of section #ahhf7n7 of such ,act 7#db ,u4,s4,c4 #acieww7n777 for an ,,ehr reporting period 7as defined in paragraph 7#f77;,a7 of such section7 for a cost reporting period beginning during such year4 7vi7 ,a ,medicaid provider 7as defined in paragraph 7#b7 of section #aijc7t7 of such ,act 7#db ,u4,s4,c4 #acif;b7t777 eligible for payments described in paragraph 7#a7 of such section for such year4 7,b7 ,health information exchange entities ,individuals and entities 7other than ,states or ,state designated entities7 which during such year are health information exchange contractors 7consisting of technology providers71 health information exchange participants 7consisting of organizations providing supportive technology to a health information exchange71 and other users of health information exchanges 7consisting of other entities that may be exchanging clinical or administrative data74 ,manufacturers of electronic health record 7,,ehr7 software and other health information technologies who participate in the reporting of adverse events or who otherwise contribute relevant patient safety work product under subsection 7b77#a74 7,c7 ,certain other ,,ehr users ,a health care professional who1 during such year-- 7i7 is a user of such certified ,,ehr technology2 7ii7 is not eligible for incentive payments based on meaningful use of such technology under title ,,xviii or ,,xix of the ,social ,security ,act solely because the professional is not-- 7,i7 an eligible professional 7as defined in paragraph 7#e77;,c7 of section #ahdh7o7 of such ,act 7#db ,u4,s4,c4 #aciew-#d7o7772 7,,ii7 an eligible professional described in paragraph 7#b7 of section #ahec7l7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7l77 or1 as applicable1 an additional eligible professional described in paragraph 7#i7 of such section1 with respect to a qualifying ,,ma organization 7as defined in paragraph 7#e7 of such section72 7,,iii7 an eligible hospital described in paragraph 7#b7 of section #ahec7m7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7m77 or1 as applicable1 an additional eligible hospital described in paragraph 7#g7 of such section1 with respect to such a qualifying ,,ma organization2 7,,iv7 an eligible hospital 7as defined in paragraph 7#f77;,b7 of section #ahhf7n7 of such ,act 7#db ,u4,s4,c4 #acieww7n7772 7,v7 a critical access hospital2 7,,vi7 a ,medicaid provider 7as defined in paragraph 7#b7 of section #aijc7t7 of such ,act 7#db ,u4,s4,c4 #acif;b7t7772 7,,vii7 an additional eligible professional 7as defined in paragraph 7#e77;,d7 of section #ahdh7o7 of such ,act 7#db ,u4,s4,c4 #aciew-#d7o7772 or 7,,viii7 an additional eligible hospital 7as defined in paragraph 7#f77;,c7 of section #ahhf7n7 of such ,act 7#db ,u4,s4,c4 #acieww7n7772 and 7iii7 attests1 to the satisfaction of the ,secretary of ,health and ,human ,services1 that but for the reason described in clause 7ii71 the professional would otherwise satisfy criteria to be eligible for such incentive payments during such year4 7b7 ,improving patient safety through error reporting and remediation1 and clarification of authority 7#a7 ,quarterly reporting by patient safety organizations ,paragraph 7#a7 of section #ibd7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#bd7 is amended by adding at the end the following3 7,h7 ,not less than quarterly each year1 the entity shall submit to the ,office of the ,national ,coordinator findings that-- 7i7 exclude any individually identifiable information2 7ii7 are based on information submitted to the entity by covered entities 7as defined in section #d7;a77#a7 of the ,behavioral ,health ,information ,technology ,coordination ,act of #bjac72 7iii7 describe the number and nature of ,,ehr-related adverse events with respect to certified ,,ehr technology 7as such terms are defined in section #d7;e7 of such ,act7 so reported2 and 7iv7 for each such ,,ehr-related adverse event1 identify the type event and the type electronic health record involved4 4 7#b7 ,application of safety organization privilege and confidentiality protections ,in the case of a covered entity that submits to a patient safety organization information on an ,,ehr-related adverse event with respect to certified ,,ehr technology1 and in the case of the collection and maintenance of such information by a patient safety organization1 the provisions of section #ibb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#bb7 shall apply to such information and to the organization and the entity in the same manner such provisions apply to patient safety work product and a patient safety organization and provider under part ,c of title ,,ix of such ,act 7#db ,u4,s4,c4 #bii;b-#b et seq474 7#c7 ,clarification of authority ,certified ,,ehr technology shall not be considered to be a device for purposes of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7c7 ,rules relating to ,e-,discovery ,in any health care lawsuit against a covered entity that is related to an ,,ehr-related adverse event1 with respect to certified ,,ehr technology used or provided by the covered entity1 electronic discovery shall be limited to-- 7#a7 information that is related to such ,,ehr-related adverse event2 and 7#b7 information from the period in which such ,,ehr-related adverse event occurred4 7d7 ,legal protections for covered entities 7#a7 ,general ,for a covered entity described in subsection 7a71 the following protections apply3 7,a7 ,encouraging speedy resolution of claims 7i7 ,general ,a claimant may not commence a health care lawsuit against a covered entity on any date that is #c years after the date of manifestation of injury or #a year after the claimant discovers1 or through the use of reasonable diligence should have discovered1 the injury1 whichever occurs first4 ,this limitation shall be tolled to the extent that the claimant is able to prove-- 7,i7 fraud2 7,,ii7 intentional concealment2 or 7,,iii7 the presence of a foreign body1 which has no therapeutic or diagnostic purpose or effect1 in the person of the injured person4 7ii7 ,treatment of a minor ,a health care lawsuit by or on behalf of a claimant under the age of #ag years at the time the injury was suffered may not be commenced after the date that is #c years after the date of the alleged manifestation of injury except that actions by a claimant under the age of #f years may not be commenced after the date that is #c years after the date of manifestation of injury or prior to the claimant's #hth birthday1 whichever provides a longer period4 ,this limitation shall be tolled for claimants under the age of #ag years for any period during which a parent or guardian and a health care provider or health care organization have committed fraud or collusion in the failure to bring an action on behalf of the claimant4 7,b7 ,equitable assignment of responsibility ,in any health care lawsuit against a covered entity-- 7i7 each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury1 as determined under clause 7iii72 7ii7 whenever a judgment of liability is rendered as to any such party1 a separate judgment shall be rendered against each such party for the amount allocated to such party2 and 7iii7 for purposes of this subparagraph1 the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm4 7,c7 ,subsequent remedial measures ,evidence of subsequent remedial measures to an ,,ehr-related adverse event with respect to certified ,,ehr technology used or provided by the covered entity 7including changes to the certified ,,ehr system1 additional training requirements1 or changes to standard operating procedures7 by a covered entity shall not be admissible in health care lawsuits4 7,d7 ,increased burden of proof protection for covered entities ,punitive damages may1 if otherwise permitted by applicable ,state or ,federal law1 be awarded against any covered entity in a health care lawsuit only if it is proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant4 ,in any such health care lawsuit where no judgment for compensatory damages is rendered against such entity1 no punitive damages may be awarded with respect to the claim in such lawsuit4 7,e7 ,protection from libel or slander ,covered entities and employees1 agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified ,,ehr technology and for the transfer of such information to another eligible provider1 hospital or health information exchange1 if the information1 transfer of information1 or entries were made in good faith and without malice4 7e7 ,definitions ,in this section3 7#a7 ,claimant ,the term claimant means any person who brings a health care lawsuit1 including a person who asserts or claims a right to legal or equitable contribution1 indemnity1 or subrogation1 arising out of a health care liability claim or action1 and any person on whose behalf such a claim is asserted or such an action is brought1 whether deceased1 incompetent1 or a minor4 7#b7 ,compensatory damages ,the term compensatory damages means objectively verifiable monetary losses incurred as a result of the provisions of1 use of1 or payment for 7or failure to provide1 use1 or pay for7 health care services or medical products1 such as past and future medical expenses1 loss of past and future earnings1 cost of obtaining domestic services1 loss of employment1 and loss of business or employment opportunities1 damages for physical and emotional pain1 suffering1 inconvenience1 physical impairment1 mental anguish1 disfigurement1 loss of enjoyment in life1 loss of society and companionship1 loss of consortium 7other than loss of domestic service71 hedonic damages1 injury to reputation1 and all other nonpecuniary losses of any kind or nature4 ,such term includes economic damages and noneconomic damages1 as such terms are defined in this subsection4 7#c7 ,economic damages ,the term economic damages means objectively verifiable monetary losses incurred as a result of the provisions of1 use of1 or payment for 7or failure to provide1 use1 or pay for7 health care services or medical products1 such as past and future medical expenses1 loss of past and future earnings1 cost of obtaining domestic services1 loss of employment1 and loss of business or employment opportunities4 7#d7 ,certified ,,ehr technology ,the term certified ,,ehr technology has the meaning given such term in section #ahdh7o77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#d774 7#e7 ,,ehr-related adverse event ,the term ,,ehr-related adverse event means1 with respect to a provider1 a defect1 malfunction1 or error in the certified health information technology or electronic health record used by the provider1 or in the input or output of data maintained through such technology or record1 that results or could reasonably result in harm to a patient4 7#f7 ,health care lawsuit ,the term health care lawsuit means any health care liability claim concerning the provision of health care items or services or any medical product affecting interstate commerce1 or any health care liability action concerning the provision of health care items or services or any medical product affecting interstate commerce1 brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider1 a health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 regardless of the theory of liability on which the claim is based1 or the number of claimants1 plaintiffs1 defendants1 or other parties1 or the number of claims or causes of action1 in which the claimant alleges a health care liability claim4 ,such term does not include a claim or action which is based on criminal liability2 which seeks civil fines or penalties paid to ,federal1 ,state1 or local government2 or which is grounded in antitrust4 7#g7 ,health care liability action ,the term health care liability action means a civil action brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider1 a health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action1 in which the claimant alleges a health care liability claim4 7#h7 ,health care liability claim ,the term health care liability claim means a demand by any person1 whether or not pursuant to alternative dispute resolution1 against a health care provider1 health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 including third-party claims1 cross-claims1 counter-claims1 or contribution claims1 which are based upon the provision of1 use of1 or payment for 7or the failure to provide1 use or pay for7 health care services or medical products1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action4 7#i7 ,health care organization ,the term health care organization means any person or entity which is obligated to provide or pay for health benefits under any health plan1 including any person or entity acting under a contract or arrangement with a health care organization to provide or administer any health benefit4 7#aj7 ,health care provider ,the term health care provider means any person or entity required by ,state or ,federal laws or regulations to be licensed1 registered1 or certified to provide health care services1 and being either so licensed1 registered1 or certified1 or exempted from such requirement by other statute or regulation4 7#aa7 ,health care items or services ,the term health care items or services means any items or services provided by a health care organization1 provider1 or by any individual working under the supervision of a health care provider1 that relates to the diagnosis1 prevention1 or treatment of any human disease or impairment1 or the assessment or care of the health of human beings4 7#ab7 ,malicious intent ,to injure ,the term malicious intent to injure means intentionally causing or attempting to cause physical injury other than providing health care items or services4 7#ac7 ,medical product ,the term medical product means a drug1 device1 or biological product intended for humans1 and the terms drug1 device1 and biological product have the meanings given such terms in sections #bja7;g77#a7 and #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7 and 7h77 and section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 respectively1 including any component or raw material used therein1 but excluding health care services4 7#ad7 ,noneconomic damages ,the term noneconomic damages means damages for physical impairment1 mental anguish1 disfigurement1 loss of enjoyment of life1 loss of society and companionship1 loss of consortium 7other than loss of domestic service71 hedonic damages1 injury to reputation1 and all other nonpecuniary losses of any kind of nature4 7#ae7 ,patient safety organization ,the term patient safety organization has the meaning given to such term in section #iba of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ba74 7#af7 ,punitive damages ,the term punitive damages means damages awarded1 for the purpose of punishment or deterrence1 and not solely for compensatory purposes1 against a health care provider1 health care organization1 or a manufacturer1 distributor1 or supplier of a medical product4 ,punitive damages are neither economic nor economic damages4 7#ag7 ,state ,the term ,state means each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 the ,northern ,mariana ,islands1 the ,trust ,territory of the ,pacific ,islands1 and any other territory or possession of the ,united ,states1 or any political subdivision thereof4