Comment on DOS-2026-0694-0008

The requirement in DS-3026 to obtain laboratory results for Herpes Simplex Virus type 1 (HSV-1) and type 2 (HSV-2) by blood test warrants careful medical and legal justification because routine serologic screening for HSV is not generally recommended for asymptomatic individuals by major clinical authorities. HSV-1 and HSV-2 are common viral infections that establish lifelong latency following primary infection. Serologic testing detects antibodies indicating prior exposure but does not determine whether an individual has active disease, is currently infectious, or poses a present risk to others. A positive antibody test therefore reflects previous infection rather than current clinical status. Medical literature consistently recognizes important limitations of HSV serologic screening. Type-specific antibody tests have imperfect sensitivity and specificity, particularly in populations with a low prevalence of infection, resulting in false-positive and false-negative results. Moreover, there is no curative treatment that eradicates latent HSV infection. Antiviral medications such as acyclovir, valacyclovir, and famciclovir reduce the frequency and severity of symptomatic outbreaks and decrease viral shedding but do not eliminate the virus or permanently alter serologic status. Consequently, identifying asymptomatic individuals through routine antibody testing does not provide the same public health benefit as screening programs designed to detect curable or immediately controllable infectious diseases. For these reasons, major medical organizations do not recommend routine HSV serologic screening of asymptomatic adults in the general population. Concerns include the limited clinical utility of positive serologic results, the potential for false-positive diagnoses, psychological harm, social stigma, and the absence of evidence that population-based serologic screening improves health outcomes or substantially reduces transmission. The public health rationale for mandatory medical testing should be supported by evidence demonstrating that the test identifies a condition for which detection meaningfully protects the population. Unlike communicable diseases that require immediate diagnosis, isolation, treatment, or contact investigation to prevent widespread transmission, HSV infection is endemic worldwide, frequently asymptomatic, and managed primarily through individualized clinical care and patient counseling. Public health strategies emphasize education, symptom recognition, informed decision-making, and appropriate antiviral therapy for symptomatic individuals rather than universal serologic screening. From a legal perspective, compulsory medical testing should satisfy the principles of necessity, proportionality, medical necessity, and legitimate governmental purpose. These principles require that mandatory testing be reasonably necessary to achieve a clearly defined objective and that any intrusion upon bodily integrity and medical privacy be proportionate to the anticipated public benefit. Where scientific evidence does not demonstrate that routine HSV serologic screening of asymptomatic individuals materially advances public health objectives, the justification for mandatory testing becomes correspondingly weaker. The principle of data minimization, recognized in many privacy and data protection frameworks, similarly requires that only medical information necessary to accomplish the stated purpose be collected. If the objective of the examination is to identify conditions that pose a significant public health risk, the routine collection of HSV antibody results should be supported by evidence demonstrating that such information is necessary, effective, and proportionate to that objective. Accordingly, if DS-3026 requires routine HSV-1 and HSV-2 serologic testing for all applicants, the requirement should be accompanied by a clear scientific and legal justification explaining why it departs from the recommendations of major clinical organizations regarding asymptomatic HSV screening and how the testing materially advances the specific public health objectives of the examination.