Regular Session
Government Affairs & Regulatory Compliance Analysis
HB4535 mandates that all Texas healthcare providers administering COVID-19 vaccines must utilize a specific Department of State Health Services (DSHS) information sheet and obtain written informed consent acknowledging its receipt. Effective September 1, 2025, failure to adhere to this specific workflow constitutes grounds for disciplinary action against professional licenses (Medical, Nursing, Pharmacy).
Rep. John McQueeney·House Bill·Regular Session
Department of State Health Services • Other applicable healthcare licensing authorities • Texas Board of Nursing • Texas Medical Board • Texas State Board of Pharmacy
This legislation has regulatory implications for the following Texas businesses and organizations:
Significant regulatory changes (effective 2025-09-01). Review with your legal and compliance teams to understand implications.
Affected business types:
lowMinimal cost impact anticipated.
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JD Key Consulting provides strategic guidance on Texas regulatory compliance and legislative impact for your business.
Key implementation requirements and action items for compliance with this legislation
Master Services Agreements (MSAs) with third-party vaccination vendors (e.g., mobile clinics, corporate wellness providers) must be amended to mandate the use of the DSHS-compliant forms. Indemnification clauses should be updated to protect your facility if a vendor places your license at risk by failing to obtain the specific consent.
Clinical staff must undergo mandatory training to halt administration until the specific "receipt of information" acknowledgment is signed. Update employee handbooks to explicitly define failure to obtain this specific written consent as a violation of state law and grounds for termination, as it directly jeopardizes the facility's operating licenses.
Electronic Medical Records (EMR) systems must be updated to include the DSHS text and a distinct signature field for the statutory acknowledgment. A generic "Consent to Treat" is no longer legally sufficient for this procedure; records must prove the patient specifically acknowledged receipt of the Section 161.0086(c) information sheet.
There are no new state fees associated with this bill. Operational costs are limited to IT system updates (EMR reconfiguration) and printing physical copies of the DSHS information sheet.
JD Key Consulting specializes in Texas regulatory compliance strategy. Work directly with James Dickey—former Chairman of the Republican Party of Texas—to understand this bill's impact on your operations and develop an actionable compliance plan.
Schedule a ConsultationInformation presented is for general knowledge only and is provided without warranty, express or implied. Consult qualified government affairs professionals and legal counsel before making compliance decisions.
This bill's path through the Texas Legislature
Explore more bills from this author and on related topics
Common questions about HB4535
HB4535 mandates that all Texas healthcare providers administering COVID-19 vaccines must utilize a specific Department of State Health Services (DSHS) information sheet and obtain written informed consent acknowledging its receipt. Effective September 1, 2025, failure to adhere to this specific workflow constitutes grounds for disciplinary action against professional licenses (Medical, Nursing, Pharmacy).
HB4535 was authored by Texas Representative John McQueeney during the Regular Session.
HB4535 was signed into law by Governor Greg Abbott on June 20, 2025.
HB4535 is enforced by Department of State Health Services, Other applicable healthcare licensing authorities, Texas Board of Nursing, Texas Medical Board and Texas State Board of Pharmacy.
The regulatory priority for HB4535 is rated as "critical". Businesses and organizations should review the legislation to understand potential impacts.
The cost impact of HB4535 is estimated as "low". This may vary based on industry and implementation requirements.
HB4535 addresses topics including health care providers, health, health--other diseases & medical conditions, covid-19 and immunizations.
Key dates for HB4535: Effective date is 2025-09-01. Rulemaking: Develop and publish the standardized information sheet regarding vaccine risks, development speed, and liability. (2025-09-01 (Implied)). Consult with legal counsel regarding applicability.
HB4535 establishes the following penalties: administrative penalty of Disciplinary action (suspension, revocation, or administrative penalties per licensing board guidelines) for Administering a COVID-19 vaccine without obtaining written informed consent that acknowledges receipt of the DSHS information sheet.. Consult with legal counsel for specific applicability to your situation.
HB4535 primarily affects healthcare providers and medical facilities. These businesses should review the legislation with their legal and compliance teams to understand potential impacts.
JD Key Consulting is an Austin, Texas-based government affairs firm led by James Dickey, former Chairman of the Republican Party of Texas. We specialize in Texas regulatory compliance and legislative strategy for data centers, energy, banking, and manufacturing.
