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Legal Considerations
Michael J. Meehan
The dawn of the twenty-first century brought with it many of the same legal challenges for physicians, including colon and rectal disease practitioners, as did the latter half of the twenti- eth century. The ever-increasing frequency and often crushing severity of malpractice claims and lawsuits, databank report- ing, Web-based consumer claims data, new privacy require- ments, increasing clinical demands, greater government regulation and enforcement activity, and spiraling malpractice premiums have caused many physicians to leave practice, retire early, or relocate to more defendant-friendly lawsuit jurisdictions. This chapter addresses issues related to these concerns—from communication to documentation, from prac- tice to research—as they relate to colon and rectal surgeons.
Medical Malpractice
Elements of Malpractice
In July 2003, a 12-day courtroom trial occurred in Seattle, Washington. The plaintiff, a married 53-year-old computer salesman, had presented to his family physician with rectal bleeding and a painful anal lump with the appearance of a hemorrhoid. When the condition did not improve with treat- ment, the patient was referred to a general surgeon. After evaluation, the surgeon concluded that the patient had a hem- orrhoid and recommended a hemorrhoidectomy. The patient, saying he thought the condition was improving, declined the procedure. The surgeon informed the patient that a hemor- rhoidectomy would be indicated if the condition did not con- tinue to improve and resolve. The patient next returned to the surgeon 4 months later, at which time a hemorrhoidectomy revealed advanced anal cancer. The patient received chemotherapy and radiation, developed impotence, and suf- fered two recurrences of the cancer, from which he was expected to die. The patient-plaintiff filed a lawsuit against both the family physician and the general surgeon contending that earlier diagnosis would have resulted in less extensive treatment and a prognosis of survival from the cancer. The
defense argued that both the family practitioner and the general surgeon acted appropriately and that an earlier diag- nosis would have made no difference in the treatment or the outcome. Fifteen medical and surgical experts were used in the case. The pre-suit demand of $ 2.75 million had been met with an offer of $125,000. At trial the plaintiff asked the jury to award $7 million. The defendants requested a defense ver- dict. The jury found in favor of the defendants and awarded no money.1
The elements that must be proved by a plaintiff to prevail in a medical malpractice case are determined by the laws of the various states. Thus, in this case, the verdict was governed by Washington state law. In general, medical malpractice is established when it is proved, by a preponderance of the evidence, that a patient sustained an injury as a result of an act or omission of a physician or surgeon that would not have occurred had the physician or surgeon exercised ordinary skill, care, and diligence.2 What a “physician or surgeon of ordinary skill, care, and diligence would or would not have done under like or similar conditions or circumstances” is called the standard of care. Family practitioners and surgical specialists, as in the Washington case described above, are usually held to different standards of care, depending on vari- ations in state law. The standard of care for a physician or sur- geon in the practice of a board-certified medical or surgical specialty should be that level of care expected of a reasonable specialist practicing medicine or surgery in that same specialty, regardless of geographical considerations or circumstances.3Negligence occurs when the care falls below the standard of care. A case can include single or multiple allegations of negligence.
When negligence is proved in the courtroom, the departure from the standard of care must also be a proximate cause of the injury to the patient for the plaintiff to prevail. Thus, there must be a cause and effect relationship between the care and the harm. For there to be a plaintiffs’ verdict, the jury must believe that 1) there was a departure from the standard of care, and 2) that the departure from the standard of care was a cause of the patient’s injury. For the defense to prevail, the jury must
believe that either 1) or 2) above were not proved by a pre- ponderance of the evidence—or that neither were proved.
Both of these issues were actively debated in the Washington case. 1) The recommendations, treatment, and decision to defer a hemorrhoidectomy were contested by both sides; 2) whether the cancer had metastasized before the critical involvement of the doctors was also argued. (If the cancer had metastasized before physician mismanage- ment, if any, then even a timely hemorrhoidectomy would not have changed the outcome or treatment—so physician mis- management could not have logically been the cause of the patient’s injuries).
In some cases, the defense attorneys will concede on item 1 above—negligence, if they think they cannot prevail on item 1 but if they think they can prevail on item 2—causation. Such a strategy may be challenging. Consider the following case tried to a Savannah, Georgia, jury in November 2001 in which defense attorneys conceded negligence and tried to convince a jury that the plaintiff was entitled to receive an award, but that the amount sought by the plaintiff exceeded that to which he should be entitled. The plaintiff had suffered a rectal tear when thrown from his vehicle during an automobile accident.
The trauma surgeons who tried to repair the tear negligently closed the proximal end of his colon and matured the distal end as the stoma. As a result, he suffered a complete obstruc- tion of his digestive tract for 7 days and developed a massive infection, causing the loss of approximately 70% of his abdominal wall. He was left with massive scarring, no abdominal muscles, only a thin layer of skin covering his intestines, and the prospect of constant diarrhea for the remainder of his life. The defendants conceded that the sta- pling procedure was improperly performed, but they disputed the extent of the patient’s injuries that was alleged by the plaintiff’s attorney, including more than $1.2 million arguably representing the present cash value of the patient’s future lost income. The jury was not asked whether the trauma surgeons had committed negligence, but rather whether all of the injuries complained of were caused by the negligence (whether too much money was being claimed for the injury).
Ultimately, the jury awarded the plaintiff $ 6.25 million.4
Recurring Malpractice Themes
A study of medical malpractice cases involving colon and rec- tal disease involved a retrospective review of all cases tried in the federal and state civil court system over a 21-year period from 1971 through 19915remains instructive today. The study identified 98 malpractice cases over that period of time from a computerized legal database. The 98 cases included 103 allegations of negligence. The nature and frequency of allega- tions were as follows:
●43%: Failure to timely diagnose disease (principally cancer and appendicitis)
●24%: Iatrogenic colon injury
●15%: Iatrogenic medical complications during diagnosis or treatment
●10%: Sphincter injury with fecal incontinence from anorec- tal surgery or midline episiotomy
●8%: Lack of informed consent (usually regarding extent of procedures or endoscopy)
Recent commentators have cautioned about patients who present with fully developed cancers within 4 years of colonoscopies that apparently cleared the colon of neoplasia.
The concern expressed is that the presenting patients may assume their colonoscopies were negligently performed, despite legitimate alternative explanations.6
A study reviewing 38 malpractice claims against radiolo- gists performing contrast examinations of the colon between 1985 and 1994 revealed the following major allegations: fail- ure to diagnose resulting in delay in treatment and death, and colon perforation attributed to improper performance.7
Risk management suggestions relevant to colon cancer screening include using authoritative screening guidelines, documenting informed consent and refusals, assessing family histories, recommending that family members of at-risk patients be contacted, repeating sigmoidoscopies and colono- scopies when the preparation is inadequate, and documenting both cecal intubation and careful withdrawal techniques.8
Lawsuit Stress
Most physicians experience stress when their professional care and judgment are criticized in a public lawsuit. The ini- tial stressor typically occurs when the claim letter, legal com- plaint, or insurance company notice arrives in the mail. The simple reality is that your chosen profession frequently lends itself to the frustrations and anxiety of litigation. Anger, uncertainty, and even depression are common symptoms among physician defendants. These emotions can be espe- cially intense in those individuals sued for the first time.
Communications with your attorney are confidential and are protected by a privilege similar to the physician–patient privilege. Attorneys representing physicians usually advise their clients not to discuss the case with others for fear of los- ing the protections available through the attorney–client priv- ilege. The tension and vulnerability that you may feel about being sued may be exacerbated by this inability to seek emo- tional comfort by discussing the case with colleagues and oth- ers. It is common to feel isolated—to assume that colleagues and even subordinates are talking about you and your lawsuit.
It is important to place your predicament in perspective; many of your colleagues have been in the same situation before you and others will be in the future.
If you are involved in a claim or lawsuit and are experi- encing any of these normal reactions to litigation or the threat of litigation, you should have a candid conversation with your attorney, risk manager, and/or insurance company claims representative. Many insurance companies and
medical institutions provide resources for defendant physi- cians that enable them to discuss their lawsuit and their feel- ings of uncertainty and isolation with counselors or colleagues in a protected manner. Conversations with psy- chotherapists are generally privileged and not admissible in the courtroom as evidence in the case. Remember that your emotional stability is critical to the successful defense of the litigation. You serve yourself best by sharing your feelings with your attorney and asking him or her for a way to receive emotional coaching throughout the stress of the lawsuit and afterward as well.
Informed Consent
Informed consent is a patient’s agreement to a medical proce- dure or other treatment after the person has been informed of the likely benefits, significant risks, and the alternatives of the treatment. The failure of a physician to obtain proper informed consent is often cited as a major component of med- ical malpractice litigation. In reality, few cases are prosecuted exclusively on the issue of informed consent, and juries do not customarily award damages solely for a lack of informed consent. Most malpractice lawsuits, however, contain a sup- plementary allegation that informed consent was not obtained. The informed consent discussion is at the heart of physician–patient communication and is usually an important component in the defense of the main medical or surgical issues in every case. You do not have to wait until the day of or the day before the procedure to obtain informed consent.
A study involving 60 patients who underwent either colono- scopies or esophagogastroduodenoscopies revealed that patients remember essentially the same information whether consent is obtained immediately before a procedure or several days earlier.9The physician should discuss the procedure or treatment with the patient and obtain and document informed consent as close to the date of the procedure or treatment as reasonably possible, e.g., within days to several weeks.
Allowing the patient some time to reflect on the risks, bene- fits, and alternatives before consenting is an ideal practice, depending on the urgency of the proposed treatment and the complexity of the patient’s decision.
Obtaining Informed Consent
Obtaining informed consent is primarily a physician obliga- tion. Nurses and other nonphysicians are not normally responsible for failing to obtain informed consent,10because they lack the requisite legal capacity to fully inform patients of issues on which only a physician is licensed to advise.
Hospitals, the typical employers of such professionals, do have an obligation to maintain an effective informed consent process within their institutions. Lack of informed consent claims may be successful if hospitals breach hospital stan- dards and other duties imposed by law, e.g., whereby a patient
is injured by an experimental procedure without being advised of the experimental study.11
Obtaining a patient’s informed consent involves more than securing a patient’s name on a form. It is a communication process in which the physician should discuss the following information with the patient12:
●The patient’s diagnosis, if known
●The nature and purpose of the proposed treatment or proce- dure
●The risks and benefits of a proposed treatment or procedure
●Alternatives (regardless of cost or insurance coverage)
●The risks and benefits of the alternatives
●The risks and benefits of not receiving or undergoing the treatment or procedure
Patients should be given the opportunity to ask questions and have their questions answered.
Proving a Case of Lack of Informed Consent
Depending on variations in state laws, plaintiff attorneys typ- ically must prove the following elements to establish a prima facie case of lack of informed consent by a physician:
●The physician failed to disclose to the patient and discuss the material risks and dangers inherently and potentially involved with respect to the proposed therapy, if any.
●The unrevealed risks and dangers which should have been disclosed by the physician actually materialize and were the proximate cause of injury to the patient, and
●A reasonable person in the position of the patient would have decided against the therapy had the material risks and dangers inherent and incidental to the treatment been dis- closed to him or her before the therapy.13
Whether risks are material is normally an issue decided by a jury.14Juries are often instructed that risks are normally con- sidered to be material if a reasonably prudent person would attach significance to the risk in deciding whether or not to accept the treatment. A risk that is either severe, such as death, or frequent are usually risks that are considered mate- rial. Some states regulate the specific information that must be conveyed to patients. Other states leave the determination of materiality to judges and expert witnesses. You should become familiar with the informed consent laws in the state where you practice. Withholding material risks from patients for cultural, ethnic, or paternalistic reasons is not acceptable.
Documentation of Informed Consent
Informed consent is usually documented with formal consent forms requiring the patient’s signature. Nearly all hospitals require the use of consent forms for inpatient procedures to comply with applicable law. This is done to abide by the stan- dards of the Joint Commission on Accreditation of Health Care Organization,15and to facilitate patient education of the
treatment information. Proper informed consent is a process and not just a form. Forms can be challenged and criticized in the courtroom. A form containing errors, or one that is incomplete, can distract a jury from the real issues involving informed consent.
Claims of lack of informed consent are most successfully defended when a jury is persuaded that the physician had a meaningful conversation with the patient. In addition to a consent form, a chart notation made by the doctor, in the doctor’s own words or handwriting, is usually very helpful.
A jury that believes that the physician never saw the patient, or had a brief or cursory discussion with the patient, may become more inclined to decide that a surgeon departed from the standard of care in performing the procedure. Producing a diagram that was drawn for the patient to explain the proce- dure can be persuasive for jurors. Similarly, patient informa- tion sheets or pamphlets are effective communication devices and serve well in the litigation defense.
Listen carefully to your patients’ questions. Answer ques- tions in a friendly but candid manner. Note in the chart the presence of any family members who are present for the informed consent discussion.
Patients who are minors—usually those less than 18 years of age—may not normally consent for themselves. There are limited exceptions to that rule, e.g., patients who are living apart from their parents, or patients who are sufficiently mature to provide consent. Regardless of a minor’s emanci- pation or maturity, it is wise to always obtain parental or cus- todial consent for elective procedures performed on minors.
In addition to creating potential liability, the lack of parental or custodial consent for elective procedures involving a minor may result in the lack of a binding contract enabling you or the hospital to receive payment for services.
Documentation
A patient’s medical record is often the star witness in any med- ical malpractice lawsuit. The medical record is the one witness whose memory never fades. When you are involved in a law- suit alleging medical malpractice, it can be your best friend, or it can be your worst enemy. Make it your best friend.
Defensive Charting
“If it’s not documented, it didn’t happen.” This adage serves as a good rule of thumb for all caregivers. Professional com- prehensive charting conveys the appearance of professional and comprehensive care—not only to a jury but also to a plaintiff’s attorney who is reviewing records and deciding whether or not to pursue a claim.
Chart notations need not contain overwhelming details to be helpful in the courtroom. A good defensive chart notation contains information that can deflect practical and obvious criticisms that may be made of the healthcare team or the
writer of the note. Examples of concepts to consider inserting, when applicable, include the following:
●Descriptions of bedside visits, especially when the physi- cian has been paged multiple times
●When you were with the patient and what you did
●Your thought process and differential diagnosis
●Presence of family members
●“Patient states that she understands a change in bowel habits should be reported”
●“Patient refuses colonoscopy because . . .”
●“Patient not able to perform fecal occult blood test because . . .”
Etiology Speculation
The charting of speculative opinions can be as damaging as charting too little information. Not uncommonly, one member of the medical team speculates as to the etiology of an adverse event, and the speculated etiology is adopted as fact by other members of the healthcare team.
Example: Physician undertakes a second-look laparotomy to rule out recurrence of cancer. During the procedure, the bladder and bowl are perforated, but the perforations are identified and repaired intraoper- atively. A bowel leak, however, is detected 3 days later. A second- year resident records in the medical chart, “Iatrogenic perforation resulting in sepsis.” This reference is repeated by two attendings on other services.
The perforation may have been iatrogenic or spontaneous.
The unconfirmed presumption in the medical chart that the bowel leak occurred during the procedure, when repeated by others in the medical record, often becomes a “reality.” That
“reality” may become insurmountable in the courtroom, even when expert review leads to the opinion that the perforation, in retrospect, was clearly spontaneous.
Everything written in the medical chart is critical. Key phrasing and excerpts are often highlighted and/or enlarged onto exhibit boards for juries to see. Remember that causation is one of the four elements of medical malpractice, and it is frequently the most difficult of the four elements for the plain- tiff to prove.
● ALERT!—Iatrogenic means “caused by manner or action of physician, not by medical treatment.” Use this word only when you are sure it is applicable.
The law does not require that physicians always be correct in their decisions and treatment of patients. Rather, it requires reasonable and prudent care. A good chart notation will reflect a physician’s attention and thought process, even if the diagnosis turns out to be incorrect.
Plaintiff’s Preclaim Review
Plaintiffs’ attorneys are usually paid on a contingency fee basis, i.e., they receive a percentage of the amount recovered.
Experienced plaintiffs’ attorneys conduct a review of a
potential client’s medical records before agreeing to file a lawsuit. Because most medical malpractice cases are tried before juries (as opposed to judges), attorneys representing patients look for flaws in medical record documentation that can be exploited at trial. For example, a physician’s criticism of a colleague in a medical record is more desirable to show- case before a jury than complicated medical facts. Although differences of opinion are expected to occur occasionally, conflicts with colleagues that appear in the medical records are best limited to honest disagreements that are relevant to a patient’s course of care.
Other items that attorneys and their reviewing physicians look for are missing laboratory reports, missing radiology interpretations, or the results of any tests or procedures that were ordered but not present in the chart. Multiple page attempts by the nursing staff that go unanswered are also fertile ground for review and focus.
Example: Elderly male patient with debilitating back pain underwent spinal surgery. He was taking anticoagulation medications because of a mechanical heart valve. Postoperatively he developed a hematoma at the base of the spine. In response to complaints of pain, he was seen three times by a house officer who did perform appro- priate examinations but who neither stopped the patient’s heparin nor ordered a magnetic resonance imaging. Permanent paralysis and urinary and sexual loss ensued.
A plaintiff’s lawyer would be immediately drawn to nursing notes stating that multiple page attempts were made and that no corresponding notes were made by any physician respond- ing to the pages. The attorney may immediately assume that he or she can prove in the courtroom one of the following potential scenarios: 1) no physician ever responded to the pages; 2) a physician did respond but the response was not timely; or 3) a physician responded but did not conduct a proper examination.
In this example, a comprehensive chart notation by the house officer, reflecting the thought processes and the extent of the examinations, may obviate a claim, a verdict, and tens of thousands of dollars in legal fees.
Record Tampering and Deception
Improper alteration of the medical record is grounds for puni- tive damages and may result in loss of licensure. It should never be done. Postevent recording in a medical record should be done with proper disclosure of the timing and reason for the entry. Consider seeking the advice of risk-management personnel or legal counsel before making such an entry.
Remember that your medical records are copied for multiple reasons, including insurance, compliance, and quality-review issues. Copies of any given patient’s medical records may exist elsewhere, even at other healthcare facilities.
Plaintiffs’ attorneys routinely request copies of the same medical records from multiple sources. This is done to ensure that all records are gathered, and to determine whether dis- crepancies exist among the various copies, e.g., a late entry on
one copy that does not appear on another copy. Color copying and expert document and handwriting analysis are techniques used to detect late or inappropriate entries. Evidence that a physician intentionally altered a medical record to lessen his or her own liability in a malpractice case is devastating and can rarely be overcome.
Similarly, evidence that a surgical error was known to the physician but concealed from the patient would almost certainly flame juror anger and result in a significant adverse verdict. Sponges, needles, and other “foreign objects” inadver- tently left behind in the patient during surgery and later discov- ered by X-ray should be immediately disclosed to patients. The following 2003 Maryland case16illustrates this point.
The plaintiff, a 49-year-old married grocer, with a long his- tory of uncontrolled diarrhea and stomach pain diagnosed as ulcerous colitis, presented to a colorectal surgeon for a total proctocolectomy with a temporary ileostomy. The surgeon performed ileostomy closure 90 days later, but the patient experienced a return of her uncontrolled diarrhea and stomach pain. She sought the advice of another physician, who discov- ered via colonoscopy that half of her rectum remained after the proctocolectomy. A new surgeon performed a second procto- colectomy and removed the remaining portion of the rectum, after which the patient made a full recovery. The plaintiff’s attorney asserted that, although the first surgeon’s medical notes indicated that he had incorrectly performed the proce- dure, the surgeon failed to so inform his patient. The defendant surgeon contended that it was an acceptable practice to leave half of the rectum. Plaintiff’s medical expenses were $ 51,438.
After experts testified for both plaintiff and defendant, the jury deliberated for only 1.5 hours before returning a verdict for the woman and her husband in the amount of $ 591,438. The award of such a significant sum on these facts in such a short time suggests that the jury was angered by the facts.
Computerized Medical Records
Electronic medical records offer efficiencies and improved medical quality for the healthcare delivery system. All patient records, whether paper or electronic, are discoverable and admissible in medical malpractice lawsuits. Physicians who record entries in computerized medical records must become familiar with the use of electronic medical systems and should understand some dangers inherent in these computer- ized systems. For example:
●BEWARE drop-down menus and checklists
●BEWARE prefabricated medical descriptors
●BEWARE prefabricated informed consent notations
●BEWARE easy click-on techniques
Not all patient evaluations and regimens can be preformatted.
There may be a natural tendency for caregivers to pick the
“closest” option in a menu of options as opposed to creating their own text. Physicians should use “free text” whenever necessary and appropriate. It is easier to explain and defend
“your own words” in describing the care of a patient than the words of a computer programmer who has written a menu of typical patient diagnoses in drop-down menus or other coded formats.
Communication
Adverse Events, Bad News, and Apologies
When an untoward and/or unexpected event occurs involving a patient, communication is critical for quality care and for responding to later claims of malpractice. First and foremost, the patient’s medical needs must be promptly addressed.
Coordination of ongoing care, including consultation and appropriate follow-up, is a critical first step.
As soon as practicable after the event, the patient and fam- ily should be informed of the event and its potential conse- quences to the patient. This communication should be respectful and sympathetic. The discussion should be prelim- inary to a more detailed conversation that should occur after more facts are available. Without assigning blame or criticiz- ing other practitioners, the patient and family should be informed that the event occurred, the current and future con- sequences of the event to the patient, and what steps have been taken to address the patient’s medical condition. If the underlying causes for the event are not yet known, care should be taken not to speculate about those causes. The conversation is best handled by a physician well known to the patient and family, although circumstances may warrant placing others in that role. Questions should be honestly and factually answered. The patient and family should be told that addi- tional information will be conveyed to them as it becomes known, and that a more thorough discussion will occur within a set period of time, ideally 24 hours.
It is usually advisable to contact a risk manager or in-house legal counsel, if applicable, when the critical incident occurs in an institution where such personnel are available.
Depending on institutional policy, risk managers or quality management personnel frequently assist in the interactions with patients and family. They will also begin any appropriate administrative activity, such as initiating a sentinel event analysis, notifying an insurance carrier, sequestering medical devices or equipment, initiating an equipment analysis, and reporting device failures to the United States Food and Drug Administration (FDA). The administrative staff may also wish to convene a risk management and/or quality manage- ment review. Such reviews are typically protected from dis- covery in a lawsuit under applicable state privilege statutes. It is advisable for one member of the institutional team to be designated as the liaison with the patient and family so that consistent information is being delivered.
When additional facts are gathered and a better under- standing of the event is known, a family meeting is advisable.
Ideally the meeting should occur within 24 hours of the initial
discussion with the family. The spokesperson should lead the discussion. The patient’s attending physician, if not the spokesperson, should be present. The information known about the event, the anticipated medical consequences, and the prognosis for the patient should be discussed.
Physicians and institutions should be willing to express sympathy. An apology expressing sorrow that the patient experienced the event may be appropriate but should be care- fully worded, e.g., “We are sorry you have experienced this complication.” In recent years, a number of prominent insti- tutions have urged their physicians to say they are sorry for a patient mishap. One reason is that such apologies may deflect lawsuits. States such as Colorado, Oregon, and Ohio have even enacted legislation immunizing various forms of apolo- gies from courtroom use.17 Advice should be sought from institutional or local legal counsel regarding the wording of any apologetic statements.
At family meetings, the family members should have an opportunity to ask all of their questions. They should be pro- vided with the name and contact information of someone to address additional questions that may arise later. The healthcare team should anticipate questions about reducing or eliminating medical bills and statements suggesting the possibility of a mal- practice claim. Any questions about malpractice can be deferred at that point with the explanation that institutional legal counsel or an insurance representative will contact the family if desired. Keeping in touch with the patient and family spokesperson is critical during the next several days and weeks.
A senior member of the medical team, perhaps with the assistance of risk management and/or legal counsel, should be consulted in reviewing the chart and recording the events involving the untoward incident. Details of the event and the identity of personnel should be completely and accurately recorded. All discussions with the patient and family mem- bers after the incident should also be clearly described, including the identity of persons present at the family meetings and what was said.
Many patients and family members at this juncture are con- sidering whether to seek the advice of a lawyer, and they may be urged to do so by friends and other family members. Care should be taken by all members of the healthcare team to pro- vide a courteous, qualitative, and sympathetic continuity of care and interaction with family members. Physicians and other members of the healthcare team serve themselves and their patients well by using this time to provide as positive and supportive of an experience as possible for patients and family members.
Electronic Mail
Because of the efficiencies associated with electronic mail (email) communication, many physicians communicate with both patients and other healthcare providers by using email.
Special care should be taken when using email that contains patient-identifiable information.
Clinicians may communicate with other clinicians and patients by email. The Federal Health Insurance Portability and Accountability Act (HIPAA) of 199618 (discussed later) pro- vides regulation for electronic transmission containing protected health information such as confidential medical information.
HIPAA provides that healthcare providers have in place appro- priate administrative, technical, and physical safeguards to pro- tect the privacy of protected health information (PHI).19The HIPAA regulations do not provide a specific regulatory scheme for email communication, but they do require that providers have procedures that limit disclosures of PHI to the amount rea- sonably necessary to achieve the purposes of PHI disclosures.20 The Notice of Privacy Practices that providers give to their patients must explain in a separate statement that the provider may contact the patient to provide appointment reminders or information about treatment alternatives or other health- related benefits or services that may be of interest to the indi- vidual.21If this will be done by email, it is advisable to state that in the Notice of Privacy Practices.
You may wish to inform your patients that email transmis- sion involves privacy and security issues that may be of inter- est to them. Patients may even be asked whether they wish you to communicate with them by email or not. Email that is sent to a patient’s business may be intercepted by the patient’s business colleagues, and emails can be inadvertently trans- mitted to unintended addressees. The Internet is not con- sidered a secure medium for transmitting confidential data unless both parties use encryption technology. These types of warnings can be provided to patients who wish to communi- cate with their physicians by email.
It is advisable for physicians to keep either paper or elec- tronic copies of emails to and from patients that are relevant to patient treatment. These email copies should be maintained in the patient’s medical records just as traditional paper cor- respondence would be.
Physicians may wish to include a Confidentiality Notice that is preprinted at the bottom of email transmissions. A sam- ple Confidentiality Notice appears below:
Confidentiality Notice: This email message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unau- thorized review, use, disclosure, or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message. If you are the intended recipient, but do not wish to receive communications through this medium, please so advise the sender immediately.
Health Insurance Portability and Accountability Act
HIPAA provides national privacy protection for patients.
Administrative Regulations, encompassed in the Federal Privacy Rule22have been promulgated by the United States Department of Health and Human Services pursuant to
HIPAA. The Federal Privacy Rule establishes minimum pri- vacy standards for healthcare providers, health plans, and healthcare clearing houses (referred to in HIPAA as “covered entities”) to follow when using and disclosing patient-identi- fiable PHI that they create or maintain. Generally speaking, PHI is any information that is created (or received) and main- tained by a covered entity related to the health or health care of a patient (or payment related to the health care) that directly or indirectly identifies the patient.23
The Federal Privacy Rule also requires compliance with state laws that afford greater privacy protections than HIPAA.
Compliance with the Federal Privacy Rule was required on and after April 14, 2003. All covered entities must have poli- cies and procedures in place that demonstrate compliance with the Federal Privacy Rule.
HIPAA provides that healthcare providers must make a good faith effort to give each patient a Notice of Privacy Practices that describes the privacy practices of the healthcare provider.
Patients must be asked to acknowledge in writing that they have received this notice. Once a provider makes a good faith effort to provide a Notice of Privacy Practices to a patient and gets the patient’s written acknowledgement of receipt of the notice, the healthcare provider may use and disclose PHI for reasons related to treatment of the patient, payment for the patient’s health care, and the healthcare operations of the provider (TPO). Generally, physicians who are independent practition- ers of the hospitals of which they practice are part of those hos- pitals’ “organized health care arrangements,” enabling the disclosure of PHI between the hospital personnel and the inde- pendently practicing physicians. To use or disclose PHI for rea- sons other than TPO or as otherwise permitted by law, a physician must obtain an additional written permission from the patient called an “authorization.”24Clinical research, for example, is not considered “treatment” and usually must be separately approved by research subjects by signing an author- ization. In many medical centers, authorizations for clinical research are integrated into the consent form approved by the institutional review board (IRB). The Federal Privacy Rule requires that authorizations contain certain elements.25
HIPAA permits treating physicians to disclose to a patient’s family members, other relatives, close personal friends, and others identified by the patient any PHI that is directly rele- vant to such person’s involvement with the patient’s care or healthcare payments. Before making any of these disclosures, a physician should either obtain the patient’s agreement to the disclosure or reasonably infer from the circumstances that the patient does not object.26
Research and Innovative Surgery
Research Versus Innovative practice
The emergence of evidence-based medicine has brought new challenges to the academic medical community. Surgeons and other physicians who serve as investigators in clinical trials
are very familiar with the review and approval process of IRBs—ethics committees established under federal law to oversee the conduct of research. Many disciplines, especially surgery, have evolved historically in an environment of unreg- ulated innovation. It is often not clear when innovative ther- apy crosses the line into the research arena.
The Belmont Report27states that the distinction between research and practice is blurred and that both often occur together. Research is usually described in a formal protocol, and departures from standard practice are not necessarily
“research.” The Belmont Report also states:
The fact that a procedure is “experimental,” in the sense of new, untested, or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.
Regulation of the practice of medicine has historically been the exclusive province of the state medical boards and other state regulatory authorities. When medical practice crosses the line into “research” involving “human subjects” or inves- tigational drugs, devices, or other test articles, however, the activity becomes subject to the regulation of the federal Office for Human Research Protection (OHRP)28 or the FDA.29
“Research,” as regulated, is a systematic investigation, includ- ing research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.30“Human subjects” are living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private informa- tion.31 Traditional examples of research studies include prospective industry-sponsored files.
Database Registries
In theory, physicians who engage in innovative treatment that does not involve a systematic design, a research protocol, a prospective intent to publish, or an investigational item are not regulated by either OHRP or FDA. Over the past decade, however, OHRP has expressed its view that the systematic collections of data performed off-chart, especially if pub- lished, may carry an implicit prospective intent and are con- sidered research. These may include ongoing patient registries, including outcomes data; tissue banks; static data- bases, including ad hoc research from closed trials; and even retrospective studies, including chart reviews, if a prospective intent to publish was present.
In recent years, the OHRP has investigated a variety of innovative techniques to determine whether or not the activ- ities should have been prospectively reviewed by an IRB as research. Examples are: 14 patients treated with fractionated stereotactic radiosurgery for treatment of large arteriovenous
malformations before IRB approval32; publication of a retro- spective chart review that was conducted without IRB approval33; publication describing partial left ventriculec- tomies performed in the management of patients with dilated cardiomyopathy without IRB approval34; and fetal surgery procedures.35Many if not all of these scenarios involved pub- lications that used research jargon and implied that a prospective research trial had been conducted (without IRB review and approval). In each of these investigations, OHRP suggested that the applicable institution consider the devel- opment of “innovative practice committees” or similar insti- tutional vehicles to evaluate major innovative therapies.
Physicians, especially surgeons experimenting with minor surgical modifications to accepted techniques, should use care when authoring articles about clinical experiences that did not involve “research” as defined above. When in doubt, physicians are encouraged to consult with their local IRBs for guidance.
Promotional Prohibitions
Physicians who conduct FDA-regulated research are prohib- ited from representing in a promotional context that an inves- tigational new drug, device, or other test article is safe or effective (or otherwise beneficial) before it has received reg- ulatory approval.36Physicians should carefully review press releases and other promotional disclosures prepared by com- mercial sponsors or manufacturers before permitting their names to be associated with such test articles before approval.
Insider Trading
If you are involved in clinical trials for pharmaceutical com- panies or biotechnology companies whose securities are pub- licly traded, you may have certain obligations to protect the confidentiality of sensitive information that you acquire. Your duties may stem from not only being a company officer or holding another fiduciary position, but also from being an investigator or from serving on company advisory committees such as scientific advisory boards, clinical trial steering com- mittees, clinical trial executive committees, or data safety monitoring boards. The securities laws widely prohibit fraud- ulent activities of any kind in connection with the offer, pur- chase, or sale of securities.37The securities laws are the basis for different types of government enforcement activities, including investigation involving illegal insider trading.
Insider trading is illegal when a person trades a security while in possession of material, nonpublic information, possibly including information from medical research trials, in viola- tion of a duty to withhold the information or refrain from trad- ing in that security. “Tipping” other traders of such information who then trade a security affected by the tip is also illegal. So is acting on an illegal tip.
Conclusion
In recent years, the demands and pressures on physicians and surgeons have grown dramatically. Lawyer advertising and malpractice awards and settlements are greater than ever before. Web-based consumer awareness has increased the knowledge base of patients. Government regulation and enforcement activities have become more focused. Greater understanding and awareness of legal and risk management concerns is critical for healthcare practitioners facing these challenges.
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