Is it illegal for a consumer to obtain or use a non-FDA approved medical device? The Freestyle Libre Pro, which is a continuous glucose monitoring (CGM) system, was approved in September 2016 for use by healthcare professionals has not yet been approved for use by consumers, as described in this press release: ABBOTT RECEIVES FDA APPROVAL FOR THE FREESTYLE LIBRE PRO™ SYSTEM, A REVOLUTIONARY DIABETES SENSING TECHNOLOGY FOR HEALTHCARE PROFESSIONALS TO USE WITH THEIR PATIENTS Freestyle Libre Pro is a continuous glucose monitoring (CGM) system designed to provide a clear, visual snapshot of a patient's glucose levels, trends and patterns for up to 14 days Requires no fingersticks to calibrate the system -- an advantage over other professional use CGM devices Significantly lower cost than other professional CGM systems Consumer version of the technology, FreeStyle Libre™, is currently under review by the U.S. Food and Drug Administration What that means is that doctors can give the system to their patients so they can monitor the patients' blood glucose levels, but patients can't just buy it on their own to monitor their own blood glucose levels. My question is, would it be illegal for a patient to obtain the Free Style Libre Pro on their own and to use it to monitor their own blood glucose levels? Is it only manufacturers, distributors, and doctors who are bound by the FDA regulations, or would consumers face criminal or civil penalties if they use it without FDA approval?
The FDA approved the device as requiring a prescription (not OTC). FDA regulations govern the manufacture or distribution of devices and drugs, not the consumption. An overview of FDA regulation is here. They say they they are "responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States". The entire pile of regulations (21 CFR) is here. There has to be an underlying statute that authorizes the FDA to impose restrictions: that would be in Title 21 of the US Code. The specific law regulating medical devices is 21 USC 360. Congress can easily pass laws that restrict what businesses do (a consequence of the Commerce Clause of the Constitution), but they (theoretically) have a more limited ability to restrict what an individual does. Since there is no federal law prohibiting the use of a prescription device, it is not a crime to possess or use such a device.
First of all, even if it is not allowed to test them, you can also refuse to service someone untested - and that is not illegal discrimination, as &quot;untested for COVID 19&quot; is not a protected class. Public Schools however are not companies in the normal way, and the CDC can only advise in the rulemaking of local legislators and executives. And in the current health crisis, the school board and health authorities can order things for the protection of others and this can be enough justification to exclude individuals or several people from groups. After all, being teste or not is clearly not a protected class under the Civil Rights Act, and neither is easily regarded as a form of first amendment speech - unlike a black armband (Tinker v. Des Moines Independent Community). Being untested is much more akin to being a person on a ship and then attempting to disembark in a quarantine zone - which was decided in Compagnie Francaise &amp; Lousiana Board of Health (there are two of those btw). The majority opinion in the SCOTUS case (1902) writes (emphasis mine): 24 True it is that, in some of the cases relied on in the argument, it was held that a state law absolutely prohibiting the introduction, under all circumstances, of objects actually affected with [a contagious] disease, was valid because such objects were not legitimate commerce. But this implies no limitation on the power to regulate by health laws the subjects of legitimate commerce. 34 [A]ssuming that all the treaties relied on are applicable, we think it clearly results from their context that they were not intended to, and did not, deprive the government of the United States of those powers necessarily inhering in it and essential to the health and safety of its people. Using a similar vein as in Compagnie Francaise, the public health interest might be enough for even a public school to only allow presence in the building with a test and otherwise demand online or remote learning (which isn't always an option) or even just suspend people that are not tested until such a time their presence is deemed safe. A private school is vastly more free in rulemaking, and as even a public school can muster strict scrutiny regarding presence teaching, a private school surely will get away with it. But nothing can force a private school to suspend teaching, switching to online classes or demand to test, unless they like to or their accreditation hinges on it - and here religious schools come in: There are religious groups that to an extent of not allowing medical procedures on their members, including COVID-testing. Those schools could ban people from attending that are tested. Endnote Public Health Interest is a hammer that can be rather heavy. It can't be used to discriminate against HIV, as that doesn't spread from touch and sneeze, but it can be used to ban people from buildings that have Communicable Diseases. While nobody classed COVID 19 as such yet, having such an illness [Plague, Cholera, Botulism, and others] allows the government to isolate you under strict scrutiny or even has been used to quarantine whole areas in the past (see the Compagnie Francaise case). And as you see in the current pandemic, legislative bodies globally do dish out rules for schools and public places in short order, some of which include testing strategies, and ways to overwrite consent via a state order. Some are struck down: some of them on procedural grounds (e.g. wrong body), others on grounds of equality (e.g. religious bias).
There are regulations governing occupational safety, whereby e.g. an employer can be fined for forcing employees to work in a literally toxic environment, for instance breathing chlorine gas. You could file a complaint with a state or federal agency (OSHA). You would need to hire a labor lawyer to get advice about your specific circumstance, to see if there is indeed a provision that covers what you describe, though I doubt it would. OSHA's blurb on disease don't obviously cover your situation (they describe situations that govern healthcare workers in intimate contact with infectious materials). However, certain diseases such as TB or Ebola cause a general health quarantine to be imposed, so if a worker comes in with such a disease, action would be taken by the health department. This does not cover sniffles, and probably not pertussis (but that's a local decision). There are also regulations pertaining to disabled employees, whereby an employee who is disabled by having a severely compromised immune system can be entitled to reasonable accommodation, for example allowed to work in a closed room away from others (if the job is not a receptionist job). That entitlement only applies to the employee, and is controlled by objective health danger (requires a doctor's note), and not the comfort level of the employee.
Generally, such sanctions prevent certain sorts of transactions in goods and services with nationals or entities of the nation under sanction. The exact list of transactions prohibited or restricted varies. If Open source software were being provided as a service, so that the recipient paid directly for a license, or for customization or configuration work, or for some sort of consulting or assistance, such transactions could be banned or restricted by a sanctions regime, but might not be. (If the sanctions included that particular class of transactions.) However, if it is merely a matter of an open source product being published, for anyone to download, install, and use, I don't see how that would be barred or restricted by any sanctions of the sort recently in use.
The official clause in question is here: Pecandu Narkotika yang telah cukup umur sebagaimana dimaksud dalam Pasal 55 ayat (2) yang sedang menjalani rehabilitasi medis 2 (dua) kali masa perawatan dokter di rumah sakit dan/atau lembaga rehabilitasi medis yang ditunjuk oleh pemerintah tidak dituntut pidana which unofficially says Narcotics addicts who are old enough as referred to in Article 55 paragraph (2) who are undergoing medical rehabilitation with at least two treatments by doctors in hospitals and / or medical rehabilitation institutions designated by the government shall not be not criminally prosecuted where the italicized part involves some interpolation – a professional legal translator could have a better English rendition. The point is that you have to actually be getting treatment, and it has to be at a facility that is approved (ditunjuk) by the government. Such addicts are not criminally "dituntut", which could cover being charged, indicted, prosecuted or sued, a minor ambiguity resolved by the fact that the prosecutor is the "penuntut umum" (same root word). Under the law, it is not sufficient to just register (report yourself), you have to actually be receiving treatment. The part about "was not sentenced" is just a mistake.
The purpose of the button is not to put liability on you, but to shield the website from liability. The website does not want you looking up information about drugs, deciding that a particular drug is right for you, causing yourself harm and then blaming the website. You may have acted unlawfully but you would have no liability because no injury (financial or otherwise) has been caused to the website. Clicking the button is an assertion that one is a medical professional. This is a false statement, so the website could sue you for the tort of deceit, but there is no injury, which is one of the elements of deceit. The website would not even get nominal damages. The button may also constitute a contract. In exchange for access to a website, you warrant that you are a medical professional. You are not, which is a breach of the contract. However, the damages are nil. Conceivably, if you passed the information on to someone else who misused it, there may be some injury to the website, and then you would have to compensate the website for that injury under one or both of the heads of liability described above. In terms of criminal liability, it is rarely an offence to make a false statement to a private body without some other aggravating element. For example, in Australia, it is an offence to make a false statement for financial gain, or to make a false statement to a government official (regardless of whether there is financial gain etc). But simply making a false statement is not by itself a crime. You may breach a computer law. The United States Computer Fraud and Abuse Act is pretty broad. Obtaining information from a computer without authority is an offence: 18 USC s 1030(a)(2)(C). The only exception is if the web server is in the same state as you and somehow nobody from outside the state can access it: see definition of 'protected computer' in 18 USC s 1030(e)(2).
The regulations known as HIPAA are here. A good place to start is with who the regulations apply to. §160.10 lays that out: a health plan, health care clearinghouse, care provider, their business associates, and the Inspector General. Family members are not regulated entities. Subpart E regulates individually identifiable health information (such as "person X has condition Y") – this is protected information. §164.502 states that A covered entity or business associate may not use or disclose protected health information except as permitted or required by this subpart or by subpart C of part 160 of this subchapter. The first permitted use / disclosure is that the information may be revealed to the individual (the individual). Under 164.502(a)(2)(1) they are required to reveal information to an individual "when requested under, and required by §164.524 or §164.528" (you have a right to see your own record; you have a right to know who knows). 164.502(g) requires the covered entity to treat the "Personal Representative" as the same as the individual, and then there is a list of conditions surrounding being a personal representative, reducing to being empowered under law to act on behalf of the individual in making health decisions (it gets complicated in dealing with minors). 164.510 covers disclosure in emergencies, and under (b)(2) allows disclosure to a family member with advance consent of the individual. And so on. There is no general rule "and the covered entity may / must reveal private information to an interested individual", even a spouse, without consent of the individual. In other words, the doctor has an obligation to not disclose this information, unless permitted by the individual.
The issue is more likely that there is no law or regulation allowing the use of dogs to sniff passengers in the US for matters not related to crime, whereas Dubai, a monarchy, has a different political system. In general, you have the constitutional right to move about in the U and the right not to be unreasonably seized, a right which may not exist in some other jurisdictions. That right can be restricted in accordance with law, but there has to be some such law. It is not a crime to have covid, or to travel while infected (it is a crime to carry bombs and drugs on a plane). One area where there is some restriction is where there always has been a restriction, namely entry into the US. There is (was) covid screening at certain airports for flights from certain countries. This directive indicates the airport restrictions, but does not explain what screening will take place. The above DHS site says that &quot;the passenger will be asked about their medical history, current condition, and asked for contact information for local health authorities. Passengers will then be given written guidance about COVID-19 and directed to their final destination, and immediately home-quarantine in accordance with CDC best practices&quot;. It is not clear whether a mandatory temperature check without even reasonable suspicion of a crime would constitute an unreasonable search (body searches are subject to higher standards than property searches, it seems), and constitutional law surrounding searches has emphasized the primacy of privacy in search law, not the fact of physically entering property of the body. Some airlines and airports offer voluntary temperature checking, so it might be possible if someone has a covid-sniffing dog to offer voluntary sniff testing, especially if it is offered by a private concern and does not have the appearance of government mandate (which would require a law).