Legality and liability of writing medical software by someone who is not a health care practitioner Is a person who is a non health care practitioner (NHCP) allowed to write and distribute software for use by NHCPs? If so, will the liability be any different than that of any other software? Let's take a simple example: say a software company wants to write an app for checking one's eyesight. A user will answer questions based on pictures shown on the screen and distance from screen etc., and will self determine their eyesight health. The software will contain a short warning that the installing user will have to confirm to have read, that it was written by a NHCP. Would this be legal? Could a user successfully sue the software company after a misdiagnosis by the software's fault? Assuming the fault is unintentional, of course. EDIT Perhaps I wasn't clear. I just wrote The software will contain a short warning that ... it was written by a NHCP. What I meant was more than that, that this software is not sold as an official "medical instrument" and should be treated as such. Much like alternative medicines are sold expressly for the treatment of certain ailments, but presumably do not fall under the medical category as long as they are clearly labeled as non-medicines. Would labeling the software as such relieve such software from the burden of being approved in advance by the FDA (as seems to be the case according to an answer below)?
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).
1) I saw that no where during registration you actually tell what your work does, you only fill up details, how exactly is it protecting you if you don't specify? For example I have a computer program/website that do something, how exactly the copyright protects you if you did not specify about it? A copyright protects a particular single expression of an idea and versions that are derived from that particular expression. When you copyright software you have to provide approximately 50 pages of printed code so as to make it possible to distinguish your code from someone else's and you generally deposit a full copy with the Library of Congress. The ideas in the computer program are not protected. You only protect the exact language of the code in the computer program and other programs that use that exact language as a starting point. If someone reverse engineers a way to achieve the same process or outcome with different code language (or even comes up with exactly the same code language without ever looking at the language used in your code) then their software does not infringe on your copyright. To protect the ideas in a computer program you need a patent. 2) If I am a non-us citizen, do I need to select in State "Non-US", or leave it blank on "Select"? Because it allows me to complete registration with either. State "Non-US" refers to where you are located, not to your citizenship. If you are located outside the U.S., then you select "Non-US" and if you are located in a U.S. state, but are a non-citizen, you select the state where you are located. The answer does not affect the validity of your copyright. It is used for economic statistics and to determine where the copyright office should locate its own offices to be maximally useful to the public.
This is &quot;Topic #601&quot; in various ForwardHealth interpretative statements about BadgerCare Plus and Medicaid. The last 3 paragraphs say: When commercial health insurance plans require members to use a designated network of providers, non-network (i.e., providers who do not have a contract with the member's commercial health insurance plan) will be reimbursed by the commercial health insurance plan only if they obtain a referral or provide an emergency service. Except for emergency services and covered services that are not covered under the commercial health insurance plan, members enrolled in both a commercial health insurance plan and BadgerCare Plus or Wisconsin Medicaid (i.e., state-contracted MCO (managed care organization), fee-for-service) are required to receive services from providers affiliated with the commercial health insurance plan. In this situation, providers are required to refer the members to the commercial health insurance plan's network providers. This is necessary because commercial health insurance is always primary to BadgerCare Plus. BadgerCare Plus and Wisconsin Medicaid will not reimburse the provider if the commercial health insurance plan denied or would deny payment because a service otherwise covered under the commercial health insurance plan was performed by a provider outside the plan. In addition, if a member receives a covered service outside their commercial health insurance plan, the provider cannot collect payment from the member. If we take these statements by the Dept. of Health Services as correct interpretations of the law, then it seems that their interpretation is correct: &quot;providers are required to refer the members to the commercial health insurance plan's network providers&quot; (you as a patient have no choice) and &quot;the provider cannot collect payment from the member&quot; (they are encouraged to refer you to a network provider, because they are prohibited by law from taking payment from you). If you had received the services from the provider and not mentioned any insurance, this would have been treated as a normal doctor-patient case, and they would not know that the state would prohibit them from receiving payment from you. By going through the motions with insurance, I regret to say that you exposed them to relevant knowledge which they cannot take back or deny. The fraud would be between the provider and the state, via the provider's relation with this program. That does not endorse the DHS legal interpretation, but since they are the ones who wrote the regulations, it is fairly likely that (by definition) they got it right.
Under your proposal, the author cannot effectively use the software at all, much less sell his creative efforts. The EULA clearly states that copyright is automatically transferred to the vendor when a document is created. The author gets started, writes &quot;It was a dark and stormy night&quot; then has a moment of writer's block, saves and closes, takes a walk, then tries again. The author has transferred copyright in the work to vendor, and needs vendor's permission to make revisions. So you have to tweak the EULA to grant automatic permission to author to create derivative works (revisions), and to distribute. A more effective strategy would be to impose a revenue-sharing formula on any commercially-exploited work created using the software, rather than attempt to directly seize the intellectual property. The CC &quot;NC&quot; license attribute is a distant version of what you are looking for - it prohibit any money-making use of the software. What you would add to that is a condition that the software can be used commercially, provided a certain compensation be rendered. You would of course have to be very clear in advance about what was actually agreed to.
You can license the use of your IP only for certain uses, for example (most commonly) &quot;non-commercial&quot;. The general template of permission is &quot;You have permission to ___ as long as you ___&quot;. What the user is permitted to do, in your scheme, is something along the lines of &quot;only distribute the output in this manner&quot;, or &quot;not distribute code developed with this tool anywhere else&quot;. It's up to you to prove that someone violated that condition, if they did.
Late to the party, but I'll answer anyways. In general, providers have a lot of wiggle room when sharing information with parents, on condition that the patient hasn't explicitly objected despite having opportunity to do so. HIPAA allows the provider to make a judgment call on whether such information can be shared without explicit consent: Quoting Title 45 § 164.510 : (i) Obtains the individual's agreement; (ii) Provides the individual with the opportunity to object to the disclosure, and the individual does not express an objection; or (iii) Reasonably infers from the circumstances, based the exercise of professional judgment, that the individual does not object to the disclosure. HHS does discuss disclosure to family members in their FAQ : A covered entity is permitted to share information with a family member or other person involved in an individual’s care or payment for care as long as the individual does not object. A parent of a child who has just turned 18 is likely still somewhat involved in the child's care, so, absent either an objection or a reason to believe the child would object if asked, sharing is probably not a violation.
I'm wondering whos responsible for this code if people start using it? The user. Can the people using it that think its under GPL in any way get in trouble for it or be made to remove it from their projects? Yes, they can be sued (successfully) for copyright violation. It’s not enough that you think you have permission from the copyright holder - you actually have to have permission. The law places the onus on the copier to seek out and get permission from the copyright holder. In theory, someone deceived in this way could sue the repo poster(s) for misrepresentation, however, there are practical issues about finding them, having them in an accessible jurisdiction and if they are judgement proof. Copyright law was created to protect physical books and paintings - it doesn’t really fit with digital methods of reproduction but it is the law. It doesn’t matter that complying with it can be hard bordering on impossible - comply with it you must.
The main US law that governs patient access to medical records is called HIPAA, the Health Insurance Portability and Accountability Act of 1996. Here is a brief summary of the patient record provisions from the federal Department of Health and Human Services. There are further details, intended for providers, here. In general, you are entitled to receive a copy of your records, or to have them sent to another doctor. But they can charge a reasonable fee to cover the costs of copying and mailing the records. I am not sure how this applies to a physical model: whether the doctor would be required to send the original or to make a copy (which could be expensive), or whether it would be considered a "record" at all for the purposes of this law.