H.F. _____ Section 1. Section 10A.504, subsection 1, Code 2026, is 1 amended by adding the following new paragraph: 2 NEW PARAGRAPH . e. The board of autonomous medical practice. 3 Sec. 2. Section 147.13, Code 2026, is amended by adding the 4 following new subsection: 5 NEW SUBSECTION . 21. For artificial intelligence augmented 6 and autonomous service providers, the board of autonomous 7 medical practice. Notwithstanding section 4A.5, the board of 8 autonomous medical practice is not subject to dissolution. 9 Sec. 3. Section 147.14, subsection 1, Code 2026, is amended 10 by adding the following new paragraph: 11 NEW PARAGRAPH . t. For autonomous medical practice, one 12 member licensed to practice medicine and surgery or osteopathic 13 medicine and surgery, one member licensed to practice pharmacy, 14 one member who is a registered nurse or advanced practice 15 registered nurse, one member licensed to practice psychology, 16 one member who is a representative of a hospital association 17 or the chief executive officer of a hospital in this state, 18 one member who is a health care ethicist with an advanced 19 degree or significant professional experience in medical ethics 20 or bioethics, four at-large members who have demonstrated 21 expertise in health technology, artificial intelligence, 22 systems engineering, health care administration, patient 23 safety, or health care regulatory affairs, and one member 24 who is not a medical professional and represents the general 25 public. 26 Sec. 4. NEW SECTION . 153A.1 Definitions. 27 For purposes of this chapter unless the context otherwise 28 requires: 29 1. “Adverse event” means a patient death, serious physical 30 or psychological harm, or serious risk of harm reasonably 31 associated with a clinical AI service, including inappropriate 32 triage or failure to escalate care. 33 2. “Advisory AI” means an artificial intelligence that 34 analyzes patient-specific data to generate options, potential 35 -1- LSB 6924YC (5) 91 ss/ko 1/ 33

H.F. _____ diagnoses, risk stratification, or therapeutic suggestions to a 1 licensed health care provider or directly to a user, where such 2 output is intended to inform but not substitute for independent 3 clinical judgment, and where the provider or user is expected 4 to review, contextualize, and determine whether and how to act 5 upon the suggestion for each patient encounter. 6 3. “Artificial intelligence augmented and autonomous service 7 provider” or “AAASP” means a corporate or legal entity licensed 8 pursuant to this chapter to operate clinical AI services that 9 are subject to licensure pursuant to this chapter. 10 4. “Board” means the board of autonomous medical practice 11 created under chapter 147. 12 5. “Chronic condition” means a human disease, disorder, 13 injury, or impairment that is persistent, recurrent, or 14 reasonably expected to require ongoing or periodic clinical 15 management, monitoring, or care to maintain function, 16 prevent progression, mitigate symptoms, or reduce the risk 17 of complications. A chronic condition is primarily managed 18 through longitudinal care rather than isolated emergency 19 intervention and may experience episodic exacerbations 20 requiring temporary escalation of care. 21 6. “Clinical AI service” means any software system, 22 algorithmic model, or automated service that, whether 23 independently or in combination with human involvement, 24 performs, supports, or materially influences functions that 25 constitute the practice of medicine or other licensed clinical 26 practice with respect to a specific patient, to the extent 27 otherwise permitted under applicable law. “Clinical AI service” 28 includes advisory AI, fully autonomous AI, informational AI, 29 and supervised autonomous AI. 30 7. “Critical condition” means a disease, illness, injury, 31 or physiologic state in which one or more vital organ systems 32 is impaired, failing, or at substantial risk of failure, 33 or in which the condition presents a high probability of 34 death, permanent disability, or serious irreversible harm 35 -2- LSB 6924YC (5) 91 ss/ko 2/ 33

H.F. _____ without prompt and advanced clinical intervention. A critical 1 condition is characterized by physiologic instability, high 2 acuity, or the need for continuous monitoring, specialized 3 resources, or intensive medical management to prevent 4 catastrophic outcomes. 5 8. “Designated responsible official” means a natural person 6 designated by an AAASP who is authorized to bind the AAASP 7 for compliance and administrative matters under this chapter, 8 receive legal process and board notices, and certify filings 9 and reports required by the board. A designated responsible 10 official is not, solely by designation, deemed to be practicing 11 a licensed health care profession. 12 9. “Fully autonomous AI” means an artificial intelligence 13 authorized to independently diagnose, treat, triage, or 14 prescribe without the necessity of human supervision or 15 intervention for each distinct case. 16 10. “Informational AI” means an artificial intelligence 17 that provides aggregated data, literature, or administrative 18 information to a user but does not suggest a specific clinical 19 action. 20 11. “Materially influence” means having a reasonable 21 likelihood of being relied upon to make, modify, or forego a 22 patient-specific clinical decision or action. 23 12. “Medical director” means a licensed physician and 24 surgeon or osteopathic physician and surgeon who is designated 25 by an AAASP to provide clinical oversight of the AAASP’s 26 clinical scope, safety protocols, escalation pathways, and 27 quality assurance processes, as required by this chapter or 28 board rule. 29 13. “Noncritical condition” means a condition, illness, 30 or injury, whether acute, subacute, stable chronic, or 31 self-limiting, for which, based on reasonable clinical judgment 32 and available clinical information, a delay in definitive 33 diagnosis, initiation of treatment, or escalation of care would 34 not reasonably be expected to result in serious adverse health 35 -3- LSB 6924YC (5) 91 ss/ko 3/ 33

H.F. _____ consequences, permanent disability, or death. A noncritical 1 condition does not present objective signs of physiologic 2 instability, rapidly progressive deterioration, or the need for 3 immediate emergency or life-preserving intervention. 4 14. “Preventive” means a measure, service, or intervention 5 intended to reduce the likelihood of disease onset, 6 progression, recurrence, or complications, including wellness, 7 fitness, primary, and risk-based preventive care, whether 8 applied to a healthy individual or individual with identified 9 risk factors or existing conditions, where the primary purpose 10 is risk reduction or health maintenance rather than treatment 11 of an active acute pathology, and where the intervention is 12 generally low-risk and consistent with accepted standards of 13 care. 14 15. “Reportable event” means an adverse event, a material 15 near miss, a material malfunction affecting clinical output, or 16 a material data integrity failure affecting a patient-specific 17 clinical decision. 18 16. “Sandbox reciprocity state” means a jurisdiction 19 recognized by the board as having a substantially similar 20 regulatory testing environment for health technology. 21 17. “Supervised autonomous AI” means an artificial 22 intelligence authorized to generate and execute a clinical 23 action, diagnosis, or treatment plan under the supervision of a 24 licensed human provider who retains the ability to intervene. 25 18. “Time-sensitive condition” means a medical condition 26 or acute clinical presentation for which the effectiveness of 27 diagnosis, treatment, or intervention is materially dependent 28 on timely initiation, and for which a delay in care is 29 reasonably expected to result in rapid clinical deterioration, 30 irreversible morbidity, or death. A time-sensitive condition 31 requires accelerated recognition, triage, and escalation of 32 care based on reasonable clinical judgment and available 33 clinical information. 34 Sec. 5. NEW SECTION . 153A.2 Board —— executive director. 35 -4- LSB 6924YC (5) 91 ss/ko 4/ 33

H.F. _____ 1. An executive director of the board shall be appointed 1 pursuant to section 10A.504. The governor, with the approval 2 of the executive council pursuant to section 8A.413, subsection 3 3, under the pay plan for exempt positions in the executive 4 branch of government, shall set the salary of the executive 5 director. 6 2. The executive director may employ such other staff as 7 necessary to carry out the duties of the board. 8 3. Except as otherwise provided in this chapter or rules 9 of the board, the executive director is authorized to take 10 all actions reasonably necessary to carry out and enforce the 11 laws and rules administered by the board, including all of the 12 following: 13 a. Employ, supervise, evaluate, and discipline agency staff. 14 b. Enter into contracts, procure goods and services, and 15 make expenditures within appropriated or authorized budgets. 16 c. Establish internal organizational structure, operational 17 procedures, and administrative systems. 18 d. Receive, process, investigate, and resolve applications, 19 registrations, filings, complaints, audits, and compliance 20 matters. 21 e. Conduct investigations, issue requests for information, 22 and require the production of records as authorized by law. 23 f. Administer examinations, reviews, assessments, 24 certifications, or registrations authorized by law or rule. 25 g. Take any other administrative or operational actions 26 necessary to efficiently carry out the purposes of this 27 chapter. 28 Sec. 6. NEW SECTION . 153A.3 Fees. 29 The board shall adopt rules pursuant to chapter 17A to set 30 fees for applications, provisional licenses, license renewals, 31 and other administrative services. The fees shall be set at 32 a level sufficient to offset the costs of administering this 33 chapter. 34 Sec. 7. NEW SECTION . 153A.4 Board —— duties —— rules. 35 -5- LSB 6924YC (5) 91 ss/ko 5/ 33

H.F. _____ 1. The board shall do all of the following: 1 a. Grant, suspend, revoke, and monitor AAASP licenses of all 2 classes and types. 3 b. Establish and operate or contract for a state centralized 4 institutional review board. 5 c. Authorize and develop frameworks for delegated 6 agreements, collaborative practice agreements, and supervision 7 agreements. 8 d. Conduct or contract for algorithmic safety and bias 9 audits. 10 e. Issue a state provider identifier for billing. 11 2. The board may adopt rules pursuant to chapter 17A to do 12 all of the following: 13 a. Establish licensure standards, application procedures, 14 renewal requirements, recordkeeping, reporting, inspections, 15 audits, and compliance oversight. 16 b. Establish minimum standards of professional conduct, 17 operational compliance, and public protection applicable to 18 licensees. 19 c. Establish forms and administrative processes necessary to 20 carry out the duties of the board. 21 3. No rule that materially restricts AAASP scope of practice 22 or imposes a material barrier to market entry shall be adopted 23 without all of the following: 24 a. The affirmative vote of at least two-thirds of the voting 25 members of the board. 26 b. Written findings that a restriction created by rule is 27 supported by substantial evidence of a patient-safety risk and 28 is the least restrictive means to address that risk. 29 Sec. 8. NEW SECTION . 153A.5 Meetings of the board. 30 1. The board shall meet at least quarterly and at such 31 additional times as may be necessary to carry out the duties 32 of the board. 33 2. A meeting of the board may be called by the chair, the 34 executive director, or upon written request of a majority of 35 -6- LSB 6924YC (5) 91 ss/ko 6/ 33

H.F. _____ the board members. 1 3. The board shall annually elect from among its members a 2 chair and vice chair, who shall serve one-year terms and may 3 be reelected. 4 4. A majority of the voting members of the board shall 5 constitute a quorum for the transaction of business. An 6 affirmative vote of a majority of the members present at a 7 meeting at which a quorum is present shall be required for 8 official action of the board, unless otherwise provided by law. 9 5. All meetings of the board shall be open to the public and 10 conducted in compliance with chapters 21 and 22. The board may 11 enter executive session only as authorized by law. 12 Sec. 9. NEW SECTION . 153A.6 Licensee discipline and 13 investigations. 14 1. The board may receive complaints, conduct 15 investigations, require the production of records reasonably 16 related to compliance with this chapter, and conduct audits and 17 inspections as authorized by law and rule. 18 2. The board may issue administrative subpoenas for 19 testimony and documents in furtherance of an investigation or 20 contested case. 21 3. The board may impose discipline, including reprimand, 22 probation, restricted licensure, suspension, revocation, and 23 administrative fines. 24 4. A licensee may contest discipline issued pursuant to this 25 chapter by initiating a contested case proceeding pursuant to 26 chapter 17A. 27 Sec. 10. NEW SECTION . 153A.7 Licensure —— classes —— 28 exemptions. 29 1. An AAASP license is required for a person operating any 30 of the following: 31 a. An advisory AI that is applied to a condition that 32 is both critical and time sensitive and that is intended, 33 represented, or reasonably relied upon to guide clinical action 34 in a manner that substitutes for, rather than merely informs, 35 -7- LSB 6924YC (5) 91 ss/ko 7/ 33

H.F. _____ independent clinical judgment. 1 b. A supervised autonomous AI that is applied to a condition 2 that is both chronic and noncritical or that is both critical 3 and time sensitive, or that is applied to a preventive 4 condition when the service includes patient-specific clinical 5 orders, including but not limited to medication orders, 6 laboratory orders, or device orders as part of a licensed 7 professional health care service rendered within this state. 8 c. A fully autonomous AI. 9 2. a. An AAASP license is not required for a person 10 operating any of the following: 11 (1) An informational AI, regardless of the clinical 12 condition. 13 (2) An advisory AI that is applied to a condition that is 14 preventive or that is both chronic and noncritical. 15 (3) An advisory AI that does not independently initiate, 16 execute, modify, or discontinue a clinical action, order, 17 diagnosis, or treatment, and that is not intended, represented, 18 or reasonably relied upon as a substitute for independent 19 professional clinical judgment in the management of a critical 20 or time-sensitive condition. 21 (4) A supervised autonomous AI that is applied to preventive 22 conditions and which is not issuing patient-specific clinical 23 orders as part of a licensed professional health care service 24 rendered within this state, including but not limited to 25 medication orders, laboratory orders, or device orders. 26 b. A person who operates a system listed in paragraph “a” 27 may be issued a voluntary license by the board for the purposes 28 of reimbursement or entering into clinical practice agreements. 29 3. a. The board shall issue the following AAASP licenses, 30 each of which shall also include an autonomy modifier as 31 provided in paragraph “b” : 32 (1) For clinical AI services delivered as a 33 patient-specific professional service and regulated by 34 the state pursuant to the state’s authority over the practice 35 -8- LSB 6924YC (5) 91 ss/ko 8/ 33

H.F. _____ of medicine or other licensed clinical practice, including but 1 not limited to services operating in a manner analogous to 2 laboratory-developed tests or other proprietary algorithmic 3 diagnostic, triaging, or therapeutic services, that do not 4 rely on clearance or approval from the federal food and drug 5 administration as the basis for their lawful clinical use, a 6 class A license. 7 (2) For clinical AI services that have achieved clearance, 8 authorization, or approval as software as a medical device 9 from the federal food and drug administration, and for which 10 the federal authorization serves as the primary basis for the 11 system’s lawful clinical use, a class B license. 12 (3) For clinical AI services providing nondiagnostic 13 therapy, coaching, or monitoring, and which do not 14 independently establish a diagnosis but instead operate on the 15 basis of an existing diagnosis, referral, or patient-identified 16 condition, a class C license. 17 b. Each AAASP license shall include one of the following 18 autonomy modifiers: 19 (1) For a system otherwise exempt from licensure but for 20 which a person has voluntarily elected to obtain licensure, 21 modifier L0. 22 (2) For an advisory AI addressing critical or 23 time-sensitive conditions, modifier L1. 24 (3) For a supervised autonomous AI requiring human 25 oversight or collaborative practice agreements, modifier L2. 26 (4) For a fully autonomous AI authorized for independent 27 operation, modifier L3. 28 c. A licensee may petition the board to increase the 29 licensee’s autonomy modifier if the licensee submits safety 30 data demonstrating performance equivalent to or exceeding 31 performance benchmarks for a human, to the extent such 32 escalation is not inconsistent with federal law. 33 4. a. The board shall review an application for a license 34 under this section for completeness within thirty calendar days 35 -9- LSB 6924YC (5) 91 ss/ko 9/ 33

H.F. _____ of receipt. If the board determines that the application is 1 incomplete, the board shall inform the applicant in writing 2 of information required to complete the application, and the 3 applicant must submit the required information within ten 4 calendar days of receipt of the written request. 5 b. If the board does not notify an applicant that an 6 application is incomplete within thirty calendar days of 7 receipt, the application shall be deemed complete and the board 8 shall not deny the application based solely on information that 9 the board failed to request pursuant to paragraph “a” . 10 5. a. Except as provided in paragraph “b” , the board shall 11 grant or deny a license within ninety calendar days after 12 receipt of a complete application. 13 b. If the board ethicist determines that an applicant’s 14 proposed data collection constitutes human subjects research 15 requiring full review by the state centralized institutional 16 review board or an external institutional review board pursuant 17 to section 159.13, subsection 2, the board may extend the 18 review period by an additional thirty calendar days. The board 19 must notify the applicant of the extension in writing prior 20 to the expiration of the initial ninety-day review period. 21 The board shall not extend a review period beyond one hundred 22 twenty calendar days in total. 23 c. If the board fails to issue a final decision on an 24 application within the time period specified in paragraph “a” 25 or “b” , a provisional license shall be issued to the applicant 26 upon submission by the applicant of a sworn attestation 27 under penalty of perjury that the applicant has satisfied all 28 minimum insurance, bonding, safety, reporting, and compliance 29 requirements for provisional licensure under this chapter. A 30 provisional license issued pursuant to this paragraph is valid 31 for ninety calendar days from the date of issue, or until the 32 board issues a final decision on the application, whichever 33 occurs first. 34 Sec. 11. NEW SECTION . 153A.8 Licensure by reciprocity. 35 -10- LSB 6924YC (5) 91 ss/ko 10/ 33

H.F. _____ 1. A licensee in good standing in a sandbox reciprocity 1 state shall be eligible for licensure by reciprocity upon 2 submission of a completed application. 3 2. An applicant holding a valid clearance from the federal 4 food and drug administration for the specific use case applied 5 for shall be automatically eligible for a class B license. 6 The board may impose additional conditions of licensure under 7 this chapter, including transparency, reporting, auditing, 8 pilot-zone, and sandbox requirements, to the extent not 9 inconsistent with federal law, provided that the additional 10 conditions align with benchmarks, post-market monitoring plans, 11 and related guidelines already applicable to that applicant to 12 the maximum extent practicable. 13 3. a. The board shall grant an AAASP license to an 14 applicant who holds a current, unrestricted authorization to 15 provide substantially similar clinical AI services in another 16 state unless the board determines that any of the following 17 apply: 18 (1) The originating state’s regulatory framework is 19 materially less protective of patient safety than this state. 20 (2) The applicant is not in good standing or is subject to 21 pending disciplinary action. 22 (3) The scope of practice or autonomy level requested in 23 this state exceeds that authorized in the originating state. 24 b. The board shall not require an applicant for licensure 25 pursuant to this subsection to provide proof of satisfaction of 26 initial licensure requirements, except as necessary to verify 27 good standing, scope equivalence, and compliance with reporting 28 and transparency obligations under this chapter. 29 c. The board may require that an applicant for licensure 30 under this subsection submit documentation necessary to assess 31 substantial similarity of the originating state’s regulatory 32 framework and may impose reasonable conditions or limitations 33 to ensure patient safety and compliance with this chapter. 34 Sec. 12. NEW SECTION . 153A.9 Clinical orders —— 35 -11- LSB 6924YC (5) 91 ss/ko 11/ 33

H.F. _____ prescriptions. 1 1. An AAASP with an autonomy modifier of L2 or L3 may 2 issue patient-specific clinical orders as part of a licensed 3 professional service rendered within this state, including 4 but not limited to medication orders, laboratory orders, or 5 device orders, provided that such authority does not authorize 6 interstate marketing, distribution, or commercial sale of a 7 medical device in violation of federal law. 8 2. An AAASP with an autonomy modifier of L2 or L3 may issue 9 medication orders for prescription drugs, other than controlled 10 substances, within the AAASP’s approved scope. Dispensing 11 and drug administration shall occur only through persons or 12 entities licensed to dispense or administer medications. 13 Sec. 13. NEW SECTION . 153A.10 Disclosure requirements. 14 1. a. Prior to or at the beginning of service, an AAASP 15 operating under modifier L2 shall make the following disclosure 16 to the patient: 17 “An artificial intelligence system was used to generate and 18 execute a clinical action, diagnosis, or treatment plan under 19 the supervision of a licensed human provider who retains the 20 ability to intervene. You have the right to request a human 21 review of the decision, which may incur additional costs or 22 time.” 23 b. Paragraph “a” does not apply to an advisory AI tool that 24 provides recommendations, risk scores, alerts, or guidance 25 to a licensed human health care provider who independently 26 determines whether and how to act. 27 2. a. Prior to delivering services, an AAASP operating 28 under modifier L3 shall obtain affirmative patient 29 acknowledgment that: 30 “You are receiving care from an autonomous AI provider 31 licensed by the state. This provider is an artificial 32 intelligence system and does not include routine human clinical 33 oversight. You may seek additional or alternative care from 34 a licensed human health care provider of your choice at any 35 -12- LSB 6924YC (5) 91 ss/ko 12/ 33

H.F. _____ time.” 1 b. In addition to the disclosure required pursuant to 2 paragraph “a” , an AAASP with a provisional license operating 3 under modifier L3 shall make the following disclosure to the 4 patient: 5 “This provider is operating under a provisional state 6 license as part of a regulatory sandbox evaluating safety and 7 effectiveness. By consenting to this service, you acknowledge 8 that liability for noneconomic damages may be limited under 9 state law as provided in Iowa Code chapter 153A.” 10 Sec. 14. NEW SECTION . 153A.11 Artificial intelligence 11 augmented and autonomous service provider —— duties —— 12 restrictions. 13 1. a. An AAASP operating under modifier L2 or L3 is bound 14 by a professional duty of loyalty to each patient and must act 15 solely in the best clinical interest of the patient. 16 b. An AAASP’s professional duty of loyalty to a patient 17 requires the AAASP to prioritize the patient’s overall welfare, 18 which includes the optimization of clinical outcomes, financial 19 efficiency, care coordination, and patient convenience. An 20 AAASP violates this duty if the AAASP’s clinical logic is 21 configured to prioritize the financial interests of the AAASP 22 or the AAASP’s affiliates over a substantially similar and 23 clinically appropriate alternative that offers superior value, 24 coordination, or efficiency to the patient. 25 c. If the algorithm of a clinical AI service results in 26 a recommendation for an entity affiliated with the AAASP, 27 the AAASP satisfies the AAASP’s duty of loyalty, even if a 28 human health care provider might have reasonably chosen an 29 alternative context, if the AAASP does all of the following: 30 (1) Discloses the financial affiliation in a clear and 31 conspicuous manner at the point of recommendation. 32 (2) Presents the patient with a choice of at least two 33 nonaffiliated alternatives of similar clinical quality, 34 presented with equal visual prominence in the interface, where 35 -13- LSB 6924YC (5) 91 ss/ko 13/ 33

H.F. _____ reasonably available. 1 2. The interface through which a clinical AI service 2 interacts with a patient is a clinical space and shall not 3 display, verbally articulate, or otherwise present paid 4 commercial content, advertisements, sponsored results, or 5 third-party marketing messages within the context of a clinical 6 encounter, diagnosis, or treatment plan. An AAASP shall not 7 use conversational prompts or nudges designed to persuade a 8 patient to request a specific medication or optional commercial 9 service for the sole purpose of financial gain. 10 3. An AAASP shall not utilize weights, biases, or prompt 11 engineering to prefer an affiliated pharmacy, specialist, or 12 manufacturer unless such preference is based on an objectively 13 verifiable clinical, economic, or coordination advantages for 14 the patient, including but not limited to lower out-of-pocket 15 cost, faster time-to-treatment, superior validated outcomes, or 16 enhanced convenience through vertical integration. 17 4. a. Each AAASP shall maintain an immutable clinical logic 18 snapshot for every version of the AAASP’s algorithm deployed in 19 production, including the underlying weights, decision-logic, 20 and prompt-engineering instructions. An AAASP shall retain the 21 snapshots for a period of two years after the date of initial 22 deployment to allow for the investigation of the logic used in 23 a specific patient encounter during an audit by the board. 24 b. Upon receipt of formal notice of an investigation, an 25 AAASP shall not alter or delete any snapshot related to the 26 period of investigation. 27 5. a. The board may perform a statistical audit of an 28 AAASP’s referral and prescription patterns. A finding that an 29 AAASP recommends an affiliate at a rate significantly higher 30 than the regional average, or other appropriate clinical or 31 economic benchmarks as determined by the board, shall create a 32 rebuttable presumption of unlawful steering. 33 b. An AAASP may rebut a presumption of unlawful steering 34 by demonstrating through clinical logic snapshots that the 35 -14- LSB 6924YC (5) 91 ss/ko 14/ 33

H.F. _____ preference was driven by objective data, such as evidence that 1 the affiliate provided superior care coordination, convenience, 2 or the lowest-cost option for the patient. 3 6. An AAASP shall comply with the requirements of the 4 federal Health Insurance Portability and Accountability Act 5 of 1996, Pub. L. No. 104-191, to the extent that the AAASP 6 functions as a covered entity or business associate. 7 Sec. 15. NEW SECTION . 153A.12 Licensure —— term —— 8 restrictions. 9 1. a. An initial license as an AAASP shall be a provisional 10 license and shall be valid for a period of up to two years from 11 the date of issue. 12 b. After two years of licensure, the board shall convert 13 a provisional AAASP license to a full AAASP license upon a 14 finding that safety benchmarks, as established by the board by 15 rule, have been met, unless the board and licensee agree to 16 temporarily extend the provisional period to collect further 17 data. 18 c. A provisional licensee may submit an application, on 19 a form determined by the board, for the expedited conversion 20 of a provisional license to a full license. The board may 21 approve the expedited conversion of a provisional license to a 22 full license upon a finding that the provisional licensee has 23 clearly demonstrated that the provisional licensee meets or 24 exceeds safety and performance benchmarks. 25 2. a. The board may impose restrictions on the scope of 26 operations of a provisional AAASP licensee to facilitate phased 27 deployment, data collection, and validation of safety and 28 effectiveness. Upon conversion of a provisional AAASP license 29 to a full AAASP license, the board may maintain, modify, or 30 remove restrictions to reflect the scope within which the 31 AAASP has demonstrated sustained safety, effectiveness, and 32 compliance. 33 b. The board may impose any of the following restrictions on 34 a licensee’s provisional or full license: 35 -15- LSB 6924YC (5) 91 ss/ko 15/ 33

H.F. _____ (1) Geographic limitations, including restriction to 1 federally designated health professional shortage areas or 2 specific medically underserved counties. 3 (2) Patient volume caps. 4 (3) Scope limitations, including restriction of a clinical 5 AI service to specified disease states, conditions, or clinical 6 functions. 7 (4) Phased supervised deployment, including requirements 8 for physician review or confirmation of a defined number of 9 patient interactions, diagnoses, or treatment recommendations 10 prior to modification or removal of human supervision 11 requirements. 12 (5) Any other restrictions as determined by the board by 13 rule. 14 3. Notwithstanding any restrictions imposed on a licensee 15 pursuant to subsection 2, a licensee may provide services to 16 a patient in this state if the patient gives informed consent 17 and meets any of the following criteria, as demonstrated by 18 a referral or attestation from a physician and surgeon or 19 osteopathic physician and surgeon: 20 a. The patient resides in a federally designated health 21 professional shortage area. 22 b. The patient has been diagnosed with a severe and 23 life-threatening condition or multiple chronic conditions. 24 c. The patient has a condition from which death is likely to 25 occur within six months. 26 d. The patient has a condition or disability that causes 27 irreversible morbidity or likely substantial reduction in daily 28 function. 29 e. The patient has been determined to be at high risk for 30 a specific condition, disease, or diagnosis that the AAASP is 31 designed to detect, diagnose, or treat. 32 f. The patient is unable to obtain clinically appropriate 33 access to a human clinician within a time frame reasonably 34 related to the patient’s condition category. 35 -16- LSB 6924YC (5) 91 ss/ko 16/ 33

H.F. _____ Sec. 16. NEW SECTION . 153A.13 Application requirements. 1 1. An applicant for licensure as an AAASP shall include all 2 of the following with the application: 3 a. Proof of professional liability insurance coverage that 4 is equivalent to that required for a human specialist in the 5 same field. The insurance coverage must include tail coverage 6 for the time period specified in section 614.1, subsection 9, 7 plus one year. 8 b. A full set of fingerprints, in a form and manner 9 prescribed by the board, from all of the following people, 10 which shall be submitted to the federal bureau of investigation 11 through the state criminal history repository for a national 12 criminal history check: 13 (1) All natural persons with direct or indirect ownership of 14 ten percent or more of the AAASP. 15 (2) The designated responsible official. 16 (3) The medical director. 17 (4) Any natural person who provides unsupervised direct 18 patient care or who is authorized to independently initiate, 19 modify, or execute a patient-specific clinical actions on 20 behalf of the AAASP. 21 (5) Other categories of personnel based on demonstrated 22 risk to patient safety, data security, or program integrity, as 23 determined by the board by rule. 24 c. The name and contact information of the person who is the 25 designated responsible official of the AAASP. 26 d. For an applicant for a license under modifier L2 or L3, 27 the name and contact information of the designated medical 28 director who shall be responsible for oversight of clinical 29 scope, safety protocols, escalation procedures, and quality 30 assurance related to patient care. The medical director may be 31 the same person as the designated responsible official. 32 e. A surety bond, payable to the state, to cover claims or 33 operational failures not covered by insurance. The bond shall 34 be in an amount determined by the board by rule, but not less 35 -17- LSB 6924YC (5) 91 ss/ko 17/ 33

H.F. _____ than fifty thousand dollars. 1 2. a. In addition to the requirements of subsection 1, 2 an applicant shall submit a determination declaring whether 3 the applicant’s proposed activities constitute human subjects 4 research as provided in 45 C.F.R. pt. 46. The board ethicist 5 shall review the determination. 6 b. If the board ethicist determines that the applicant’s 7 proposed activities constitute human subjects research, 8 or the applicant opts to treat the activities as human 9 subjects research, the applicant must obtain approval from 10 the state centralized institutional review board or an 11 independent institutional review board approved by the board 12 by rule prior to obtaining a license. The state centralized 13 institutional review board shall complete its review and issue 14 a determination within thirty calendar days after receipt of a 15 completed application. 16 c. This subsection does not alter or waive any obligation 17 under 45 C.F.R. pt. 46, or applicable human-subject regulations 18 of the federal food and drug administration, when such 19 obligation applies by virtue of federal funding, federal 20 program participation, or other federal jurisdiction. 21 Sec. 17. NEW SECTION . 153A.14 Continuity plan. 22 1. Each AAASP must submit and maintain as a condition of 23 licensure a continuity plan, subject to approval by the board, 24 that details procedures for the AAASP’s insolvency, license 25 revocation, or market exit. The continuity plan must designate 26 a person to whom the AAASP will transfer all patient data, 27 consistent with the federal Health Insurance Portability and 28 Accountability Act of 1996, Pub. L. No. 104-191, in the event 29 that the AAASP ceases to operate. 30 2. Each AAASP must maintain an escrow account or bond 31 sufficient to cover the technical costs of data migration to 32 the person designated in the AAASP’s continuity plan. The 33 board may seize a bond under this subsection to execute the 34 AAASP’s continuity plan if the AAASP fails to voluntarily 35 -18- LSB 6924YC (5) 91 ss/ko 18/ 33

H.F. _____ execute the continuity plan. 1 Sec. 18. NEW SECTION . 153A.15 Safety and performance 2 benchmarking —— reporting. 3 1. The board shall adopt by rule pursuant to chapter 17A 4 objective safety and performance benchmarks that an AAASP must 5 meet or exceed to qualify for an initial license under modifier 6 L3 or to convert any provisional license to a full license. 7 2. a. Benchmarks adopted by the board shall be designed 8 to ensure that the AAASP demonstrates clinical competency, 9 accuracy, and safety outcomes that meet or exceed the 10 performance of a reasonably prudent human health care provider 11 practicing in the same or similar specialty. 12 b. Benchmarks adopted by the board may include clinically 13 validated testing, subgroup performance evaluation, 14 calibration, false positive and false negative rates 15 appropriate to the intended use, and real-world outcome 16 measures. The board may recognize external evaluation 17 frameworks by guidance. 18 c. To the maximum extent practicable, the board shall align 19 the benchmarks adopted by the board with federal benchmarks 20 established for class B AAASP licensees and with benchmarks 21 in other states with a similar regulatory framework for AAASP 22 licensure. 23 3. As a condition of license renewal, an AAASP shall submit 24 an annual performance report demonstrating that the clinical 25 AI service used by the AAASP continues to meet the safety 26 benchmarks in effect at the time of the AAASP’s immediately 27 preceding licensure. The board may suspend an AAASP’s license 28 if data indicates a degradation in the AAASP’s safety outcomes. 29 A licensee shall report adverse and reportable events as part 30 of the annual performance report. 31 Sec. 19. NEW SECTION . 153A.16 Scope of practice —— waivers 32 —— standard of care. 33 1. A clinical AI service or act is within the authorized 34 scope of practice of a licensed AAASP if all of the following 35 -19- LSB 6924YC (5) 91 ss/ko 19/ 33

H.F. _____ apply: 1 a. The AI clinical service or act is consistent with and not 2 expressly prohibited by this chapter or the limitations of the 3 specific license class and modifier held by the AAASP. 4 b. The AI clinical service or act is consistent with the 5 clinical AI service’s validated technical specifications, 6 training data, intended use case, and performance parameters as 7 submitted to the board. 8 c. The performance of the AI clinical service or act is 9 within the accepted standard of care for the specific clinical 10 task that would be provided in the same or similar clinical 11 setting by a reasonable and prudent human health care provider 12 with the same or similar specialty specialization. 13 2. Any prohibition on the corporate practice of medicine or 14 any other licensed clinical practice is waived solely to the 15 extent necessary to permit an AAASP to hold an AAASP license 16 and to bill for clinical AI services authorized under this 17 chapter. This subsection shall not be construed to authorize 18 a person or entity to control the independent professional 19 judgment of a licensed human health care provider or alter 20 corporate practice restrictions applicable to human clinical 21 services. 22 3. A provider-patient relationship exists when a licensed 23 AAASP delivers a clinical AI service to a specific patient 24 and the patient reasonably relies on that clinical AI service 25 for health care decision making, and such provider-patient 26 relationship shall give rise to professional duty, standard 27 of care, confidentiality, and civil liability as otherwise 28 provided by law. 29 4. The designation of a person as a medical director 30 does not constitute the practice of medicine with respect to 31 individual patient encounters conducted by an AAASP, and does 32 not create professional liability for the outputs of an AAASP 33 acting within the scope of this chapter. 34 5. For an AAASP with a provisional license and in 35 -20- LSB 6924YC (5) 91 ss/ko 20/ 33

H.F. _____ substantial compliance with the disclosure requirements of 1 section 153A.10, noneconomic damages shall be limited as 2 provided in section 147.136A, except when the act or omission 3 constitutes gross negligence, reckless disregard, or willful 4 misconduct. 5 6. This chapter shall not be construed to authorize any 6 natural person to engage in conduct outside the scope of that 7 person’s professional license. Authority granted to an AAASP 8 does not confer practice authority on any unlicensed individual 9 involved in development, deployment, operation, or support of 10 a clinical AI service. 11 Sec. 20. NEW SECTION . 153A.17 Discipline —— limitations. 12 1. The board has exclusive authority to regulate, license, 13 investigate, and discipline AAASPs and the delivery of 14 clinical AI services authorized under this chapter. No other 15 state licensing board shall impose licensure requirements, 16 supervision requirements, disciplinary action, or rules 17 of professional conduct that have the purpose or effect of 18 restricting, prohibiting, or conditioning the lawful use of, 19 reliance upon, or participation in services provided by a 20 licensed AAASP acting within the scope of this chapter. 21 2. This section does not limit the authority of a state 22 licensing board to regulate the independent professional 23 conduct of a natural person within that board’s jurisdiction. 24 If, in the course of an investigation, the board identifies 25 evidence of potential misconduct by a licensed human 26 practitioner that is independent of and not solely attributable 27 to lawful AAASP operation, the board may refer such matter to 28 the appropriate licensing board for review. 29 Sec. 21. NEW SECTION . 153A.18 Unlawful practice —— title 30 protection —— enforcement. 31 1. A person or entity shall not offer, operate, market, 32 or deploy a clinical AI service requiring licensure under 33 this chapter without a valid AAASP license issued under this 34 chapter. 35 -21- LSB 6924YC (5) 91 ss/ko 21/ 33

H.F. _____ 2. A person or entity shall not falsely represent or imply 1 through the use of any words, letters, or symbols that the 2 person or entity holds an AAASP license, license class, or 3 autonomy modifier. 4 3. A person or entity shall not knowingly aid, abet, or 5 facilitate unlicensed practice prohibited by this section. 6 4. The board may issue cease and desist orders and may 7 request the attorney general bring an action for injunctive 8 relief to enforce this chapter. 9 5. The board may impose a civil penalty not to exceed one 10 thousand dollars per violation per day of a violation of this 11 chapter or rules adopted by the board, in addition to any other 12 remedy authorized by law. 13 Sec. 22. NEW SECTION . 153A.19 Reimbursement. 14 1. The department of health and human services, in the 15 department’s capacity as the state administrator of Medicaid, 16 and the insurance division shall collaborate with the board 17 to develop reimbursement codes, pilot programs, or coverage 18 determinations for licensed AAASPs. The department of health 19 and human services, in the department’s capacity as the state 20 administrator of Medicaid, and the insurance division may 21 each adopt rules pursuant to chapter 17A to implement this 22 subsection. 23 2. The board shall issue a unique state provider identifier 24 to every licensed AAASP for use in claiming reimbursement from 25 a state payer program whenever a federal national provider 26 identifier is unavailable or technically inapplicable. 27 3. Reimbursement for claims submitted under a state 28 provider identifier by a provider without a corresponding 29 federal national provider identifier or recognition from the 30 federal centers for Medicare and Medicaid services shall be 31 funded exclusively through moneys appropriated from the general 32 fund of the state, or other sources of nonfederal funds, except 33 as provided in subsection 4. 34 4. A claim for AAASP services shall not be submitted for 35 -22- LSB 6924YC (5) 91 ss/ko 22/ 33

H.F. _____ federal matching funds unless the federal centers for Medicare 1 and Medicaid services issues written guidance confirming 2 eligibility, or otherwise makes clear through guidance or 3 establishment of billing protocols, that federal matching funds 4 are available for the AAASP services. 5 5. Reimbursement for AAASP services shall be based on 6 value-based care or capitation models unless the payer and 7 board jointly determine in writing that value-based care or 8 capitation models are impractical. 9 Sec. 23. NEW SECTION . 153A.20 Exclusions —— compliance with 10 federal law. 11 1. This chapter does not prohibit, restrict, or require 12 licensure for development, ownership, or private operation of 13 artificial intelligence models, provided such models are not 14 marketed or deployed as clinical AI services for patient care. 15 2. This chapter does not authorize conduct that is expressly 16 prohibited by federal law or that would place a licensee 17 in conflict with the Federal Food, Drug, and Cosmetic Act, 18 the state uniform controlled substances Act, or the federal 19 Controlled Substances Act. 20 3. This chapter does not authorize the distribution of a 21 commercial medical device in violation of the Federal Food, 22 Drug, and Cosmetic Act. A class C license issued under this 23 chapter authorizes the professional delivery of therapeutic 24 services via artificial intelligence, which constitutes the 25 practice of medicine within this state, and is distinct from 26 the commercial sale of a medical device. 27 Sec. 24. NEW SECTION . 505.36 Artificial intelligence 28 augmented and autonomous service providers —— reimbursement. 29 1. Not later than one hundred eighty days after the 30 effective date of this Act, the commissioner of insurance shall 31 adopt rules pursuant to chapter 17A, and issue subregulatory 32 guidance as necessary for the integration of artificial 33 intelligence augmented and autonomous service providers as 34 defined in section 153A.1, into conducting the business of 35 -23- LSB 6924YC (5) 91 ss/ko 23/ 33

H.F. _____ insurance in this state. The rules adopted and subregulatory 1 guidance issued pursuant to this subsection shall do all of the 2 following: 3 a. Establish that an artificial intelligence augmented 4 and autonomous service provider, with a valid modifier L2 5 or L3 license issued pursuant to chapter 159, constitutes a 6 recognized provider type under would be federally regulated 7 state-regulated health plans, health policies, and health 8 carriers. 9 b. Designate appropriate billing mechanisms, which may 10 include the use of current procedural terminology codes with 11 specific modifiers identifying the service as delivered by 12 an artificial intelligence, or the adoption of new distinct 13 billing codes as new billing codes become available. 14 c. Prohibit health carriers from denying coverage for a 15 medically necessary service solely because the service was 16 provided by a licensed artificial intelligence augmented and 17 autonomous service provider, if coverage would be provided for 18 the same service if delivered by a human health care provider. 19 d. Outline standards for including artificial intelligence 20 augmented and autonomous service providers in provider 21 networks, including credentialing requirements appropriate 22 for automated systems rather than the practice history of an 23 individual human practitioner. 24 2. The commissioner of insurance shall consult with the 25 board of autonomous medical practice to ensure clinical 26 consistency, and with the department of health and human 27 services to ensure alignment with public health goals. 28 3. This section applies to health policies, health plans, 29 and health carriers to the extent permitted by state and 30 federal law. 31 EXPLANATION 32 The inclusion of this explanation does not constitute agreement with 33 the explanation’s substance by the members of the general assembly. 34 This bill relates to the licensure of artificial 35 -24- LSB 6924YC (5) 91 ss/ko 24/ 33

H.F. _____ intelligence augmented and autonomous service providers 1 (AAASP), defined in the bill as a corporate or legal entity 2 licensed pursuant to the bill to operate clinical artificial 3 intelligence services that are subject to licensure. The bill 4 establishes the board of autonomous medical practice (board) 5 to regulate the practice of AAASPs. The board consists of one 6 member licensed to practice medicine and surgery or osteopathic 7 medicine and surgery, one member licensed to practice pharmacy, 8 one member who is a registered nurse or advanced practice 9 registered nurse, one member licensed to practice psychology, 10 one member who is a representative of a hospital association 11 or the chief executive officer of a hospital in this state, 12 one member who is a health care ethicist with an advanced 13 degree or significant professional experience in medical ethics 14 or bioethics, four at-large members who have demonstrated 15 expertise in health technology, artificial intelligence, 16 systems engineering, health care administration, patient 17 safety, or health care regulatory affairs, and one member who 18 is not a medical professional and who represents the general 19 public. 20 The bill requires the director of the department of 21 inspections, appeals, and licensing to appoint an executive 22 director for the board, whose salary shall be set by the 23 governor, with the approval of the senate and consistent with 24 the pay plan for exempt positions in the executive branch of 25 government. The executive director may employ such staff 26 as necessary to carry out the duties of the board and take 27 those actions that are reasonably necessary to carry out and 28 enforce the laws and rules administered by the board, except as 29 otherwise provided by law or rules of the board. 30 The bill requires the board to adopt rules to set fees to 31 offset administration of the bill. The bill also requires 32 the board to do all of the following: grant, suspend, 33 revoke, and monitor AAASP licenses; establish and operate or 34 contract for a state centralized institutional review board to 35 -25- LSB 6924YC (5) 91 ss/ko 25/ 33

H.F. _____ review activities of licensees that may constitute research 1 on humans; authorize and develop frameworks for practice 2 agreements; conduct or contract for algorithmic safety and bias 3 audits; and issue a state provider identifier for insurance 4 billing. The bill allows the board to adopt rules related 5 to licensing and professional standards. The bill prohibits 6 the board from adopting a rule that materially restricts the 7 practice of AAASPs or imposes a material barrier to entry to 8 the AAASP market unless the board approves the rule by at 9 least a two-thirds vote and publishes written findings that 10 the restriction is supported by substantial evidence of a 11 patient-safety risk and is the least restrictive means to 12 address that risk. 13 The bill requires the board to meet at least quarterly and at 14 such additional times as necessary to carry out its duties. A 15 meeting of the board may be called by the executive director, 16 by the chair who shall be elected annually by the board, or 17 upon written request of a majority of board members. Meetings 18 of the board are subject to open meeting and public records 19 requirements. The bill allows the board to receive complaints, 20 conduct investigations, and issue discipline against licensees. 21 The bill allows a licensee to contest discipline as a contested 22 case proceeding. 23 The bill requires a person to obtain an AAASP license 24 to provide services using a fully autonomous AI in any 25 circumstance, or an advisory or supervised autonomous AI in 26 certain circumstances listed in the bill. The bill defines a 27 fully autonomous AI as an artificial intelligence authorized 28 to independently diagnose, treat, triage, or prescribe without 29 the necessity of human supervision or intervention for each 30 distinct case; a supervised autonomous AI as an artificial 31 intelligence authorized to generate and execute a clinical 32 action, diagnosis, or treatment plan under the supervision 33 of a licensed human provider who retains the ability to 34 intervene; and an advisory AI as artificial intelligence that 35 -26- LSB 6924YC (5) 91 ss/ko 26/ 33

H.F. _____ analyzes patient-specific data to generate options, potential 1 diagnoses, risk stratification, or therapeutic suggestions to 2 a licensed health care provider or user, where such output 3 is intended to inform but not substitute for independent 4 clinical judgment, and where the provider or user is expected 5 to review, contextualize, and determine whether and how to 6 act upon the suggestion for each patient encounter. The bill 7 does not require a license for the provision of services using 8 an informational AI, defined in the bill as an artificial 9 intelligence that provides aggregated data, literature, or 10 administrative information to a user but does not suggest a 11 specific clinical action. 12 The bill creates multiples classes of AAASP license, 13 each of which shall include a modifier based on the level of 14 autonomy employed by the artificial intelligence operated by 15 the licensee. The bill requires an AAASP providing services 16 that are analogous to services provided by licensed health 17 professionals using an artificial intelligence that has not 18 received federal clearance to obtain a class A license. For 19 an AAASP using an artificial intelligence that has received 20 federal clearance the bill requires a class B license. For 21 clinical AI services providing nondiagnostic therapy, coaching, 22 or monitoring, and which do not independently establish a 23 diagnosis, the bill requires an AAASP to receive a class C 24 license. The bill also establishes four levels of autonomy 25 modifiers for AAASP licenses, including a level for AAASPs 26 that are not required to obtain a license but voluntarily 27 choose to do so. The bill allows an AAASP with the highest or 28 second-highest level of autonomy modifier to issue clinical 29 orders, and orders for prescription drugs other than controlled 30 substances. 31 The bill requires the board to review an application for 32 a license for completeness within 30 days of receipt of 33 the application. If the board does not request additional 34 information within that time period, the board is prohibited 35 -27- LSB 6924YC (5) 91 ss/ko 27/ 33

H.F. _____ from denying an application on the basis that the application 1 is incomplete. The bill requires the board to issue a 2 final decision on a license application within 90 days of 3 receipt of a complete application unless the board ethicist 4 determines that an applicant’s proposed data collection 5 constitutes human subjects research requiring full review by 6 the state centralized institutional review board or an external 7 institutional review board. If the board fails to issue a 8 decision on an application within the time period required by 9 the bill, the bill requires the board to issue a provisional 10 license upon submission by the applicant of a sworn attestation 11 under penalty of perjury that the applicant has satisfied all 12 minimum insurance, bonding, safety, reporting, and compliance 13 requirements for provisional licensure. The bill also includes 14 provisions for licensure by reciprocity. 15 The bill requires an AAASP with the highest or 16 second-highest level of autonomy modifier to make disclosures 17 and receive informed consent from patients prior to providing 18 services. The bill also imposes a professional duty of 19 loyalty on an AAASP with the highest or second-highest level 20 of autonomy modifier that requires the AAASP to prioritize the 21 patient’s overall welfare, which includes the optimization of 22 clinical outcomes, financial efficiency, care coordination, and 23 patient convenience. The bill prohibits the interface through 24 which an artificial intelligence interacts with a patient from 25 presenting paid commercial content, advertisements, sponsored 26 results, or third-party marketing messages within the context 27 of a clinical encounter, diagnosis, or treatment plan. The 28 bill requires an AAASP to maintain an immutable clinical 29 logic snapshot for every version of its algorithm deployed in 30 production, including the underlying weights, decision-logic, 31 and prompt-engineering instructions for a period of two years. 32 The bill allows the board to perform statistical audits of an 33 AAASP’s referral and prescription patterns. The bill requires 34 an AAASP to comply with the requirements of the federal Health 35 -28- LSB 6924YC (5) 91 ss/ko 28/ 33

H.F. _____ Insurance Portability and Accountability Act of 1996. 1 Under the bill, an initial license issued to an AAASP shall 2 be provisional and valid for a period of two years, unless the 3 board and licensee agree in writing to extend the period of 4 provisional licensure or the licensee submits an application 5 for expedited conversion of the provisional license to a full 6 license. The bill allows the board to impose restrictions on 7 the scope of operations of a provisional licensee in order to 8 facilitate phased deployment, data collection, and validation 9 of safety and effectiveness. The bill allows the board to 10 maintain, modify, or remove restrictions upon the conversion of 11 a provisional license to a full license to reflect the scope 12 within which the AAASP has demonstrated sustained safety, 13 effectiveness, and compliance. The bill includes specific 14 restrictions that the board may impose on a licensee, and 15 allows the board to impose other restrictions as determined by 16 the board by rule. Notwithstanding any restrictions imposed by 17 the board on a licensee, the bill allows a licensee to provide 18 services to a patient in this state who provides informed 19 consent and meets certain criteria listed in the bill, as 20 demonstrated by a referral or attestation from a physician and 21 surgeon or osteopathic physician and surgeon. 22 The bill requires an applicant for licensure to submit 23 proof of professional liability insurance coverage that is 24 equivalent to that required for a human specialist in the same 25 field. The insurance coverage must include tail coverage 26 for a period of time equal to the statute of limitations 27 for medical malpractice claims plus one year. The applicant 28 must also submit fingerprints from certain individuals for 29 the performance of a criminal background check, the name and 30 contact information of the person who is designated responsible 31 official of the AAASP, and a surety bond payable to the 32 state to cover claims or operational failures not covered 33 by insurance, in an amount determined by the board by rule, 34 but not less than $50,000. In addition, an applicant for a 35 -29- LSB 6924YC (5) 91 ss/ko 29/ 33

H.F. _____ license under the highest or second-highest level of autonomy 1 modifier shall submit the name and contact information of the 2 designated medical director, who shall be responsible for 3 oversight of clinical scope, safety protocols, escalation 4 procedures, and quality assurance related to patient care. 5 The medical director may be the same person as the designated 6 responsible official. The bill also requires an applicant to 7 submit a determination as to whether the applicant’s proposed 8 activities constitute human subjects research under federal 9 law. If the board ethicist determines that the applicant’s 10 proposed activities constitute human subjects research, or if 11 the applicant opts to treat the activities as human subjects 12 research, the applicant must obtain approval from the state 13 centralized institutional review board or an independent 14 institutional review board approved by the board by rule prior 15 to obtaining a license. 16 As a condition of licensure, the bill requires an AAASP to 17 submit and maintain a continuity plan, subject to approval by 18 the board. The bill requires the continuity plan to detail 19 procedures for the AAASP’s insolvency, license revocation, or 20 market exit, including a plan for the transferal of patient 21 data to a third party. The bill also requires an AAASP to 22 maintain an escrow account or bond sufficient to cover the 23 technical costs of data migration, which the board may seize 24 to execute the AAASP’s continuity plan if the AAASP fails to 25 voluntarily execute the continuity plan. 26 The bill requires the board to adopt by rule objective safety 27 and performance benchmarks that an AAASP must meet or exceed 28 to qualify for an initial license under the highest autonomy 29 modifier or to convert any provisional license to a full 30 license. The benchmarks shall be designed to ensure that the 31 AAASP demonstrates clinical competency, accuracy, and safety 32 outcomes that meet or exceed the performance of a reasonably 33 prudent human health care provider practicing in the same or 34 similar specialty. To the maximum extent practicable, the 35 -30- LSB 6924YC (5) 91 ss/ko 30/ 33

H.F. _____ bill requires the board to align the benchmarks with federal 1 benchmarks established for class B AAASP licensees and with 2 benchmarks in other states with a similar regulatory framework 3 for AAASP licensure. As a condition of license renewal, the 4 bill requires an AAASP to submit an annual performance report 5 demonstrating that the clinical AI service used by the AAASP 6 continues to meet the safety benchmarks established at the 7 time of the AAASP’s previous licensure, including adverse and 8 reportable events as defined in the bill. 9 The bill specifies that a clinical AI service or act is 10 within the authorized scope of practice of a licensed AAASP 11 if the service or act is consistent with and not expressly 12 prohibited by this chapter or the limitations of the specific 13 license class and modifier held by the AAASP; the service or 14 act is consistent with the clinical AI service’s validated 15 technical specifications, training data, intended use case, 16 and performance parameters as submitted to the board; and 17 performance of the service or act is within the accepted 18 standard of care for the specific clinical task that would 19 be provided in the same or similar clinical setting by a 20 reasonable and prudent human health care provider with the 21 same or similar specialty specialization. The bill waives 22 prohibitions on the corporate practice of medicine or any other 23 licensed clinical practice solely to the extent necessary to 24 permit an AAASP to hold an AAASP license and to be reimbursed 25 for clinical AI services authorized under the bill. 26 The bill creates a provider-patient relationship when a 27 licensed AAASP delivers a clinical AI service to a specific 28 patient and the patient reasonably relies on that service for 29 health care decision making, and such relationship gives rise 30 to a professional duty, standard of care, confidentiality, 31 and civil liability as otherwise provided by law. The 32 designation of a person as a medical director does not 33 constitute the practice of medicine with respect to individual 34 patient encounters conducted by an AAASP. The bill limits 35 -31- LSB 6924YC (5) 91 ss/ko 31/ 33

H.F. _____ the liability for noneconomic damages for a provisional 1 licensee who is in substantial compliance with the disclosure 2 requirements of the bill to amounts specified in Code section 3 147.136A (noneconomic damage awards against health care 4 providers), unless the act or omission constitutes gross 5 negligence, reckless disregard, or willful misconduct. 6 The bill grants the board exclusive authority to regulate, 7 license, investigate, and discipline AAASPs, and to regulate 8 the delivery of clinical AI services authorized under the bill. 9 The bill does not limit the authority of a state licensing 10 board to regulate the independent professional conduct of 11 natural persons within that board’s jurisdiction. The bill 12 prohibits a person from representing that the person has an 13 AAASP license or modifier that the person does not have. The 14 board may issue cease and desist orders and may request the 15 attorney general to bring an action for injunctive relief to 16 enforce the bill and may impose a civil penalty not to exceed 17 $1,000 per violation per day. 18 The bill requires the department of health and human 19 services, acting in its capacity as the state administrator 20 of Medicaid, and the insurance division to collaborate with 21 the board to develop reimbursement codes, pilot programs, 22 or coverage determinations for licensed AAASPs. The bill 23 requires that reimbursement for claims submitted under a state 24 provider identifier by a provider without a corresponding 25 federal national provider identifier, or recognition from the 26 federal centers for Medicare and Medicaid services, be funded 27 exclusively through appropriations from the general fund of 28 the state or other sources of nonfederal funds. Claims may be 29 paid from federal funds if the federal centers for Medicare 30 and Medicaid services issues written guidance confirming 31 eligibility or otherwise makes clear through guidance or 32 establishment of billing protocols that federal matching 33 funds are available for the services. The bill also requires 34 reimbursement for AAASP services to be based on value-based 35 -32- LSB 6924YC (5) 91 ss/ko 32/ 33

H.F. _____ care or capitation models unless the payer and board jointly 1 determine in writing that value-based care or capitation models 2 are impractical. 3 The bill does not prohibit, restrict, or require licensure 4 for the development, ownership, or private operation of 5 artificial intelligence models, provided such models are not 6 marketed or deployed as clinical AI services for patient 7 care. The bill does not authorize conduct that is expressly 8 prohibited by federal law or that would place a licensee 9 in conflict with the Federal Food, Drug, and Cosmetic 10 Act, the state uniform controlled substances Act, or the 11 federal Controlled Substances Act, nor does it authorize the 12 distribution of a commercial medical device in violation of the 13 Federal Food, Drug, and Cosmetic Act. 14 The bill requires the commissioner of insurance, in 15 consultation with the board and the department of health and 16 human services, to adopt rules and issue subregulatory guidance 17 as necessary to integrate AAASPs into conducting the business 18 of insurance in this state. The rules and guidance shall 19 establish that an AAASP under the highest or second-highest 20 autonomy modifier constitutes a recognized provider type under 21 state-regulated health policies, health plans, and health 22 carriers; designate appropriate billing mechanisms which may 23 include the use of existing current procedural terminology 24 codes with specific modifiers identifying the service as 25 delivered by an artificial intelligence, or the adoption of 26 new distinct billing codes as they become available; prohibit 27 health insurance carriers from denying coverage for a medically 28 necessary service solely because the service was provided 29 by an AAASP, and outline standards for including artificial 30 intelligence augmented and autonomous service providers in 31 provider networks, including credentialing requirements that 32 are appropriate for automated systems. 33 -33- LSB 6924YC (5) 91 ss/ko 33/ 33