Right to Privacy and Confidentiality

Right to Privacy and Confidentiality

The 1997 medical ethics guidelines proposed by the National Human Rights Commission debar doctors from sharing a patient’s confidential information for any monetary inducement

The exchange of information between a doctor and patient is always confidential and personal. Confidentiality helps patients to be frank and honest with their physician, which in turn leads to better health outcomes. A good doctor will protect patient privacy, as it helps build trust and bonding between them. The issue of confidentiality needs to be addressed even more urgently with the introduction of electronic medical records, which can be shared easily with the click of a mouse. Although the electronic exchange of health information offers significant benefits, it increases the risk of inadvertently exposing private medical information.

The meaning of confidentiality

Because patients share so much sensitive, private and personal information with their doctor, the duty to maintain confidentiality has been enshrined in the Hippocratic Oath. The International Code of Medical Ethics states that “A physician shall preserve absolute confidentiality about all he knows about his patient, even after his patient has died.”

As per the Medical Council of India Code of Ethics Section Clause 7.14, “The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his/her profession except –

i) In a court of law under orders of the Presiding Judge;

ii) In circumstances where there is a serious and identified risk to a specific person and/or community; and

iii) Notifiable diseases. It is his duty that he should inform public health authorities immediately about any communicable or notifiable disease. “

Of course, matters become more complex when there is a conflict between the right to privacy and the right to health of another individual.

Ideally, information about a patient’s records should not be released to anyone outside of the hospital without the patient’s authorization, unless it’s being shared with another healthcare facility to which the patient is being transferred, or if the release has been ordered by a court. If this is being done under a third-party payment contract for research work on aggregated statistics, information sharing is permissible, provided the patient’s identity is masked.

When software engineer, Abdul Mustafa (name changed) tested HIV-positive, he did not want his employers or his friends to know about it. Had the doctor still gone ahead and divulged this information, it would have amounted to a breach of trust and the confidentiality proviso. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the USDA made several sweeping changes relating to privacy and confidentiality of medical records. It established privacy procedures, the need to inform patients about these procedures; the need to train employees to follow strict privacy guidelines, and the importance of designating an individual to oversee the healthcare organisation’s privacy initiatives. In India, where such laws don’t exist, it’s important that patients seek the help of patient-advocates in securing their right to privacy and confidentiality.

Shh….A Patient Has the Right to Confidentiality Patients need to be confident that the doctor will protect their confidentiality. Thus, if you don’t want your psychiatrist or your infertility consultant to call your secretary to leave a reminder about your next appointment, please make this request in writing.

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Right to Simplified Information

Advocates can assist healthcare professions in providing culturally-competent care to patients

Imagine lying on a hospital bed - anxious, uncomfortable, waiting for test results and fearing the worst. Now imagine being probed in all the sore places by unconcerned doctors and nurses who wear deadpan expressions as they stop by to take your vital signs, do blood tests, and listen to your chest. Also imagine that the hospital that you have landed up in is in some remote corner of Africa, and you don’t have a clue what the medical staff is saying, and you cannot explain what you are feeling. This is often how poor, uneducated, illiterate patients feel when they find themselves in a large hospital in the city, where everything is unfamiliar and threatening.

The reasons for healthcare disparities

Some factors that contribute to health disparities are:

                Persistence of centuries-old racial stereotypes

                Time pressures caused by increasing case loads

                Lack of decision-making skills in the junior health care staff

                Absence of a patient-advocate in the picture

Real or perceived discrimination in hospitals can lead minorities and the poor to mistrust doctors and nurses. The onus is on the healthcare provider, who is the “more powerful actor in clinical encounters” to see to it that such disparities do not occur, and if he fails in this duty, it’s the patient-advocate’s responsibility to step in and correct matters.

In a recent survey, physicians reported that more than half of their patients do not follow medical treatment as a result of cultural or linguistic barriers. While the majority of doctors surveyed agree that language and culture are important in the delivery of care to patients, only half of the doctors reported having any form of “cultural competency training.” This lacuna is one which a caring patient advocate can fill competently, allowing him to act as a bridge between the doctor and the patient.

The need for cultural competence in patient-advocates

Cultural competence leads to cultural awareness, knowledge, understanding, sensitivity, interaction, and skill. It necessarily flows from good “communication.” Efficient health care delivery also depends upon health literacy, which varies between different cultural groups.

Although poor health literacy can be a particularly thorny problem in patients with low literacy skills, it can also affect patients who think of themselves as being literate. Even doctors sometimes find it hard to make sense of the convoluted language which health insurance companies and hospital administrators use in their forms. A patient advocate can help in decoding this medical jargon.

Lay theories of anatomy and physiology can also influence how people interpret and respond to their illness. In Indian villages, women often describe their menstrual blood as “bad” or “toxic”, and are forbidden from entering temples or even their kitchens, when they are menstruating. It is hardly surprising that they have a hard time describing their gynaecological problems to doctors. The presence of an advocate can help transcend such cultural and linguistic barriers.

The Right to Informed Consent in a Clinical Trial

A patient participating in a clinical trial has the right to know all the information regarding the trial, including its potential benefits and risks, so that he can make an informed decision

Clinical trials are scientific research experiments, conducted on human volunteers in order to find new ways to prevent, detect and cure diseases. Medical science has grown leaps and bounds on the back of such biomedical research. When done properly, such studies are very useful in improving our medical knowledge base.

However, not all clinical trials are conducted ethically. This is especially true in India, which is fast becoming an attractive destination for carrying out clinical trials, primarily because we have a huge and diverse pool of patients on whom these trials can be conducted fairly inexpensively. Many of the patients chosen are uneducated, who can easily be exploited by doctors, researchers and pharmaceutical companies, alike. Unethical researchers (who get paid huge sums for signing up as many participants as possible) may exaggerate the benefits of a treatment, offer financial sweeteners, or attempt to play down the risks of the trial.

In 1997, the oncology division of the Indian Council of Medical Research (ICMR) carried out an observational study on cervical cancer in Indian women. The study did not have any ethical clearance from the All India Institute of Medical Sciences (AIIMS) from where the subjects were drawn; nor did the researchers get informed consent from the subjects themselves. Under the ICMR study, 1100 uneducated urban women from Delhi with pre-cancerous lesions were studied between 1976 and 1988. The objective was to study the natural progression of cervical dysplasia to cervical cancer (the most prevalent cancer amongst Indian women) without any medical intervention. So despite the fact that a simple surgery would have removed the cervical lesions, before they could turn cancerous, the women were wantonly left untreated. The outcome was that 62 of these women needlessly developed cancer; and in nine the disease had already spread to other parts of their body.

In another equally scandalous incident, an Indian scientist attempted to inject the bovine HIV strain into a human subject. This research was also not approved by any ethical body. Likewise there have been reports of a pig’s heart transplant into humans; and controversial trials with mepacrine, an anti-malarial drug that is injected into a woman’s uterus for contraceptive purposes, although some doctors suspect it causes cancer. Although every hospital unit is supposed to have its own ethical committee, in our country most are defunct bodies. The National Human Rights Commission (NHRC) guidelines propose that a research group must provide human subjects with printed literature, explaining in simple, non-technical language, the purpose of the study; details of the procedure; the risks involved; the financial or other interests of the researcher; and a commitment to treat, completely and free-of-cost, any complication that may arise during the course of the trial.

The subject too has to certify in writing that she has understood the document and is volunteering to participate in the research, without the promise of any monetary inducement that is not permitted under the Indian law. There are a few other government bodies that monitor clinical trials such as the Drug Controller of India and the Clinical Trial Registry in India (CTRI). Nonetheless, the Supreme Court recently expressed reservations about the unethical way in which most clinical trials are being conducted in the country, and has directed the Ministry of Health to formulate proper guidelines on this, to protect patients’ interests. According to existing rules, an ethically sound clinical trial:

                Will aim for the enhancement of medical knowledge

                Will have strong scientific validity

                Will recruit participants fairly

                Will have a favourable risk-benefit ratio

                Will have people who independently review, approve, amend or terminate it

                Will obtain informed consent from its participants

                Will respect the participants privacy and will strive hard to protect their wellness and rights

Role of patient advocates in clinical trials

Patient-advocates can play an extremely important role in clinical trials. Among other things they are required to:

                Make sure whether the information about the trial is presented in a format which is easily understandable to the patient

                Assist the research team in developing relevant educational materials about the trial in lay-friendly terms that is simple and easy to understand

                Identify and address potential ethical issues in the trial

                Promote patient safety and confidentiality

                Assist the research team in obtaining valid informed consent from the patients, recruited in the trial

QUIZ TIME: Informed Consent Quality Assessment Questionnaire

Use this form to gauge patient’s understanding of their participation in clinical trials

                Do you feel that you have been informed how long your participation in this clinical trial will last?

                Do you think that all the treatments and procedures that the investigator proposed for you are the best for your disease?

                Do you understand what “randomisation” means?

                Do you know that no direct medical benefit will derive to you from your participation in this clinical trial?

                Are you sure that your participation in this trial will not involve any additional risk or discomforts?

                Do you know that because you are participating in a clinical trial, it is possible that the study sponsor, various government agencies, or others not directly involved in your health care could have access to your medical records?

                Do you know that the consent form you signed lists the names of the contact persons, who must answer any of your questions or concerns about the clinical trial?

                Do you know that the consent form you signed describes how you will be covered by insurance if you are injured or become ill as a result of participation in the clinical trial?

                Do you understand that if you do not want to participate in the clinical trial you are free to refuse to sign the consent form? This will not affect the quality of medical care you receive, so you do not need to be scared that your doctor will get angry or upset if you refuse to participate.

                Do you understand that you are not obliged to remain in the clinical trial if you decide to withdraw at any point of time?

                Explain in your words the purpose of the clinical trial to which you have consented to be a subject.

A patient-advocate who uses such questionnaires with patients who have been recruited to participate in a clinical trial will help to protect the patients; and will also ensure that the research team is never caught on the wrong side of the fence.

Right to Full Disclosure and Information

A patient has the right to know why a test is needed; what the expected results are; how much it costs; and how it can change her treatment options

Sample these reported cases reported in the media:

In October 1989, Zairunnisa Parekh got admitted for treatment of a tiny 1-cm stone in her kidney at Jaslok Hospital, Mumbai. She died 35 days later of peritonitis. Her husband Yusuf and son Mushtaq filed a case of negligence against the doctors, stating that the hospital denied them a copy of her medical records.

In another such case, Bhagwati Raheja died after a by-pass surgery at Mumbai’s Nanavati Hospital. The deceased’s husband maintained he was refused a copy of his wife’s medical records.

On 11 July 2001, Sandhya Karmakar, 36, mother of a ten-year-old boy, died at the SSKM hospital in Kolkata. She had been admitted for appendectomy on 26 June. The surgery went fine, but a surgical mop was ‘inadvertently’ left behind in her abdomen. Surgeon M L Shaha had to perform a second surgery to remedy the error on July 3. A leakage developed and to fix that, a third surgery had to be done on July 7. It was later discovered that the doctor who had performed the appendectomy had left the entire post-operative process, including suturing the wound, to his nursing staff.

In these, and several other such cases, patients or their families had to seek intervention from the Courts in order simply to access their medical records - documents that were legally their property. When complications occur, hospitals invariably deny wrong-doing and the onus shifts to the patient’s family to prove that what went wrong was a result of the doctor’s or the hospital’s negligence. Without concrete evidence in their possession, this can Patients and their families often complain that a particular doctor is keeping them in the dark about the diagnosis or prognosis of a disease. A busy doctor, walking away from anxious relatives with nothing more than a pat on the shoulder (and sometimes not even that), is unfortunately a very common sight in our hospitals. Patients commonly complain that a physician orders a battery of tests or procedures, without explaining why they are needed, how much would they cost; what results are expected; and how these would affect their line of treatment. When this basic information is not readily forthcoming, the outcome can be frustration that leads to growing discontent with the doctor and the hospital.

The reporting of several incidents of medical negligence and subsequent cover-up attempts by hospitals and doctors have resulted in patients being better informed about their legal rights. Patients are now demanding a more transparent and accountable doctor-patient relationship. According to a Supreme Court directive, patients and their relatives have the right to be informed and this consent is meant to educate the patient, not be almost impossible.

Patients and their families often complain that a particular doctor is keeping them in the dark about the diagnosis or prognosis of a disease. A busy doctor, walking away from anxious relatives with nothing more than a pat on the shoulder (and sometimes not even that), is unfortunately a very common sight in our hospitals. Patients commonly complain that a physician orders a battery of tests or procedures, without explaining why they are needed, how much would they cost; what results are expected; and how these would affect their line of treatment. When this basic information is not readily forthcoming, the outcome can be frustration that leads to growing discontent with the doctor and the hospital.

The reporting of several incidents of medical negligence and subsequent cover-up attempts by hospitals and doctors have resulted in patients being better informed about their legal rights. Patients are now demanding a more transparent and accountable doctor-patient relationship. According to a Supreme Court directive, patients and their relatives have the right to be informed and this consent is meant to educate the patient, not just protect the doctor and hospital. Merely asking the patient to sign a piece of paper thrust in front of him by a nurse on his way to the Operation Theater will not serve the purpose.

Patient-advocates can help doctors to build a rapport with the patient, so that there can be a full and frank discussion of the risks and uncertainties which are inherent in any medical treatment.

The Truth, the Whole Truth, and Nothing but Truth… Sometimes, withholding the harsh truth from the patient is not a result of medical paternalism, but arises out of the doctor’s sincere desire to protect the patient from emotional distress.. It’s not always easy for a doctor to know how much truth the patient can tolerate and this can create a dilemma for the doctor, as the following story, “The doctor’s word” by R K Narayan illustrates: Dr. Raman diagnoses his close friend to be critically ill. The doctor knows that the patient has a good chance of recovery if his condition does not deteriorate during the night. Now the ethical dilemma confronting Dr Raman is - should he tell the patient the truth about his dire prognosis, or should be wait until the next morning? The patient has already expressed his wish to write a will. The good doctor is in a fix. He resolves it by deciding to deceive the patient, and tells him that he can easily write the will the next morning, since there is no urgency. The patient is relieved, and survives What is the moral of the story? The doctor needs to use his judgment as to whether or not to disclose information that has the potential to harm the patient