Dr. Goldberg is Director of Skin Laser & Surgery Specialists of New York and New Jersey, Director of Mohs Surgery and laser research, Mt. Sinai School of Medicine, and Adjunct Professor of Law, Fordham Law School.
Although the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorized initial grants and incentives to promote “meaningful use” of electronic health records (EHRs) by providers, one of the potential risks that has not been given much discussion is the risk of medical malpractice liability.
If a patient’s procedure uses a device that is not FDA-approved, or is FDA-approved for another purpose, or is experimental, must the patient be so advised by the physician to provide appropriate informed consent? Courts have wrestled with this matter in a number of legal opinions.
Dr. Surgery undertook a weekend blepharoplasty course at a well-respected, nationally recognized occuloplastic surgery program. He has since performed three procedures. Dr. Surgery covered the risks with his patients and received both oral and written consent. His third patient unfortunately suffers the rare complication of retrobulbar hematoma and blindness and sues. Should he be concerned?