for DR.SAMUELSON only!!!!

MHCM 6320 Corporate Compliance and Legal Issues in Healthcare

Chapter 5: Compliance Patient Consent

Week 4 Lecture Notes

The internet has provided incredible access to medical information to the public. Not

only may one access his/her own medical information on-line, but one may also

research diseases, diagnoses, drug actions and interactions, and carry out extensive

research in furtherance of an understanding of the need and efficacy for health care. As

a result, it is necessary that providers be knowledgeable regarding issues surrounding

patient consent.

Early on, the medical community resisted the idea of allowing patients to participate in

decisions regarding their treatment, contending that only those with appropriate medical

training were competent to make such decisions. However, as the law developed

surrounding this issue, it has become clear that those of us who must live with the

results of treatment or non-treatment should be informed and participate in the

decisions regarding that treatment. The Supreme Court of the United States has ruled

that the Fourteenth Amendment – the “taking” clause – provides such a right – in

Cruzan v. Director, Missouri Department of Health (1990).

Two forms of consent are recognized, as with many areas of law. The two are “implied”

and “express”. Implied consent exists where the actions and words of a patient clearly

show that the patient was entering into a consensual situation with the provider of care,

while express consent is present where there is a clear expression of consent – either in

writing or orally. Of the two, it is, of course, much clearer – and therefore safer – to

have express consent and for that consent to be in writing in a form and character that

removes any doubt. Thus, the healthcare providers are much better served when they

acquire a prepared form, signed by the patient, designed for the express purpose of

documenting the patient’s consent to the specific treatment or procedure in question.

Another form of express consent is found in “advanced directives”, where the patient

has lost his/her ability to make such decisions, the most common type being a “living

will”. These also sometimes take the form of a “do not resuscitate” (DNR) order, signed

by the patient or responsible party.

Sometimes the need for a “Health Care Surrogate” arises, where the patient is unable to

make decisions and has not provided a living will or DNR order in advance. In such

cases, a “Designation of Health Care Surrogate” or “Durable Power of Attorney for

Health Care” is the form executed by a responsible party.

On the opposite side of the issue of assuring documentation and information availability

is the requirement for confidentiality of information, required by, among other authority,

HIPAA and that such requirements be published in the form of Privacy Notices.

While HIPAA allows for the sharing of medical information, it requires strict

confidentiality of any aspect of the information that could be identified or tracked back to

an individual patient. The provider must inform the patient of its privacy practices and

to acquire written acknowledgement by the patient of receipt of this information.

Providers must also inform patients of policies regarding release of any information. It

is best to always acquire specific permission from the patient for any release of such

information.

Finally, the provider should get written acknowledgement of the patient’s consent to

contact, including the desirable and acceptable methods such as: voice mail, email,

regular mail, etc.

Super confidential information may not be released without specific permission unless

required by law.