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INTERNET MEDICINE:
"So, I think I'm ready...what are the Risks?"

By Dan Groszkruger, JD , MPH, Editor and
Waldene Drake, RN, MBA, Vice President, Risk Management

Does Internet Medicine create legal risks?
It could, and probably does! But, uncertainty prevails, as the laws governing on-line activities continue to change and to evolve. The extent of any increased risk will probably depend mainly upon the purpose and the use of your Web Site. Cautious physicians may include only their photographs, biographical sketches, their medical specialties, office address (with directions), and eligible health plans. But, some physicians are considering one of the following:

• Educational Site: Web Sites that provide general health and medical information, coupled with custom disclaimers, probably pose the least risk. For example, Dr. A. places his own materials and publications on his Web Site to reinforce his in-office patient teaching. During an office visit, Dr. A. provides his patients with his Internet address, suggesting that patients review the material later, at their convenience. Dr. A. also includes hyperlinks to reputable sources of health information, such as medical professional groups (A.M.A., etc.) and disease advocacy and support groups (e.g., heart, cancer and stroke). Dr. A.'s Web Site includes this disclaimer: "This information is offered solely for purposes of general patient education, and may not be relied upon as a substitute for professional medical care. Consult your own physician for evaluation and treatment of your specific condition."

• Interactive / Marketing Site: Web Sites designed to attract new patients give rise to more serious risks, particularly if patients are invited to share confidential information and to rely upon your on-line feedback. An unintended physician-patient relationship may arise. For example, Dr. B., an internist, designs a Web Site to market his practice. Patients are invited to fill out questionnaires, on-line, and to ask questions about health or medical care. Dr. B. and his staff provide responses to these questions by e-mail, free-of-charge. In addition, patients can make appointments to see Dr. B. in his office. And, they can order health or nutrition publications by mail, using a credit card. Finally, Dr. B. provides referral services to surgeons and other specialists, for those patients who may need specialized medical care.

  This type of Web Site carries substantial risks, since patients receive feedback that could be interpreted as personal medical advice, without having been seen by the physician. To illustrate the point, California law requires a "good faith examination," conducted by a physician, prior to prescribing any "dangerous" drug.¹ The California Attorney General (according to newspaper accounts) assumes that any prescription drug is potentially "dangerous" and that the "good faith examination" requirement cannot be satisfied over the Internet. ²

Depending on their content, physicians' Web Sites raise further issues:

• Licensing: The Internet observes no political or geographic boundaries. But, the practice of medicine is controlled by laws and regulations unique to each State. While physician-to-physician consultations across state lines are generally exempt, there is no similar exception for physician-patient encounters. Most state medical boards require a physician who plans to treat residents of that state to comply with its state licensure rules. While some states have adopted licensure procedures for out-of-state physicians who only provide services via electronic media, most states have no such laws. In every state, practicing medicine without a license is a criminal offense. Also, out-of-state physicians face exposure to malpractice lawsuits under unfamiliar standards of care (and for California physicians, without any limits on pain & suffering or punitive damages, as California's MICRA imposes). The MPT Agreement excludes coverage for out-of-state medical practice.

• Kickbacks and Self-Referral: Federal anti-kickback laws and prohibitions against self-referral may apply to Internet transactions. For example, a physician who uses his Web Site to refer patients to a business that he owns may run afoul of federal laws. The Office of the Inspector General (Dept. of HHS) has issued just one advisory opinion,³ concluding that a telemedicine consultation arrangement "may constitute prohibited remuneration under the anti-kickback statute if the requisite intent is present."

• Privacy and Confidentiality: The Secretary of Health and Human Services recently published draft rules on privacy and confidentiality of electronic medical information (final regulations are not due until February 21, 2000). Telemedicine, by definition, involves transfer of individually-identifiable health information, of the type regulated by new federal regulations. The rules apply to the information itself - not to the document or to the electronic medium where it is stored.

• Informed Consent: The absence of face-to-face encounters makes the process of obtaining the patient's informed consent more difficult. Informed consent requires a dialogue, in which the physician explains both benefits and risks, and the patient has an opportunity to ask questions, before giving consent. Subsequent documentation of the process provides only indirect evidence that the required exchange of information occurred. California law requires documentation of informed consent "prior to...delivery of health care via telemedicine."⁴