The US Constitution acts as a brake on legislation and other state action that impinges on the procreative liberty of individual citizens. Procreative liberty is a negative right guaranteeing against governmental interference in the exercise of procreative aims but not guaranteeing any assistance toward the accomplishment of those aims. Although commentators often posit that restrictions on access to assisted reproduction raise ethical issues of procreative autonomy [8], whether procreative liberty subsumes resort to assisted reproduction as a legal matter remains an academic question. The federal courts have made only a very few discrete pronouncements on the matter [9, 10]. For example, a lower court has held that chorionic villi sampling within the first trimester of pregnancy, falls within the ambit of constitutionally protected procreative freedom, since it is designed to provide information relevant to keeping or terminating a pregnancy [10]. Because PGS and PGD provide information relevant to commencing a pregnancy, they, too, might fall within the protected ambit. Restrictions on them would therefore likely be constitutionally infirm, but a more solid prediction is difficult to make. The issue is, moreover, unlikely to arise with any frequency in a system where so little regulation exists.

For clinics engaged in embryo testing for IVF, the relevance of the Constitution’s guarantee of procreative liberty will become clearer if the issue of embryo testing ever reaches the US Supreme Court. The Court could easily draw a distinction between PGS, the aim of which is successful procreation, and PGD, whose aim is the selection of an offspring’s traits. The Court might be of the opinion that procreative liberty does not extend to PGD. Moreover, the Court might decide that the line should be drawn between embryo testing and prenatal testing, with the latter on the side of procreative liberty because it implicates a pregnant woman’s bodily integrity. A very conservative Court could well determine that neither prenatal testing nor embryo testing are exercises of procreative liberty.

Whether a clinic would ever have to defend itself against a patient’s claim of procreative liberty is doubtful. Most infertility clinics in the United States are private entities. Their activities thus do not constitute the state action that is a prerequisite for a valid constitutional claim. Where a clinic is an arm of the state, as where it is a unit within a public university, the Constitution does apply to its actions. But being a public facility in no way means that a clinic is bound to provide any particular service. The most viable constitutional claim in such a context would be one alleging class-based discrimination in the delivery of care. Even then, a clinic may escape liability if the targeted group is not one that receives the highest level of protection in the litigation of individual constitutional rights. At present, regulations that treat individuals differently based on matters of race and ethnicity receive the highest level of judicial scrutiny in constitutional rights cases. Discrimination against other groups, though, may be prohibited by statutes that apply to both public and private facilities (see section “Statutes and Administrative Regulations,” below).

For any legislation to be a proper exercise of governmental power, it must promote public health, safety, welfare, or morals and utilize means that are at least rationally related to those goals. To satisfy the Constitution, though, legislation must not be so vague as to leave unclear what conduct it prohibits. Infertility physicians in Illinois raised vagueness in their challenge of a prohibition on nontherapeutic fetal experimentation [10]. The court agreed that the statute failed to define “experimentation” and “therapeutic” and so left unclear whether it prohibited the physicians’ use of evolving prenatal diagnostic techniques. With respect to embryos, statutes in other states contain similar prohibitions on experimentation, but most of these appear to address research on embryos [11]. Since PGS and PGD for IVF are not research experiments and are perhaps routine enough not to be considered experimental [12], these statutes arguably do not apply to these techniques.

Statutes and administrative regulations are codified rules enacted by legislatures and the agencies to which they delegate rulemaking authority. At the federal level, Congress often delegates rulemaking power when special expertise is required to implement the provisions of a statute. Administrative agencies thus become “arms of Congress” and must act consistently with their statutory mandate.

Very little in either American statutes or administrative regulations bears directly on embryo testing for IVF. Nonetheless, there are several provisions of which clinicians should be aware. These provisions aim to promote privacy and safety in matters of genetic testing and to combat the discrimination that might occur were sensitive genetic information to fall into the wrong hands.

The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), divisions of the US Department of Health and Human Services, are tasked with protecting the United States from health, safety, and security threats and regulating biological products for human use, respectively. The CDC’s regulation of assisted reproduction lies in its implementation of the Fertility Clinic Success Rate and Certification Act. This statute requires clinics that provide IVF services to make annual reports of their success rates to the federal government. These reporting requirements do not include information about the use of or results achieved from PGD [13].

The FDA specifically regulates “human cells or tissues intended for implantation,” [14] a category that includes oocytes and semen. The FDA’s specific goals are “to ensure that donors do not harbor infections that could be transmitted to recipients” [15] and to minimize the risk of contamination in the handling of human tissues. The governing rules require establishments that handle human cells and tissue to register with the FDA and require screening and testing of tissue donors “for risk factors for, and clinical evidence of, relevant communicable disease agents or diseases” [16]. The necessary screening does not, however, require genetic testing of tissue donors (Anderson H., US FDA 2014, personal communication). The testing requirement also does not extend to “[r]eproductive cells or tissue donated by a sexual intimate partner of the recipient for reproductive use” [17]. The FDA sometimes inspects establishments for compliance with these rules. The FDA also regulates medical devices, such as products used to perform genetic tests [18]. Whether the FDA is competent to regulate the genetic testing techniques developed by genetics laboratories in-house has been the subject of debate in recent years. The FDA has, however, issued a set of nonbinding recommendations for the regulation of laboratory-developed genetic tests in some cases [19]. Once a medical device is approved by the FDA, the actual use of it by physicians does not fall within the purview of its regulatory authority.

The Clinical Laboratory Improvement Amendments (CLIA) aim to ensure the quality of laboratory testing through a certification program. The program is administered by the Centers for Medicare & Medicaid Services, another division of the US Department of Health and Human Services. The Amendments apply to laboratories that conduct assays on human bodily material in the course of medical treatment. Laboratories that conduct genetic testing must meet the basic criteria for labs performing high complexity tests generally. To enhance this oversight, the CDC has promulgated a set of good laboratory practices in molecular genetic testing for heritable diseases and conditions (good laboratory practices in biochemical genetic testing are the subject of a separate CDC publication). The practices address the qualifications of laboratory personnel, the testing process, and the privacy of patients’ information, among other things, but do not explicitly refer to the genetic testing of embryos for transfer [20].

At the state level, there is virtually no direct regulation of PGD, except for laboratory quality assurance programs requiring laboratories performing PGD to acquire a permit [21–23]. Under New York’s Clinical Laboratory Evaluation Program, which regulates laboratories performing PGD on specimens originating in New York, a laboratory must “obtain the subject’s informed consent and include in their reports a statement of and an interpretation of its findings, the test’s technical limitations, suggestions for additional testing, recommendations for referral to a genetic counselor (if applicable), the test methodology, and a list of all variants examined in the assay” [24]. Although a waiver procedure is available, New York’s permit requirement has produced anxiety among clinics that the limited number of permitted labs capable of providing specialized assessment of embryos and the tight turnaround time required for IVF will impact negatively on patients [25]. Currently 18 laboratories in New York State and 59 outside of New York have permits to perform molecular genetic testing. Not all of these laboratories, though, offer PGD.

Genetic counseling has also been of interest to state regulators in recent years. Several states require genetic counselors to be licensed, often in conjunction with the certification programs established by the American Board of Genetic Counseling or the American Board of Medical Genetics [26]. These licensing schemes do not in all cases apply to licensed physicians who provide genetic counseling [27] but also may not permit physicians to call themselves genetic counselors without procuring a license [28].

The Health Insurance Portability and Accountability Act (HIPAA) provides minimum standards for ensuring the confidentiality of patients’ health-care information. Under HIPAA, laboratories that conduct molecular genetic testing must take steps to “ensure the confidentiality of patient information, including molecular testing information and test results” [29]. Some states have similar privacy laws that explicitly apply to genetic testing and define genetic information as protected health information [30] or as the property of the individual to whom the genetic information relates [31]. These laws limit the ways in which health professionals may use what they uncover in the course of examining embryos destined for IVF. Civil and criminal liability attaches to the violation of genetic privacy laws [32].

Finally, discrimination in matters of genetic testing is forbidden by statute. The federal Genetic Information Nondiscrimination Act (GINA) [33] and analogous state laws prohibit health insurance carriers and employers from discriminating against individuals based on their genetic information. The drafters of GINA were concerned that discrimination could occur against healthy individuals based solely on their genetic predisposition toward certain diseases. The statute’s implementing regulations explicitly include preimplantation genetic diagnosis on embryos created using IVF within the definition of a genetic test [34], and “[g]enetic information” includes “genetic information of any embryo… ” [35].