Regulatory responses to medical machine learning.

Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and Europe. We then examine international perspectives and broader implications, discussing considerations such as data privacy, exportation, explanation, training set bias, contextual bias, and trade secrecy.

Sperm donor anonymity and compensation: an experiment with American sperm donors.

Most sperm donation that occurs in the USA proceeds through anonymous donation. While some clinics make the identity of the sperm donor available to a donor-conceived child at age 18 as part of 'open identification' or 'identity release programs,' no US law requires clinics to do so, and the majority of individuals do not use these programs. By contrast, in many parts of the world, there have been significant legislative initiatives requiring that sperm donor identities be made available to children after a certain age (typically when the child turns 18). One major concern with prohibiting anonymous sperm donation has been that the number of willing sperm donors will decrease leading to shortages, as have been experienced in some of the countries that have prohibited sperm donor anonymity. One possible solution, suggested by prior work, would be to pay current anonymous sperm donors more per donation to continue to donate when their anonymity is removed. Using a unique sample of current anonymous and open identity sperm donors from a large sperm bank in the USA, we test that approach. As far as we know, this is the first attempt to examine what would happen if the USA adopted a prohibition on anonymous sperm donation that used the most ecologically valid population, current sperm donors. We find that 29% of current anonymous sperm donors in the sample would refuse to donate if the law changed such that they were required to put their names in a registry available to donor-conceived children at age 18. When we look at the remaining sperm donors who would be willing to participate, we find that they would demand an additional $60 per donation (using our preferred specification). We also discuss the ramifications for the industry.

Circumvention tourism.

Under what circumstances should a citizen be able to avoid the penalties set by the citizen's home country's criminal law by going abroad to engage in the same activity where it is not criminally prohibited? Should we view the ability to engage in prohibited activities by traveling outside of the nation state as a way of accommodating cultural or political differences within our polity? These are general questions regarding the power and theory of extraterritorial application of domestic criminal law. In this Article, I examine the issues through a close exploration of one setting that urgently presents them: medical tourism. Medical tourism is a term used to describe the travel of patients who are citizens and residents of one country, the "home country," to another country, the "destination country," for medical treatment. This Article is the first to comprehensively examine a subcategory of medical tourism that I call "circumvention tourism," which involves patients who travel abroad for services that are legal in the patient's destination country but illegal in the patient's home country--that is, travel to circumvent domestic prohibitions on accessing certain medical services. The four examples of this phenomenon that I dwell on are circumvention medical tourism for female genital cutting (FGC), abortion, reproductive technology usage, and assisted suicide. I will briefly discuss the "can" question: assuming that a domestic prohibition on access to one of these services is lawful, as a matter of international law, is the home country forbidden, permitted, or mandated to extend its existing criminal prohibition extraterritorially to home country citizens who travel abroad to circumvent the home country's prohibition? Most of the Article, though, is devoted to the "ought" question: assuming that the domestic prohibition is viewed as normatively well-grounded, under what circumstances should the home country extend its existing criminal prohibition extraterritorially to its citizens who travel abroad to circumvent the prohibition? I show that, contrary to much of current practice, in most instances, home countries should seek to extend extraterritorially their criminal prohibitions on FGC, abortion, assisted suicide, and, to a lesser extent, reproductive technology use to their citizens who travel abroad to circumvent the prohibition. I also discuss the ways in which my analysis of these prohibitions can serve as scaffolding for a more general theory of circumvention tourism.

Release of the lipid peroxidation marker 8-epi-prostaglandin F2 alpha from isolated gill pavement cells.

The aim of the present study was to evaluate oxidative injury in gill pavement cells (GPCs) from fathead minnow (Pimephales promelas) using F2-isoprostane (F2-iP) release as an index of lipid peroxidation. Cells were isolated from pooled gill tissue by collagenase treatment, mechanical sieving, and Percoll density gradient centrifugation. Baseline levels of 8-epi-prostaglandin F2 alpha (8-epi-PGF2 alpha) were measured by incubating GPCs in physiological buffer (10(6) cells/ml) and enzyme immunoassay. After 60 min, the amount of immunoreactive 8-epi-PGF2 alpha (ir8-epi-PGF2 alpha) in control medium ranged from 1,374 to 5,515 pg/ml. Lead nitrate, 0.6 to 120 microM, did not influence ir8-epi-PGF2 alpha release, whereas FeCl3 stimulated release at 500 microM but not at 5 microM. Incubation medium was extracted for acidic lipids and analyzed by liquid chromatography/mass spectrometry/electrospray ionization. A compound in the medium exhibited a retention time on reverse-phase high-performance liquid chromatography nearly identical to that of synthetic 8-epi-PGF2 alpha The mass spectrum taken from the total ion chromatogram from 14.8 to 15.1 min contained a prominent ion at m/z 353, as expected for the molecular ion of 8-epi-PGF2 alpha. Similar results were obtained with tissue subjected to base hydrolysis. Mass spectra of extracted ion chromatograms obtained with gill extracts and authentic standard showed a close correspondence of fragment ions, providing definitive evidence for production and storage of F2-iPs by fish gills. In summary, F2-iP release occurs during lipid peroxidation injury to fish gill epithelium, and its measurement may facilitate aquatic toxicology studies of metallic and nonmetallic contaminants.

Treatment of Madelung's deformity in adults by ulna reduction osteotomy.

PURPOSE: Adult patients with Madelung's deformity may present with ulnar-sided wrist pain. Treatment often involves addressing the distal radial deformity. If there is focal wrist pathology and a positive ulnar variance, however, then an isolated ulnar-shortening osteotomy may provide symptomatic relief in these patients. The purpose of this study was to report our results of ulnar-shortening osteotomy without radial osteotomy in adult patients with Madulung's deformity. METHODS: From 1988 to 2001 9 wrists in 9 adult patients with Madelung's deformity and ulnar-sided wrist pain underwent ulnar-shortening osteotomy. The distal radius abnormality was not addressed. All of the patients were women and the average age at the time of surgery was 34 years (range, 29-45 y). Two of the individuals were mesomelic dwarfs and the remaining 7 patients were otherwise normal. Surgery was performed after the patients failed at least 6 months of nonsurgical management. RESULTS: All patients had improvement of their symptoms at an average follow-up evaluation of 42 months (range, 6-112 mo). All of the osteotomies united. One patient required replating for a delayed union. There were no infections and no ulnar carpal subluxation. Ulnar-positive variance correction averaged 4.4 mm. Postoperative range of motion and grip strength were equivalent to the contralateral wrist. CONCLUSIONS: Ulnar-shortening osteotomy is a safe and reliable surgical procedure that can relieve ulnar-sided wrist pain in adult patients with symptomatic Madelung's deformity and positive ulnar variance.

New onset diabetes mellitus in patients presenting with extremity infections.

Although a relationship between diabetes and extremity infections has been established, the current literature notes little regarding the initial diagnosis of a patient's diabetic condition being made at the time of presentation with an extremity infection. The current study is an analysis of patients with extremity infections being diagnosed with diabetes for the first time. A chart review of 1166 patients who were admitted to the orthopaedic infection service revealed 385 patients with an admission glucose of 120 mg/dL or greater. One hundred seventy-four of these patients (45%) were diagnosed with diabetes. Thirty of these 174 patients (17.2%) previously had not been diagnosed with diabetes.