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What Public Health Leaders Need to Know About HTI-2 Proposed Rule

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What Public Health Leaders Need to Know About HTI-2 Proposed Rule How Proposed HTI-2 Rule Will Benefit Public Health Data Exchange Lillian Colasurdo, Lana McKinney, Alexandra Woodward Read how the HTI-2 rule improves upon HTI-1 standards and criteria for data exchange among public health, health care, and data providers to benefit public health. On July 10, 2024 HHS’s Assistant Secretary for Technology Policy/Office of the National Coordinator of Health Information Technology (ASTP) published the proposed rule: Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2). This rule, which advances interoperability and supports access, exchange, and use of electronic health information (EHI), represents a significant step towards strengthening public health data infrastructure and promotes interoperability between health care and public health entities. It proposes significant changes impacting public health agencies (PHAs) and removing barriers to EHI exchange, while attempting to streamline health IT processes. Background Two of the most significant federal laws passed in the past fifteen years for health data exchange are the Health Information Technology for Economic and Clinical Health (HITECH) Act and the 21st Century Cures Act. Together, these laws provided ASTP with authority to set standards for and certify heath information technology. ASTP’s certification program mandates that electronic health records (EHR) comply with the new standards and eligible providers and hospitals must use certified technology to be fully reimbursed by the Centers for Medicare & Medicaid Services. Additionally, these laws grant ASTP rulemaking authority. Earlier this year, ASTP finalized the HTI-1 rule, taking substantial steps toward improving public health and health care data exchange. This rule requires EHR systems to support either HL7 Clinical Document Architecture (CDA) or Fast Healthcare Interoperability Resources (FHIR) standards for electronic case reporting, both of which enhance the data quality and timeliness for public health reporting. HTI-1 also directs EHR developers to track and report on the amount of data electronically submitted to Immunization Information Systems (IISs); that information helps improve vaccine product distribution and availability. While the rule sets the stage for a future transition to a FHIR-based approach for case reporting, there must be an adequate transition period for public health agencies. While HTI-1 took significant steps toward improving the way data is exchanged, primarily in the health care setting, the proposed rule HTI-2 aims to expand these standards to further benefit public health. The HTI-2 expands upon the interoperability standards established in HTI-1 and aims to improve interoperability by revising the ONC Health IT Certification Program. It specifically proposes two new sets of certification criteria for IT developers that will benefit public health entities and payers. Public health agencies face many barriers to efficiently exchanging data with health care providers and other entities including lack of common data standards, inconsistent reporting requirements, limited system interoperability, and inadequate public health data infrastructure. HTI-2 addresses these challenges by establishing certification criteria for public health technologies, creating a common floor to support data exchange. In addition, HTI-2 introduces changes to the Information Blocking Rule and provides transparency to Trusted Exchange Framework and Common Agreement (TEFCA) requirements. Micky Tripathi - What PH Leaders Must About HTI-2 Proposed Rule Key HTI-2 Provisions Certification Criteria, Standardizing Application Programming Interfaces (APIs) HTI-2 proposes four standards and certification criteria that may impact public health systems. Depending on the criteria, ASTP proposes that many of them be implemented by the beginning of 2027 and 2028. Updating naming conventions and standards for existing functional criteria. There are currently nine functional (or “f”) criteria EHRs must meet to exchange data with public health agencies. The updated naming conventions and standards point EHR vendors and public health systems to the latest standards for implementation. Additionally, these updates include two new criteria for birth reporting and bi-directional exchange with a prescription drug monitoring program. Establishing new certification “f” criteria for Health IT so Public Health certified systems can receive, validate, parse, and filter standardized data. These functions will apply to immunization, syndromic, laboratory, cancer pathology, case, birth, and prescription drug monitoring program data. Adopting the United States Core Data for Interoperability (USCDI) version 4, a standardized set of health data classes and elements for interoperable health information exchange. Version 4 includes several new data elements relevant to public health, such as health status assessments (e.g., alcohol and substance use). Standardizing HL7 FHIR-based API for public health data exchange by creating new certification criteria to support ongoing development and transition to FHIR for patient and population-level data exchange. CDC and ASTP have noted potential benefits of increasing public health access to critical data while reducing the reporting burden on both health care organizations and developers. HTI-2 proposes similar certification standards and alignment for reporting to payers that comply with existing CMS API requirements. Information Blocking Updates The Information Blocking Rule requires that patients have timely access to their own electronic health records and prohibits health care providers and networks, HIEs, and developers from interfering with said access. When a public health agency serves as a provider, it is crucial to ensure that patients can access records in compliance with the existing rule. HTI-2 clarifies what constitutes “interfering” with the access and exchange and provides a non-exhaustive list of examples. HTI-2 also proposes a new exception to information blocking—the Protected Care Access Exception—that would “apply to acts or omissions likely to interfere with access, exchange, or use of particular EHI that an actor believes could create a risk of exposing patients, care providers, and other persons who assist in access or delivery of health care to potential administrative, civil, or criminal investigations or other actions on certain bases.” This exception is particularly relevant for jurisdictions with more restrictive laws for sharing reproductive health data. TEFCA Governance Rules As ASTP and its Recognized Coordinating Entity (RCE), the Sequoia Project, seek to establish standards for implementing the Trusted Exchange Framework and Common Agreement (TEFCA), the proposed HTI-2 rule would codify one portion of the framework by establishing the qualifications for Qualified Health Information Networks (QHINs), onboarding and designation processes, the attestation process, termination and appeal rights, and ASTP’s formal authority to delegate responsibility to the RCE. Conclusion The HTI-2 proposed rule represents a significant step towards strengthening public health data infrastructure and promotes interoperability between health care and public health entities. It is specifically designed to “address gaps in public health data and help the nation become response-ready, promote health equity, and improve health outcomes for all.” The Joint Public Health Informatics Taskforce (JPHIT), coordinated by ASTHO and consisting of 14 member organizations including public health associations, gathered comments and input from constituent members and submitted consolidated feedback on the proposed rule in October and awaits responses and the final rule from ASTP. OE22-2203 PHIG article yes

2023 Legislative Session Update: Part Two

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Iowa,

A mid-session legislative update on five of ASTHO's top 10 public health state policy issues to watch in 2023: data privacy and modernization, reproductive health, health equity, strengthening public health agencies, and immunization.

Data Exchange to Save Lives: IIS and HIE Relationships & The Laws Protecting Public Health Data

Two reports explore opportunities for improved public health action through immunization data sharing with health information exchanges, in addition to the broader legal landscape of public health data.

ASTHO’s 2024 Legislative Session Update: Part One

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STIs,

ASTHO’s 2024 Legislative Session Update: Part One legislative session, state policy, data collection, domestic violence, health information exchange, data privacy, substance misuse, overdose prevention, sexually transmitted infections, reproductive health, contraceptive care, climate change, public health, protect data, user data, personal data, centers for disease control, disease control and prevention, social media, data management, primary care, health organizations, higher risk, family planning, data sources, astho, association of state and territorial health officials Lillian Colasurdo, Maggie Davis, Lana McKinney, JoAnne McClure This past December, ASTHO announced the top 10 public health state policy issues to watch for during the 2024 state and territorial legislative sessions. With at least 30 states concluding their regularly scheduled 2024 sessions, here is a brief update on five of the topics to watch. Data Collection and Exchange As expected, there was an increase in proposed legislation that specifically advances electronic health data access, encourages interoperability, and safeguards identifiable patient health records; this was particularly true for vital records. Hundreds of bills have been introduced this session addressing state vital records systems. The state of Illinois alone has already passed several bills, including HB 2856, which requires veteran status to be designated on death certificates, and HB 2841, which prohibits the assessment of fees to victims of domestic violence who are seeking a certified vital record (birth or death certificate) from the state. Other states such as Arizona (SB 1252) considered legislation that would require the Department of Health to provide vital records information on deceased individuals to the qualifying health information exchange (HIE). Arizona is one of eight jurisdictions (AZ, FL, IA, IL, NH, NJ, OK, and WV) that have proposed legislation addressing HIEs this session. Most of these bills increase requirements to connect to HIEs, but New Hampshire HB 1663 and Oklahoma HB 3556 would allow patients and health care providers to opt out of HIEs. As many states look to address health data privacy concerns, New Hampshire recently passed a constitutional amendment granting the explicit right to privacy and has introduced HB 1663, which would update many of the state’s privacy laws regarding medical records to conform with the constitutional requirements. Just next door, Maine considered legislation (LD 1902) that would strengthen privacy requirements for reproductive and gender-affirming patient health information. Finally, the launch of the new federal Trusted Exchange Framework and Common Agreement (TEFCA) led to the Florida legislature proposing SB 668, which, had it passed, would have required hospitals to make patient records available through a nationally recognized trusted exchange framework. It would also have required the Agency for Health Care Administration to adopt relevant rules. Substance Misuse and Overdose Prevention Measures to prevent substance misuse and reduce overdoses, namely increasing access to opioid antagonists, such as naloxone and regulating substances with the potential for misuse, are priorities this legislative season. ASTHO anticipated that states would consider legislation to reduce fatal overdoses including decriminalizing drug checking equipment, expanding naloxone access and distribution, establishing overdose prevention centers, and establishing state regulatory frameworks for commercial substances with the potential for misuse, including kratom and Delta-8. Current legislative priorities to expand access to naloxone include public spaces, such as libraries, schools, workplaces. Island jurisdictions along with at least four states—Colorado (HB 24-1003), Tennessee (SB 2141), Virginia (HB 732), and Wisconsin (AB 223)—passed legislation to provide greater access to and/or proper storage of naloxone in school settings. Additionally, Virginia passed HB 342 that requires naloxone access in state agency buildings. These legislative actions, along with the approval last year by the FDA of two non-prescription naloxone spray products for over-the-counter use, are collectively powerful policy shifts to expand access to naloxone. In an attempt to regulate substances with the potential for abuse or misuse, specifically kratom, eight states have considered legislation that would restrict the sale to people under the age of 18. Similarly, twelve states have considered legislation that would restrict the sale of kratom to those under the age of 21. At least 22 states have considered legislation that would compel specific labeling requirements for kratom. Of those, California (AB 2365) and New Jersey (A 1188) would require kratom products to be registered with the state health department annually and require lab testing of the product to meet certain qualifications. Preventing Sexually Transmitted Infections ASTHO has spotlighted the growing concerns of rising rates of sexually transmitted infections and state actions reducing congenital syphilis rates and expanding access to HIV prophylaxis (PrEP) and post-exposure prophylaxis (PEP). Rates of both syphilis and congenital syphilis continue to rise at an alarming rate, with more than 10 times as many babies being born with syphilis in 2022 than in 2012. Routine screening and timely and adequate treatment of pregnant people for syphilis, ideally more than 30 days before delivery, can effectively prevent this condition in newborns. Due to increasing cases, the American College of Obstetricians and Gynecologists recently updated their guidance for obstetrician–gynecologists and other obstetric care professionals advising serological screening for all pregnant individuals at the first prenatal visit and universal screening at the third trimester and at birth. During the 2024 legislative session at least two states—Missouri (SB 1260) and Maryland (HB 119)—are considering legislation that would require testing during pregnancy care at the third trimester for syphilis. Maryland’s legislature passed HB 119, which would require screening at the third trimester and at birth, as well as requiring the hospital to determine the syphilis status of the birthing parent before discharging the newborn. In 2023, New York enacted legislation (A 3007) that requires syphilis screening in the third trimester, and in the current legislative session they are considering S 2472, which would allow the state health department to provide education about congenital syphilis and screenings. At least six states have considered and passed legislation during the 2024 legislative session regarding expanded access for HIV prophylaxis (PrEP) and post-exposure prophylaxis (PEP). Of those considered, Georgia enacted HB 1028 to allow PEP to be issued by a standing order; Florida’s legislature passed HB 159 that would allow pharmacists to screen for HIV exposure, order, and dispense prevention drugs PEP and PrEP and sent it to the governor. Similarly, in Delaware the Senate chamber passed SB 194 that would permit pharmacists to provide PrEP and PEP pursuant to an approved protocol. Family and Reproductive Health Policymakers across all levels of government continued taking steps to make it easier for people to access contraceptives. In 2023, at least 14 states enacted laws in 2023 to facilitate expanding access to contraceptive care by either expanding the ability for pharmacists to dispense birth control without an individualized prescription and/or allowing pharmacists to dispense up to 12 months of contraceptives at once. So far in 2024, at least 13 jurisdictions considered legislation allowing pharmacists to dispense contraceptives without a prescription and at least 18 states considered legislation supporting access to 12 month supply of contraceptives. Following FDA’s July 2023 approval of Opill—the first over-the-counter (OTC) birth control pill—the drug is currently available in stores with several major pharmacies and health plans announcing that they will provide the medication at zero cost for many health plan sponsors. To further support access to Opill, at least two states (New Mexico and Wisconsin) issued standing orders for Opill to facilitate Medicaid coverage of the medication. Additionally, Maryland’s legislature passed SB 527 in March 2024, which requires community colleges to develop and implement a plan to provide students access to OTC contraception. In February 2024, New York enacted S 8096 allowing the commissioner of health to issue a standing order allowing a pharmacist to dispense self-administered hormonal contraceptives, effective retroactively to January 1, 2024. Under the new law, New York’s Commissioner of Health issued a standing order to allow pharmacists to dispense up to 12 months of self-administered hormonal contraceptives like birth control pills, vaginal rings, and contraceptive patches. Optimal Health for All ASTHO anticipates policymakers will take steps to improve collection of health disparities data, address inequities rural communities face in accessing care, and to support climate change adaptation planning efforts. So far in the 2024 legislative session, several states are considering bills to improve health care access and outcomes in rural areas. California is considering legislation (SB 945) that would build an integrated data dashboard to provide the public with information on the health impacts caused by wildfires and the effectiveness of forest health and wildfire mitigation on health outcomes. Additionally, California (AB 2342) is looking to ensure critical access hospitals on remote islands receive adequate funding through a dedicated annual supplement. New York is considering at least two bills that would promote rural health care access. First, New York S 8582 would create a pilot program to identify rural health zones and convene a rural health zone board