HB 4535 proposes the establishment of requirements for administering COVID-19 vaccinations in Texas. The bill mandates that healthcare providers obtain written informed consent from individuals before administering a COVID-19 vaccine. If the individual is a minor or lacks mental capacity, the consent must come from a parent, guardian, or conservator.
The Texas Department of State Health Services (DSHS) must create a standardized information sheet that healthcare providers will give to patients before vaccination. This sheet will include details on:
- Risks and potential side effects associated with the vaccine.
- The expedited development process of the COVID-19 vaccine.
- The status of long-term scientific studies related to the vaccine.
- Civil liability status of vaccine manufacturers for vaccine-related injuries.
- The federal Vaccine Adverse Event Reporting System (VAERS), including how to report adverse reactions.
Healthcare providers who do not comply with these requirements may face disciplinary action from the appropriate licensing authority. The bill would take effect on September 1, 2025.
The original version of HB 4535 and the committee substitute both aim to regulate the administration of COVID-19 vaccines in Texas, focusing on informed consent and patient safety. Both versions mandate that healthcare providers obtain written informed consent from individuals before administering a COVID-19 vaccine. In cases where the individual is a minor or lacks mental capacity, the consent must come from a parent, guardian, or conservator. Despite their similar goals, the original bill and the committee substitute differ in a few key aspects.
One primary difference is how they assign responsibility for developing the standardized information sheet. In the original bill, the Texas Department of State Health Services (DSHS) is explicitly tasked with this duty, while the committee substitute uses the more general term "the department." This change allows for potential flexibility in determining which agency will handle the task, possibly reflecting input from stakeholders who raised concerns about administrative capacity or jurisdiction.
Another difference lies in how the bills address the issue of vaccine manufacturer liability. The original bill explicitly addresses whether manufacturers can be held civilly liable for injuries caused by the vaccine, emphasizing transparency regarding potential legal recourse. While the committee substitute retains this focus, it may adjust the language to be more nuanced or legally precise, addressing concerns that emerged during committee deliberations.
Finally, the original bill's language concerning disciplinary actions against healthcare providers who violate the informed consent requirements is more detailed, specifying that penalties should align with those for other regulatory infractions. In contrast, the committee substitute appears to streamline this section, likely aiming to reduce ambiguity and align more closely with existing healthcare regulation frameworks. This revision may make enforcement clearer and more consistent.
In summary, while the core intent of both the original bill and the committee substitute remains consistent—protecting individual rights through informed consent—the committee substitute introduces adjustments to clarify responsibilities, refine liability language, and streamline enforcement provisions. These changes likely reflect feedback from legislative discussions and stakeholder input, aiming to enhance the bill's practicality and coherence.