U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.

In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product's widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.

Physician Speech and Firearm Safety: Wollschlaeger v Governor, Florida.

To provide the highest-quality medical care, physicians must be able to communicate openly with their patients and provide advice in conformance with professional standards of care. Although states have the power to regulate many aspects of medical practice, laws that interfere with speech by preventing physicians from discussing specific subjects with patients are constitutionally suspect. In 2017, the US Court of Appeals for the Eleventh Circuit struck down key provisions of a Florida law that prohibited physicians from speaking with their patients about firearm safety as a violation of the First Amendment. We discuss this case, Wollschlaeger v Governor, Florida, and the implications of the ruling. Although courts may rule that physician "gag laws," such as the one in Florida, are unconstitutional, this area of the law remains unsettled. Legislative mandates that interfere with medical practice may decrease the quality of care by substituting politics and legislative judgment for medical expertise.

Peridomestic Aedes malayensis and Aedes albopictus are capable vectors of arboviruses in cities.

BACKGROUND: Dengue and chikungunya are global re-emerging mosquito-borne diseases. In Singapore, sustained vector control coupled with household improvements reduced domestic mosquito populations for the past 45 years, particularly the primary vector Aedes aegypti. However, while disease incidence was low for the first 30 years following vector control implementation, outbreaks have re-emerged in the past 15 years. Epidemiological observations point to the importance of peridomestic infection in areas not targeted by control programs. We investigated the role of vectors in peri-domestic areas. METHODS: We carried out entomological surveys to identify the Aedes species present in vegetated sites in highly populated areas and determine whether mosquitoes were present in open-air areas frequented by people. We compared vector competence of Aedes albopictus and Aedes malayensis with Ae. aegypti after oral infection with sympatric dengue serotype 2 and chikungunya viruses. Mosquito saliva was tested for the presence of infectious virus particles as a surrogate for transmission following oral infection. RESULTS: We identified Aedes albopictus and Aedes malayensis throughout Singapore and quantified their presence in forested and opened grassy areas. Both Ae. albopictus and Ae. malayensis can occupy sylvatic niches and were highly susceptible to both arboviruses. A majority of saliva of infected Ae. malayensis contained infectious particles for both viruses. CONCLUSIONS: Our study reveals the prevalence of competent vectors in peri-domestic areas, including Ae. malayensis for which we established the vector status. Epidemics can be driven by infection foci, which are epidemiologically enhanced in the context of low herd immunity, selective pressure on arbovirus transmission and the presence of infectious asymptomatic persons, all these conditions being present in Singapore. Learning from Singapore's vector control success that reduced domestic vector populations, but has not sustainably reduced arboviral incidence, we suggest including peri-domestic vectors in the scope of vector management.

Advancing human rights in patient care of Roma: access to health insurance in Macedonia.

Roma in Macedonia suffer from dire health consequences due to economic factors, such as high rates of unemployment and poverty, and social factors, including discrimination by medical providers. Although Macedonia administers a public health care system for its citizens, Roma frequently lack access to this system in contravention of the rights to health and equality enshrined in Macedonia's Constitution and international law. Applying a human rights in patient care (HRPC) framework to this problem, we discuss a facially neutral law that predicated access to health insurance for low-income citizens on the submission of a statement of income. This requirement created additional barriers to care, which we describe in this article. Even after the Constitutional Court declared the requirement invalid, the government failed to implement appropriate changes to the law in a timely manner. We argue this failure threatened the rule of law in the country and further marginalized and discriminated against Roma in violation of their human rights.