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After a hospital visit(not a mental hospital), I had requested a copy of all my records for the entire stay. They said they won't send them to me until one of the psychiatrists I worked with approves it. Is this legal?
Yes, you are entitled to access your medical records!Yes, you are entitled to access your medical records! However, you must complete certain forms and pay a prescribed fee per page (photocopy are approximately 20c a page).You are able to access your file or medical records via other means:email,phone,hard/photocopy,electronic record,in person (I recommend the patient go through their file with their clinician-you can ask questions and get a detailed explanation),letting you view it at the health service,sending a copy to you,giving you a USB copy.Your Rights To Access Your RecordsFreedom of Information laws and the fact that it’s your medical record means that the hospital or your Doctor must give you a copy of your progress notes or files.The psychiatrist or other clinicians are able to redact or blackout certain sections of your file if they satisfy or meet the criteria set out in the Freedom of Information Exemption clauses. For example, page 10–15 of your file may be blacked out-legally.When Can Your Health Service Refuse To Give You Your Medical RecordsYour health service or psychiatrist can decline a request by you for access to your medical records under the following circumstances:the health service believes that access to your records may threaten your or someone else’s life, health or safetyaccess may adversely impact someone else’s privacygiving access would be unlawful.As stated above, your health service provider can block out sections of your file if you meet any of the above criteria.Time FrameYour medical records must be provided to you within 30 days of you making a formal application. However, a health service is able to make a request for an extension of 30 days to give you the requested medical records.What Happens If Your Health Service Refuses To Give You Access To Your Medical Records?If your health service provider refuses to give you access to your medical records then they must notify you via a written notice telling you why.You are entitled to complain about their refusal to the relevant state organisation.A committee will review the case and make a determination. Their decision will be informed by relevant state laws.Exceptions To The Above-Mentioned RulesPsychiatrists Psychotherapy NotesIn some states of the USA, Psychiatrist’s that are covered by HIPAA can deny patients access to their psychotherapy notes. Hence, these notes are said to be different to a formal assessment and/or diagnostic information.The reasoning behind this rule or exception is that psychotherapy notes are considered to be separate personal notes that psychiatrist’s use for their own purpose. Moreover, therapy notes may contain sensitive information that is not relevant to others (besides the psychiatrist).However, the HIPAA law states that a patient may authorize the release of their psychotherapy notes to a third party. For example, you can request that your therapy notes be released to a friend, family member an attorney, another health service or Doctor.The psychiatrists must comply with this authorisation!If they do not, you can take them to court and sue them. However, you would be better off making a complaint to the psychiatrist state registration board.The psychiatrist’s registration board will force the psychiatrist to comply with the above-mentioned HIPAA law.Kamal
What are the best practices and requirements/restrictions for use of social media spaces/networks to recruit participants for clinical trials research?
Without appreciation of legislation, regulations and site management due diligence the preservation of clinical trial integrity becomes threatened and liability concerns may arise. Therefore when a digital media initiative such as recruitment via a social media system is implemented, one must prepare accordingly and ensure commitment to the development, implementation and ongoing maintenance of an integrated Quality Management System for social media usage. Commitment to these responsibilities will ensure compliance with statutory legislation, regulations and guidelines that govern Human Research Standards.Current Clinical Trial Regulations regarding Social Media (US/Australia)The FDA Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, was published in January 2014. Importantly, as a reference this guide is clearly described as ‘for comment purposes only’. As Thomas, 2014 noted, this is hardly definitive, nor does it “create or confer any rights for or on any person and does not operate to bind FDA or the public.” The main points covered by the guide and as explored by Thomas include:That a company (or firm) is essentially responsible for communications and/or promotional advertisements on sites that are either owned, created, controlled, influenced, or operated by, or on behalf of that company. This includes websites, and Facebook pages that in this context are linked to recruitment campaigns.That under particular circumstances, a company may be responsible for publicity on third-party sites. From a site management perspective, any and all promotional materials and/or advertisements including text and images that relate to a clinical trial and recruitment for such a trial, must be endorsed prior to any use by the Sponsor. Subsequently after this initial sponsor approval, social media collateral must be submitted to the HREC/IRB for their approval.A company is responsible for any content or posts created by an employee or person who may be acting on behalf of the company to promote the companies services/product. Establishment and responsible site management governed by internal recruitment/advertisement operating procedures and social media policies allows a systematic approach to distribution of posts and advertisement sets, blogs, interactive conversations, complaints management and implementation of corrective actions.For fixed or static promotional materials such as advertisement layouts on Facebook and study specific websites, there are no significant additions to current regulations within the guide. Fundamentally the FDA requires:That an Human Research Ethics Committee (HREC) or Institutional Review Board (IRB) review and have authority to approve, require modifications in, or disapprove all research activities covered by the IRB regulationsThat direct advertising for study subjects is considered to be the start of the informed consent and subject selection process and therefore all advertisements including social media’s should be reviewed and approved by the IRB as part of the package for initial review. That is submitted as static images, with all associated text included for specific review and appropriate approvals. For Facebook submissions, you will need to include the exact text used as well as all images and links that are included. A web page will require a visual of the page layout/s, including text as well as any links provided for the participants. It may be handy, and save time in the long run to discuss with your nominated HREC/IRB, prior to application to see if they have a preferred submission layout for social media advertisement designs and sets. If you work closely with your HREC/IRB from the outset they may be able to provide expedited review for social media posts during the course of enrolment.HREC’s and IRBs are to review the proposed advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol.Basically the same requirements are recommended in Australia by the Therapeutic Goods Administration (TGA) with guidance provided by the Therapeutic Goods Advertising Code 2015. The code stipulates that an advertisement for therapeutic goods must (amongst other conditions):Comply with the statute and common law of the Commonwealth, States and Territories; andcontain correct and balanced statements only and claims which the sponsor has already verified;they may not be likely to arouse unwarranted and unrealistic expectations of product effectiveness, or;mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions.Specific national health authority regulations and industry standards provide wide ranging frameworks within which Pharmaceutical/Biotechnology companies should operate although there are numerous relevant omissions noted such as those surrounding control of social networking sites, sponsor monitoring requirements and source material verification processes. For clinical trial sites specifically, it is fair to say that besides standard privacy legislation, firm guidelines and best practice measures for social media governance are next to non-existent. In the absence of standard industry guidelines, all the stakeholders involved in social media recruitment should themselves, or be satisfied that a specialist vendor has, established internal standard operating procedures outlining acceptable practices and ethical standards required for social media recruitment and monitoring of digital recruitment operations. These standard operating procedures should detail corrective action responses in the event that these requirements are not met.If social media plans implemented at site include collection of participant or ‘enquirer’ information such as contact information and pre-screening responses, or if there is even the possibility that participants will provide data, sites need to be especially careful. Sites must consider what participant information is appropriate to store and how it will be then utilised and this must be carefully measured against collecting anything subject to HIPAA rules and/or Privacy Act restrictions. It is therefore vitally important that any application of data collection via social media adheres to the Australian Privacy Principles (APP) under the Privacy Act 1988. It is advised in this respect, as a measure of quality management, to have a documented Privacy policy that is freely accessible to those who inquire in prospective studies and displayed in the facility.The US Privacy Rule protects all ‘individually identifiable health information’ held or transmitted by a covered entity. This health information includes:The individuals past, present or future physical or mental health or condition,The provision of health care to the individual orThe past, present, or future payment for the provision of healthcare to the individual.The basic principle of the rule is that health information may not be used or disclosed unless:The privacy rule permitsThe individual who is subject to the information authorises in writingFor research purposes the rule allows use of disclosure of protected health information without an individual’s authorisation provided prior obtainment of documentation that an alteration or waiver of an individual’s authorisation for the use or disclosure of this information for research purposes has been approved by a HREC/IRB.With both of these privacy regulations (Australian and US) in mind and with reference to use of social media, it is imperative that sites do not collect or use protected health information without clearly obtaining informed consent first. Additonally those whose protected information has been collected should be afforded the opportunity to withdraw consent at any time. This can be enabled by sites by providing ‘opt-in’ and subsequent ‘opt-out’ informed consent disclaimers on digital platforms or study specific systems, creation and access for data collection policies and even custom designing systems where enquirers for clinical trial via social media have to provide consent before being able to actually progress through a screening process. Customers of a clinical trial site must always have the opportunity to contact management with complaints and quality improvements should be administered in response to these in case of a breach. With multiple levels of safeguards sites can ensure that those who inquire about a clinical trial can elect to either not have any of their information stored or know that if stored it is soundly protected and not misused.If you are using Facebook for social media recruitment you must also consider the following:There are terms and policies, which may affect campaign performance and overall riskYou cannot solely rely on your Facebook business account privacy settings. This only offers limited protection and additional information security systems need to be in place.Estimate, assess and manage risk throughout the lifecycle of the recruitment project, this means at least daily checks and response to correspondence.When commencing advertising online you must always consider the copyright and intellectual property implications of engaging with the public and others within the research industrySummarySo what in fact needs review and approval in regards to creating a social media recruitment campaign? Quite simply we can can say that any ‘direct advertising’ requires review. We have discussed that this can be in the form of websites, Facebook, and blogs and the formats of these which are subject to review include display ads, social network ads, social network pages, text messages, emails and rich-text media.In my point of view, through first-hand experience and with the consideration of the current literature, it seems reasonable that if data collected from inquiries generated via a social media trial recruitment advertisement, produced by a clinical trial site, that has been assessed and approved by both the sponsor and the HREC/IRB, and is:Obtained with consent;Is not misused, and;The privacy and confidentiality of our participants is maintained, and;Information security systems are in place, the result is not only are all the principles and regulations of GCP, Human Research Standards, HIPAA Privacy Rule and Australian Privacy Act compliance assured, we will find that in fact there is little to no difference between the ethical or legal compliance of social media and traditional media recruitment methods for studies.
Is there a need for tort reform in medical malpractice?
Tort Reform has become a phrase that is so often used and it’s meaning has become expanded to include definitions so diverse that anyone contemplating this question and answering it has little chance of success in avoiding the “pissing up a rope” syndrome (it all comes right back at you). It is almost impossible to tell from reading the replies here on this site to the question whether one’s own viewpoint has already been bantered back and forth about or not because of the pages and pages filled with strongly worded text that ranges from impassioned to pathological in terms of ‘meaning’ and relevance to the topic.It is an issue that causes anyone seriously contemplating it to feel strongly, often in opposing camps.It touches many a nerve in most people as they mull over the proverbs “sordid topic of coin” and “quality of life” (plus “U.S.” “Europe” and “Other Countries”It requires people to put themselves in the figurative shoes of people other than themselves and there are many unknowable factors involved in that venture anytime its required. The outcome of such a task is personality-driven and therefore defies most logic.Those first. Now this: I read over previous replies for hours. I’ll admit that I didn’t carefully read each page. Over and over I saw “physicians”, “attorneys” “dollars”, “lucrative”, “consumers”, “U.S. population” etc. I rarely read “sufferers”, “the person maimed or killed”, “depression”, “loss of abilities”, “tragic avoidable outcome”, “gross negligence”, “never event”, “physicians often lie to protect themselves or to protect their employer or colleagues”, “the victim may have to seek employment elsewhere or perhaps they won’t be able to find employment at all…or be able to even seek it”, “Victims learn what it’s like to have one’s entire life changed in an all-encompassing, negative, permanent way that might be devastating”. I don’t recall reading “failure to treat” (excessive testing be damned), or “insufficient examination performed” or “internally inconsistent case file that offers often contradictory statements about what occurred in the ER”.I haven’t read “malpractice cases must meet a very strict set of standards and rules before the lowest attorney on a totem pole will even give them a lazy glance” or “in order for attorneys to deem a case lucrative enough, it has to be so cut and dried that a toddler could take it to court and win” or “attorneys often begin by negotiating a large portion of any possible “proceeds” from any possible “compensation for a damaged life” that is higher than they deserve at 1/4 the price” or “attorneys seem to have every reason to represent victims with effective and thought-out strategies but counter intuitively they often don’t know important facts about what their client has actually suffered or why, despite having conferred about those facts usually at the client’s request”. I haven’t seen “attorney never read or ordered a copy of the client’s deposition” or “actively concealed fourteen months’ worth of pre-trial motions and counter motions, many related to something called ‘qualified ex parte interviews of the victims entire healthcare provider roster going back almost to their delivery room on the day they were born which translates to a violation of HIPAA privacy laws and worse because neither the victim or their attorney will be allowed to be present or know whom was interviewed about what” or “victim discovered the fourteen months worth of motions and counter motions (43 in all) on Free Law & Legal Information for Lawyers, Students, Business and the Public about a month before a rushed settlement was orchestrated”.I haven’t read much related to the fact that “attorneys and physicians are no better or worse than anyone else (generally speaking)” or “what do you suppose attorney X or doctor Y would do when he’s given a nosocomial infection and contraindicated treatment that exacerbates that infection until he or she is forced to go through six or more years of intense eye-pain, a corneal transplant to remove in depth and severe cornea scarring from the infection and that after two years of follow up is left blind in one eye and with a distorted visual field (in both eyes) constant distracting discomfort, a drooping left eyelid, eye redness, foreign body sensation for life or until the eye is removed which is unquestionably on the possible prognosis list, depression and anxiety that is ongoing and so severe that it scares the poor doctor or lawyer to the point where they aren’t sure they know themselves anymore, the ubiquitous (in most places) “post traumatic stress syndrome” that the poor docs and lawyers go through,. No siree Bob, I haven’t read much about “life-long recurrent cycles of increased light sensitivity and eye pain, photo phobia, and truly disturbing loss of equilibrium that caused the good lawyers and docs of the world to fall flat on their faces in their own homes” or “they sometimes are embarrassed to realize they’ve left their homes with a pair of shoes on that don’t match or “gee, I feel like I’m spending three times longer on personal grooming because gosh darn it, I used to be able to see myself much better in a mirror”. What about “a future filled with thoughts of contentious office visits with defensive, often sullen doctors, whom aware that the issue is related to “med mal”, will mete out diagnostic and prognostic data very, very carefully and over a long period of time but always in a way that is progressively more problematic.”Shucks, I don’t think I read “no shared liability on the victim’s part” once. Not to mention that “anyone who initiates a medical malpractice case will be grilled about their own past history since grade school - every aspect of their personality will be examined by the defense AND by their own hired attorney to make sure they don’t have any (no matter how slight) ‘stain’ in their past or in the way they look, act, talk, dress, drink coffee, or pick their nose that might sway a jury in a bad way”It wasn’t brought up about “depositions in which the defense attorney panel sits across from you and asks you personal, often irrelevant questions while you are sworn under oath by a court reporter to answer truthfully.” or that “ the issue is that your answers don’t matter- what’s really happening is that both legal teams are watching you to see how they think you will present in court to a jury in terms of being ‘sympathetic’ and the facts are secondary -its all about discrediting you as a human being.”I wonder if these fearful doctors also feel guilt when they write “I never told Mr. So and So to pressure patch his eye with non-sterile patches that I handed him in the ER which is notorious for the presence of the very bacterium that put the guy’s eye out - along with a roll of already-opened medical tape. I DENY that. I didn’t do it myself because Mr. So/So was driving home and it might have compromised his depth perception. Golly well, no there isn’t any note that I took a visual acuity exam that day but I assumed no changes to Mr. So and So’s vision because well uh, his left eye was “shut, secondary to pain” and “nothing” relieved the pain. What? Did that not already render Mr. So/so with compromised depth perception thereby busting me on my lame reasoning for why I deferred the guy outta the ER on a fast track? I guess you could say that but I’m not saying it. Oh by the way you see we did note (three times) on the admission chart that So/So is a contact lens wearer. in fact we wrote “removed contact lens yesterday and has had increased redness and photophobia with sterile discharge at this time” That kinda indicates an uninfected (yet) but dangerous corneal abrasion in this situation. “Gee, I didn’t use a slit lamp to evaluate the abrasion because …well it was being used somewhere else in the large hospital so I opted for a wood burn lamp device that magnifies the eye insufficiently to determine its status for treatment…what? heck NO I didn’t ask the on call ophthalmologist to consult - it was a Thursday evening..I mean it was after 5 pm for gosh sake. Yeah, I know I’m supposed to consult them routinely about these eye things at any hour of the day or night but..but anyway I DENY all of that because I wouldn’t have done that because it’s been known that pressure patching a contact lens wearer’s abrasion is a med school drop-out- level ‘no-no’ for at least twenty-five years…no sir, I deny it all and I don’t know how Mr. So an So knew how to perform a self-patch job later that evening …kee-rist I didn’t mimeograph the flyer your’e showing me that I gave him that evening myself! What do I admit? well, that I saw Mr. So and So on August thus and such 2011 in the ER”.It hasn’t been commented about but case file histories reading “Admitted 6:00 pm, discharged 6:33 pm; Treatment: deferred to home patient gonnA (sic) Drive” accompanied by a page with instructions on how to pressure patch an eye which is now never done on anyone but at one time was used for NON contact lens wearers and there is a huge reason for this distinction. Also a prescription for an ointment to be “changed four times daily by removing patch reapplying and re-patching” stunningly worded stupidity that screams ‘leave the patch on for days which it turns out couldn’t be done because the infection was so aggressive.Let me interject here: Did you know that there is a bacterium called Pseudomonas Aeruginosa? it is very very common on our planet and its extremely deadly and fast. It prefers to target ailing organisms and rarely invades a healthy organ like an eye unless there is an abrasion on the eye that came from contact lens wear. You see, contact lenses even when properly used over time create something called a biofilm. You won’t see this announced much by Cooper or Bausch and Lomb. but its been known in the medical field for decades (fun fact).ER physicians you might ask about contact lens wear as your own cornea is “melting” as they call it could grin broadly at you and might say “No, I’d never wear contact lenses myself, uh-uh” They might even come in a group to stare at your disintegrating eye since its, after all a teaching facility hospital and one might peer at it through a magnifier and announce the word “Wow” to the room. He might then look vaguely embarrassed as you look at him with your one available eye which can apparently still convey the emotion called “stunned”.Anyway, it wouldn’t surprise me to find that you, the reader doesn’t know this even if you use contact lenses, but a biofilm is a surface (microscopic) that forms from wearing contact lenses correctly for longer than a few months (no I don’t mean continually - I mean daily) on which various types of bacteria can attach themselves and live for decades inactive. Alternatively, a type of Pseudomonas aeruginosa that is often found in hospitals on opened rolls of medical tape and patches exists that is even more virulent because it has adapted to living in more sterile hospital settings. If a tiny tear appears in the eye’s epithelium (outer surface of cornea) its as though a hole suddenly opens up for the bacterium and they happily become RAPIDLY and AGGRESSIVELY invasive and can literally eat through your entire eye within 24 hours. Then the naughty little bugs can scamper right on in to the periorbital socket and kill your brain and of course, kill you but not usually before a whole lot of agony - you might evade the dying part but you bet you will endure a long period of the agony stage! Oh I forgot to mention that patching an eye with this situation creates a warm, dark and moist environment that the greedy little bugs are thrilled to death with while simultaneously robbing your eye of its only natural defense in the form of tears and blinking. This double whammy stimulates the hectic little bacteria to grow and grow like a Chia pet, only its not on a little piece of cardboard shaped like a dog or whatever- its growing IN to your eye socket and ‘necrotizing anything it encounters along the way. Any of these conditions alone might have been “mal” practice; all of them together is downright catastrophic and stupefyingly inexplicable in a professional setting with loads of fairly jolly participants!When this happens, even if you immediately seek care from an ophthalmologist who “specializes in corneal issues” he or she might turn visibly grey, tell you “you have a sight threatening and “rare” eye infection which I’m not equipped to treat…here (hands paper) go - NOW to this hospital in another city that at this point is about a three hour drive and a “specialist” will be waiting for you - that’s his name on the paper”.You might have a friend drive you and arrive only to find the “specialist is nowhere to be found. In fact, you may later discover that he was no specialist at all but instead was a doing a fellowship at the hospital with which the grey-faced doc has a professional relationship since he himself interned there years before. Puzzled, you and your friend (thank God for him) look around the large empty area that is designated for the treatment of eyes in this huge hospital setting. You might even be familiar with the place from escorting yet another friend to that very hospital regularly for cancer treatments - so ya sort of know where people are supposed to be but you may not see anyone around just then - oh look at that overhead clock on the wall it is five minutes past six pm! No wonder the hospital gangs all gone home.So, what is this insignificant “victim” in our debate here supposed to do now? well the only thing I guess is to present at the hospital’s ER and explain what has happened. Done. Oh, the record indicates “referred by: ‘walk-in’ gee, that’s odd, the triage physician was told that it was an emergency referral from Dr. Dummy. Odd too that the triage noted “suspect for Pseudomonas infection in left eye” (which everyone in the good old ER knows can rock your world or at least your eye right out of existence in less than a day ) on the admission record but still…Ok let’s sit here for eight hours while the hole in my eye grows by 1/3 in diameter (Dr. Dummy measured it before he turned grey and sent me here for comparison purposes) and an unknown increase in penetration of my eye tissue. Do I want pain medication, asks the triage doc every couple of hours by sticking her head out the door in to the waiting area? No, I’d rather get treatment. Ok. And all of this is just the beginning of the story.I wonder if Dr. X and Dr. Dummy feel shocked when Mr. So and So turns out to have a very, very good memory and can recite details like “These were his discharge instructions: he went to a cabinet in the back of the exam room and got from a lower drawer in it patches and tape, walked over and using hand gestures and a verbal explanation, showed me how to pressure patch my eye when I got home that night…the next morning, after following his instructions, I woke up in excruciating pain. I went in to the bathroom, removed the patch and almost heaved when I saw the green goo oozing from my eye’s socket. Once I was able to look in to the orbit, I saw a white pus-like substance covering the entire Iris and Schera of the eye which I had to hold open with a finger in order to examine it with my right eye…after that my vision was measured in terms of how many hands I could count being waved in the doctor’s exam room for months until it reached it’s current and if I’m lucky permanent 20/2000 acuity status and that’s best corrected…I’ve been in pain ever since and with one blind eye and distorted vision overall” I actually rather doubt that they do feel even mild surprise. The goodies in store at that point included finding out about how you don’t drive your car anymore or go anywhere because, well you can’t see to drive and when you tried doing it few times you could have killed someone else or yourself on the road. Then while the docs are all scrambling around those first couple of years you realize that you barely leave your home, have lost interest in EVERYTHING, including the things you used to love doing because you kinda can’t do them anymore. Work? ha! You are a perfectionist about you work product and always have been. You've worked since you were 12 years old with your first paper route and you always try to be a good team player. What good are you going to be now when it takes you five hours to write a stupid post on a free web site that’s still rife with grammatical and spelling errors, most likely - you just can’t see them. Oh yeah, I was a commercial personal property and real property valuation analyst - that was my primary vocation. What does it require most of all? observation power and visual clarity.So, you want to debate reform? Have at it but be warned: the above story is not only true, it’s just the tip of the iceberg.
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