Lessons Learned: Implementing a Digital Process for Informed Consent

Patient Safety Monitor Insider

November 4, 2015

 The modern concept of informed consent was born barely a century ago in Schloendorff v. Society of New York Hospital—a 1914 case establishing that procedures performed on a person without the patient’s explicit permission are a form of battery. The notion that risks and alternatives must be disclosed to a patient was established in 1957 in Salgo v. Leland Stanford Jr. University Board of Trustees. That idea was further refined in 1972 in Canterbury v. Spence to specify that the risks disclosed should include those that a reasonable patient might want to know.

Today, the requirements for informed consent are spelled out in statute and case law in all 50 states. Typically, states fall into one of two major groups when it comes to how much information should be disclosed to patients as part of the informed consent process (Select state law provisions, n.d.; Studdert et al., 2007):

  • Professional standard: Roughly 23 states, including New York and Florida, require that patients be presented with the information that would be communicated by other physicians with similar background and experience and practicing within their community
  • Patient standard: Another approximately 23 states, including Ohio and Texas, require that patients be presented with the information that a reasonable or prudent patient would want to know in order to make a decision about a treatment or procedure

A handful of states employ laws that blend aspects of the patient and professional standards, resulting in a “hybrid” standard for disclosure. In all cases, however, informed consent involves much more than merely signing a document. When done properly, it is a conversation between provider and patient that is documented in a consistent manner as part of the medical record.

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