Does withholding non-medical information affect medical consent? In an episode of the medical drama 'House', a patient needing a liver transplant is offered a live donation from her girlfriend. During the episode there's a continual argument over the ethics of whether they should tell the donor that the patient was about to break up with her prior to the hospital admission. I am wondering whether the doctor and patient, both strongly believing that the donor would withdraw consent if she knew, would be liable to lawsuit or even committed a crime by hiding this information? Would the doctors be obliged to tell the donor or even be allowed if they wanted to as it is not sensitive medical information?
The primary question is whether remaining silent would constitute a breech of medical ethics. The pertinent ethical principle is AMA Opinion 2.15 One of the requirements is that the donor be assigned an advocate team whose interest is the donor, not the patient, and these should generally be distinct individuals in order to avoid conflict of interest. Assuming that the donor's team is aware of this fact, they have a duty to disclose it, since it materially affects the donor's willingness to donate the organ. The ethical opinion does not specifically address &quot;patient breaking up with a directed donor&quot;, but there is a general obligation to share information, and it would probably be found to be a breach of medical ethics to suppress relevant non-medical information. The ethics of directed donation from live donors is not well-developed. I will mention that Potential donors must be informed that they may withdraw from donation at any time before undergoing the operation and that, should this occur, the health care team is committed to protect the potential donor from pressures to reveal the reasons for withdrawal. If the potential donor withdraws, the health care team should report simply that the individual was unsuitable for donation. From the outset, all involved parties must agree that the reasons why any potential donor does not donate will remain confidential for the potential donor’s protection. In situations of paired, domino, or chain donation withdrawal must still be permitted. Physicians should make special efforts to present a clear and comprehensive description of the commitment being made by the donor and the implications for other parties to the paired donation during the informed consent process. Neither team can tell the patient that the reason the girlfriend withdrew was because they ratted him out (anyhow, we can suppose she said something to him on her own). The hospital knows this fact, and has both a duty to the patient to solve a medical problem but also to the donor to be sure that the consent is informed. The hospital would be suppressing a fact relevant to the donor's willingness to undergo the operation, which is a breach of duty. This fact is not protected by HIPAA, or any other California statute, so does not supersede the obligation to reveal relevant facts.
No You say you won't disclose personal information, therefore, you can't disclose personal information. Now, if your privacy policy said &quot;We won't disclose your personal information except ...&quot; then, so long as you did the &quot;...&quot; that would be fine (subject to privacy law).
There is no time limit on performing a legal abortion. §2599-bb of the bill says that a physician may perform an abortion when, according to the practitioner's reasonable and good faith professional judgment based on the facts of the patient's case: the patient is within twenty-four weeks from the commencement of pregnancy, or there is an absence of fetal viability, or the abortion is necessary to protect the patient's life or health It is left to ordinary language interpretation to understand what "abortion" is. The ordinary meaning of abortion does not include act that follow birth or a child. The law as amended still defines homicide as conduct which causes the death of a person under circumstances constituting murder, manslaughter in the second degree, or criminally negligent homicide and deleted the clause which included the clause an unborn child with which a female has been pregnant for more than twenty-four weeks (this is how abortion past 24 weeks was formerly illegal). The definitions say that A person, when referring to the victim of a homicide, means a human being who has been born and is alive Once a fetus becomes a person by being born, the homicide statute prohibits killing the person. So apart from the fact that killing a person is not "an abortion", the law does not make it legal to kill any man being who has been born and who is alive. As for what constitutes "health", that is not delimited by law, that is, it says simply "health", not "physical health". In general, "health" without modifiers means any kind of health. In fact, in Doe v. Bolton, 410 U.S. 179 it was found that whether a particular operation is necessary for a patient's physical or mental health is a judgment that physicians are obviously called upon to make routinely whenever surgery is considered
Disclaimer: I am not familiar with US law, so this answer is from a general perspective. It should apply in most jurisdictions, though. Are there any laws or regulations which I can use to convince a hospital's billing department to talk to me, despite the fact that they have a clear policy otherwise? No, I don't think so. A company or organization is generally free to decide for themselves who will or will not communicate with you - I don't think there is any law giving you a right to choose. How would this even work? What if the people you ask to talk to are overworked, on vacation or just not qualified? However - you do have another, more important right: To be considered valid, a bill must provide credible evidence that the charges are justified. You cannot just ask someone to give you money, you must actually provide a reason why you are owed money. In this case, this means the hospital must send you a bill that you can understand and verify. To get this: First, stop bugging them over the phone. Once a point is reached where legal action seems likely (like in your case), any information you get is only really useful to you when in writing. So do everything in writing. It's fine to talk to them if it helps solve the problem - but insist on getting things in writing afterwards. The first thing you need to write is a formal letter that you refuse to accept the bill, because you cannot verify it. Outline in details what parts you cannot understand/verify, and ask for the information you need (such as what the codes mean). Once you have received a satisfatory explanation of the bill (which may take multiple letters), you go through it with a fine comb, and dispute any items that you think are unjustified. You may need the help of a lawyer to exercise these steps, but in principle you can probably do it on your own, too. Whether you get a lawyer is ultimately a trade-off (making a mistake may cost you money, but hiring a lawyer costs money, too). A first consultation with a lawyer is probably not too costly (ask first!), and may help you to decide whether you need more assistance.
Since your consent is not required in Texas, revocation is irrelevant. Restrictions of use of recordings flow from the legal nature of the recording itself, so there is no provision saying, for example, that only one party needs to consent for just recording, but all parties must consent to make any use of the recording. Since these laws were devised to regulate the practice of wearing a wire and collecting evidence of crimes, requiring consent from all parties would be counterproductive to the purposes of the law. You could try drafting a contract where you pay people to not record you (anybody who doesn't sign, you shouldn't talk to them), but enforcement could be tricky, so I would not try a DIY contract: get a lawyer. You would have to show that you were harmed by them making an unconsented recording. It should be in the form of a contract where you give something of value in exchange for something of value, which is a thing typically enforced by the courts. Also bear in mind that even in an all-party state, if you know that you are being recorded, you cannot just say &quot;I do not consent&quot;, you have to stop talking. Continuing to talk when notified that there is or may be a recording constitutes implied consent, which is why on the phone companies often announce via recording that the conversation may be monitored, and they do not ask &quot;Do you consent&quot;. By not hanging up, you consented.
If an employee takes home information that his or her employer considers confidential, that would be a matter of company policy. The employer could discipline or fire the employee if it learned of the incident, and chose to act. If the information is considered to be a trade secret, or part of one, disclosing it or mishandling it so as to risk disclosure could be a crime under US law. However, only in unusual cases is criminal action taken on such matters, normally it is left to civil lawsuits or internal company action. I do not know if Canada has a similar law.
You can write anything you want (basic First Amendment protections): the question is whether one would be liable for damage that arises from what you're written, or whether you can distribute what you've written. Distribution may be restricted, thanks to the Commerce Clause (hence FDA regulations, which figure prominently in the analysis). Most software writers are not medical practitioners, and vice versa, and what the software writer does is implement something described by a competent medical practitioner. It is logically possible that a med. practitioner might also try to write software (no problem) and distribute it (possibly a problem); or, a software writer might read up on something on Wikipedia and try to implement it (again, no problem) or distribute it (possible problem). Damages can be sorted into two categories, implementation errors and scientific errors, and having ruled out deliberate sabotage, we are left with negligence. If the software writer failed to use suitable care in writing code that sums a set of numbers, the software writer has been negligent. If the person purporting to have the qualified scientific knowledge mis-states the formula, that person has been negligent. It is possible for many parties to be negligent (the programmer failed to be diligent in understanding the software requirements; the medical professional failed to adequately explain what was required of the program). The FDA does regulate medical devices, and "device" is construed pretty broadly (condoms are non-exempt class 2 medical devices). There is FDA guidance on medical software which makes it clear that the device manufacturer shoulders the regulatory burden. Anytime you manufacture a tangible thing (which is within the scope of FDA regulation for medical devices), you have to have the thing approved. Many (most?) medical devices implement software, and are thus within the scope of FDA scrutiny. It is not illegal to write software that ends up being implemented in an unapproved medical device, but the unapproved medical device itself is illegal. It is reasonably likely that purported medical software (not a gadget with software build in) would be held to be a non-exempt device. To know if something is exempt, you would look at the exemptions list, and determine that your program (or thing) is not on or implied by anything on that list. The visual acuity eye chart is a class 1 exempt item, as is the manual toothbrush. There is no way to specifically look for things that are only software, or that contain software, so the search through the list would have to be guided by knowledge of the subject area. Canada is helpful in explaining when software is a regulated medical device. This is non-probative w.r.t. US law but gives you an idea what is likely to be considered a "device". Under Canadian law, the software would be clearly a regulated medical device. The FDA has a power-point that attempts to say something about the matter which warns you that you are on your own and "You will need to go back to study and use the source regulatory documents" to make the determination. Eventually, slide 13, they hint that if you intend the software to be used in diagnosis, prevention, or treatment, then it is a device (so, yes, the aforementioned software would be a device, and probably not exempt from regulations). General purpose software (word processors, web browsers, communications software, etc.) are not indented to be used for a regulated purpose, although they can be so used, and thus they are probably not subject to FDA regulation. There is a murky relationship between regulatory approval and liability. Being approved by the government does not convey immunity to negligence suits (see Wyeth v. Levine), but being approved can have weight in determining whether a party was negligent, since regulatory scrutiny ostensibly filters out errors that could have been caught. Federal approval does not preempt state tort law, as the court ruled. Regulations pertaining to medical devices hold for anything that qualifies as a device, and is not defined (negatively) in terms of disclaimers. If you sell a medical device but label it saying "this is not a medical device, it is not created by a competent medical practitioner", that doesn't make it not a medical device. Unfortunately, what counts as a regulated device is based on intended use, and there is an obvious connection between disclaimers and intentions. Taking MS Word as an example, MS does not as far as I know say that "Word is not intended to be used as a medical device". It can certainly be used to diagnose, teat, and prevent medical conditions, but so too can a screw driver or pretty much anything else. The number of non-medical uses vastly outweigh the medical uses, so it would be deemed not to be a regulated device. A program which prescribed a set of prayers to be uttered in case of illness would be subject to First Amendment override of any FDA regulations. Quack medical devices are prohibited (that's why there is regulation of devices in the first place), but discerning the fine line between permitted actions based on nutty beliefs and forbidden actions is not easy. The FDA also has guidance on the distinction between "Complementary and Alternative Medicine", which does not clearly state that, for example, a software reading of your cakra-energies based on a computer program's questions is not a medical device. They do say of mind-body medicine (mentioning yoga, biofeedback and tai chi as examples) that "CAM practices in this domain would not be subject to our jurisdiction under the Act or the PHS Act", but then say "any equipment or other products used as part of the practice of mind-body medicine may be subject to FDA regulation, depending on the nature of the product and its intended use" (hence a yoga-enabling program may be subject to regulation).
In California, all parties to a conversation (people being recorded) have to agree to a recording. There are no special rules pertaining to husbands and wives. It is sufficient that the parties are aware that the recording is being made and they continue to talk, knowing that fact. There are exceptions, under Cal. Penal 633.5, in that surreptitious recordings are allowed in order to gather evidence of "extortion, kidnapping, bribery, any felony involving violence against the person, or a violation of Section 653m". To be used as evidence, there are also "predicate rules" to the effect that you have to prove who the voices are from, that the recording hasn't been altered, and that the recording is reliable (e.g., there isn't a mysterious 18 minute gap).