Establishing a Strong Quantitative Medicine Innovation Network
Comment: Submitted to the Food and Drug Administration
Policy

In August 2026, LDI Senior Fellow Cheryl Bettigole, MD, MPH submitted a comment to the Pennsylvania Department of Health in response to a proposed regulation to expand the list of reportable diseases, infections, and conditions to address changing standards and recommendations from experts.
Her comments address concerns about adding moral and ethical grounds upon which a parent or guardian may object to a child being vaccinated and provide support for amendments in the proposed regulations including
Views expressed by the researchers are their own and do not necessarily represent those of the University of Pennsylvania Health System (Penn Medicine) or the University of Pennsylvania.
August 27, 2026
Comments re: Proposed amendments to 28 Pa. Code Chapter 27
Attention: Theresa Kash and Melissa Myers, Pennsylvania Department of Health
Good afternoon Ms. Kash and Ms. Myers,
I am writing to submit the following comments on the proposed amendments to 28 Pa. Code Chapter 27. I am submitting these comments as an individual faculty member at the University of Pennsylvania Perelman School of Medicine and do not speak for the university or the medical school.
The proposed amendments to existing regulations at 28 Pa. Code Chapter 27 are needed to expand the list of reportable diseases, infections and conditions, to address changing standards and recommendations from experts, such as the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP), and to ensure the overall public health and safety by reducing the risk and spread of diseases, infections and conditions.
For example, the amendments add exclusion requirements from daycare and from school for children with infectious diarrhea, including diarrhea caused by campylobacter, clostridium difficile, norovirus, rotovirus, and other forms of infectious diarrhea when their diarrheal stools cannot be contained in a diaper. They also exclude toilet-trained individuals from school and childcare group settings if the individuals’ campylobacter-associated, norovirus-associated, or other infectious forms of diarrhea are causing uncontrolled bowel movements. These new exclusions are important common-sense measures that will help to prevent spread of these potentially dangerous conditions. Adding polio to the list of infections for which individuals should be excluded is a sad necessity now that the US has seen its first case of paralytic polio in a decade.
The amendments also update reporting requirements for some types of infections that could put the public at risk (e.g. salmonella) from 5 days to 24 hours, allowing for more rapid response to potential outbreaks. They add new conditions, many of them unknown at the time the original regulation was written, including babesiosis, chikungunya, cyclosporiasis, dengue, Marburg, and Powassan, for which reporting can help to expand our understanding and our ability to control these newly recognized pathogens.
The amendments also make reporting of vaccines to the state’s immunization system mandatory for health care providers, unless the patient opts out (with an exception for Philadelphia to avoid duplication). This requirement will make the state immunization system more complete, making it easier for health care providers to advise patients about which vaccines they may still need, and making it easier for state residents to obtain their own immunization records without having to contact multiple health care institutions. By including an opt out, the amendment recognizes that some state residents may not want their information included but provides a more functional system for those who do want to participate.
The birth defects registry created by the amendments will provide important data to guide public health efforts, and the requirements for testing of all pregnant individuals for syphilis in the 3rd trimester unless they opt out could help to stem the rising rate of congenital syphilis. Requirements for HIV and hepatitis C testing in early prenatal care for those who do not opt out offer the opportunity to treat these conditions to prevent transmission of these infections to the newborn.
The addition of “prevention, containment or mitigation” as justifications for the implementation of all disease control measures available to the Department under the Disease Prevention and Control Law allows the department authority for measures beyond isolation and quarantine to mitigate a future public health emergency. Depending on the type of public health emergencies we face in the future, isolation and quarantine may or may not be sufficient to protect state residents, so adding additional language here is an important safeguard.
The only area in which I would disagree with the proposed amendment is the proposal to add “or on the basis of a strong moral objection or ethical conviction similar to a religious belief” to the grounds upon which a parent or guardian may object to a child being vaccinated. Given our falling immunization rates nationally, loosening requirements for childhood vaccinations is likely to result in rising rates of vaccine-preventable disease, morbidity, and mortality.
Despite this last concern, these amendments represent well-thought-through measures to protect the health of state residents. Many thanks for this thoughtful effort.

Cheryl Bettigole, MD, MPH
Executive Director
Penn Center for Public Health
Comment: Submitted to the Food and Drug Administration
Comment: Delivered to the Office of Management and Budget
Testimony: Delivered to Philadelphia City Council’s Committee on Public Health and Human Services by Amy Hillier
Testimony: Delivered to Philadelphia City Council’s Committee on Public Health and Human Services by Aaron Richterman
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Comment: Submitted to the U.S. Food and Drug Administration (FDA)