Why does the FDA prevent the sale of health reports that may affect a diagnosis or treatment plan to consumers? So I was reading an interesting article from MSN how a company can now map your genome for a relatively small fee. It mentions something confusing, that being that [...] the FDA restricts direct sales of health reports to consumers that have the potential to diagnose or change a course of treatment — information considered actionable [...] Why would the FDA limit actionable material that may enhance treatment? I'm certain it's probably inbetween the lines of the linked article, but I don't understand why such information would not be made available to consumers.
Why would the FDA limit actionable material that may enhance treatment? Because the FDA has a bunch of regulations that say if you are going to sell a medical test you first have to prove that it is safe, accurate, and effective. The genome scan companies first had to prove that their genome scans were accurate and had sufficient quality controls built in. In addition, the typical results from a genome scan involve a lot of ambiguity, and probabilistic measurements of relative risk, so there was a huge question of whether the automated reports produced by these companies would actually be accurate, intelligible, and not promise too much or too little to the consumer. The company, Sure Genomics, in the article you linked too, apparently avoids this issue by having a physician review the report, and consult with the consumer. Other companies tried to completely automate the process and didn't include the physician consultation. As least one company, 23andMe, has, at least partially, worked out it's issues with the FDA and can provide medical reports on some conditions.
The COVID restrictions are new enough that there are few court decisions on how to interpret them. There are frequent requests for court injunctions seeking temporary relief. Some pass, some are denied. The website might accuse locations listed there of breaking the restrictions. Making such an accusation in public sounds like a very bad idea, especially if there is no solid documentation. But the aggrieved party would be any location falsely listed. The site may or may not be hosted in Germany. If it is not, it becomes a really interesting question which law applies. You might inform the authorities, but beyond that, forget it.
It’s legal The regulations provide limits on various bacteria. If the product is made from raw milk, the manufacturer must implement a testing regime for those bacteria. If it’s made from treated milk, they avoid this cost.
There is a potentially infinite regress of questions regarding the constitutionality of restrictions imposed under these "emergency" circumstances. The basic legal principle is clearly established: laws restricting fundamental rights are subject to strict scrutiny. The specific details of a particular law and surrounding circumstances have yet to be discovered by the courts. If it is necessary to the purpose of saving lives that meetings of more than 10 people be prohibited, then the "compelling interest" test probably has been satisfied. That is basically a medical question, and the courts have a limited interest in scientific controversies, instead they are interested in whether people who make legal decisions do so rationally (is it reasonable to think that such limits would accomplish that compelling government end). Is it reasonable to think that restrictions lasting two months are necessary? The Black Death lasted at least 4 years. In the current circumstances (very limited hard knowledge this disease), it's hard to say what government actions could not be excused based on necessity. Summary execution is, at least in the current knowledge context, probably not going to pass strict scrutiny. As already explained in other thread on the topic, there is no "churches are above the law" constitutional provision. The appropriate question in the Florida case is not about the First Amendment, it is about the Due Process clauses – is the arrest lawful? We will, no doubt, see. On the face of it, he violated the law, so he can be arrested. I understand that there is a team poking holes in the order.
I make a copy of any important receipt printed on thermal paper, since the terms of many sellers and manufacturers require receipts for disputes. But I'm not aware of any law that says they have to make it convenient to maintain a receipt or other proof of purchase. However, when a company makes their terms unclear, unexpected, or difficult to comply with it seems there is often a lawyer ready to step up and file a class action lawsuit. Here's one archive to give you an idea of what companies will settle. In the United States the FTC is also empowered by law to "protect consumers," which means that if "disappearing" receipts become a widespread problem for consumers they could take action on the government's authority: The Federal Trade Commission Act is the primary statute of the Commission. Under this Act, the Commission is empowered, among other things, to (a) prevent unfair methods of competition, and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress and other relief for conduct injurious to consumers; (c) prescribe trade regulation rules defining with specificity acts or practices that are unfair or deceptive, and establishing requirements designed to prevent such acts or practices; (d) conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce; and (e) make reports and legislative recommendations to Congress. Given the above, I wouldn't be surprised to see either a class-action lawsuit or FTC rule that requires retailers to provide "durable" receipts, or some convenient substitute.
I only address the core legal question. The first question regards where the review appeared: on the facility's own web page, or on some third party web page? In the latter case, there is the possibility that soliciting a modified review in exchange for something of value violates the terms of usage for that web site. There are also US federal regulations pertaining to advertising, as well as state regulations. The federal regulations are here. The main question is whether what you say constitutes an endorsement, as specified here. They define an endorsement as: any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertiser, even if the views expressed by that party are identical to those of the sponsoring advertiser. The regulation in fact gives some helpful examples (reading them helps to clarify what an "endorsement" is), the last of which involves a dog: Example 8: A consumer who regularly purchases a particular brand of dog food decides one day to purchase a new, more expensive brand made by the same manufacturer. She writes in her personal blog that the change in diet has made her dog's fur noticeably softer and shinier, and that in her opinion, the new food definitely is worth the extra money. This posting would not be deemed an endorsement under the Guides. Assume now that the consumer joins a network marketing program under which she periodically receives various products about which she can write reviews if she wants to do so. If she receives a free bag of the new dog food through this program, her positive review would be considered an endorsement under the Guides. The distinction at issue is whether the suggestion of receiving something of value might influence a person's statements. You can pay for a positive review, as a reward for saying nice things, as long as the reviewer had no reason to think that they would get get something in return for a review. Taking your review to be an endorsement, as required here, Endorsements must reflect the honest opinions, findings, beliefs, or experience of the endorser. The regulation does not require you to reveal every thing that came into your mind in writing the review, but it is pretty clear that suppressing the concern about vaccination paperwork and the star count constitutes a dishonest statement of opinion of the endorser. Material connections must also be revealed: When there exists a connection between the endorser and the seller of the advertised product that might materially affect the weight or credibility of the endorsement (i.e., the connection is not reasonably expected by the audience), such connection must be fully disclosed. For example, when an endorser who appears in a television commercial is neither represented in the advertisement as an expert nor is known to a significant portion of the viewing public, then the advertiser should clearly and conspicuously disclose either the payment or promise of compensation prior to and in exchange for the endorsement or the fact that the endorser knew or had reason to know or to believe that if the endorsement favored the advertised product some benefit, such as an appearance on television, would be extended to the endorser In the 7th example under material disclosure, they describe a blogger who received something of value in connection with a review: the blogger should clearly and conspicuously disclose that he received the gaming system free of charge I should point out that these regulations are written by the FTC, and the implied interpretation (such as that the blogger should disclose... with no clearly stated penalty for failure to disclose) is an FTC interpretation. 15 USC 52 prohibits false advertisements for services affecting commerce. This is the jurisdictional aspect of their complaint against Cure Encapsulations, where defendants paid for reviews on a third-party website (this case involves a relationship between defendant and a fourth-party company that apparently hunts for and pays reviewers). This is apparently the first instance in which the FTC has gone against a business for paying for reviews on a third party web site, so it's not a foregone conclusion that they will prevail in court. Still, Chevron deference means that they will probably win at least on the jurisdictional question. The main difference is that in the Cure Encapsulation case, the violation was even more egregious in that the individuals were not even customers, and in this instance the would-(not)-be review was not the honest opinion of the endorser.
So-called AI software does not enjoy a special legal status (at present: one never knows what new law might be added). The question of whether any software can be distributed "safely" or "responsibly" is also not a legal issue. Nor is "true sentience" a relevant consideration, and nothing is guaranteed. When you distribute software of any kind, there is an implied warranty that the product is "fit", and if software kills you, you may be able to sue the creator for negligence. A software creator may then want to disclaim liability, by saying "WARNING: THIS PROGRAM MAY KILL YOU. OCP IS NOT LIABLE FOR ANY INJURIES ARISING FROM USE OF THIS PRODUCT". This may or may not actually remove liability. In the UK "liability for negligence occasioning death or personal injury cannot be excluded", so such a disclaimer will not prevent a suit against the manufacturer. In the US, the issue is determined at the level of the state – here is a summary of the law in the states. Probably the primary question would be whether such a disclaimer is an unconscionable term, and the second question is whether the act constituted gross negligence (not simply "negligence"). Mississippi exceptionally does not allow disclaimers, but even then, it does allow disclaiming liability when it comes to computer hardware and software. A software disclaimer is not inherently unconscionable, though perhaps some specific disclaimer would be found to be. Courts typically disfavor disclaimers in the case of gross negligence, and again determining what constitutes "gross negligence" is determined on a state by state basis. If the act shows "reckless indifference to the rights of others" and "failure to use even slight care or conduct that is so careless as to show com­plete disregard for the rights and safety of others", then the act might be grossly negligent.
A partial answer (for a manufacturer) is "look it up" – that may tell you if a determination has been made by the FDA. If so, it is not new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product (the FDA says). The legal part doesn't explain how it is scientifically determine that an inactive ingredient raises safety concerns but to take on example, wheat gluten is in the Inactive Ingredient Guide. This article gives a bit of analysis of the factors that sponsors have to consider in shouldering their burden of proof. If you want to manufacture a new vaccine, you have to show (the FDA) that it is safe. If you dilute the vaccine with water, that ingredient is not a "safety factor". Benzalkonium chloride could be (you would have to show that it isn't), and if it is, that regulation requires you to list it. What's not specified clearly is how many adverse reactions per million doses constitute being a safety factor.