Teleradiology: An Underdeveloped Legal Frontier
Tom Hoffman, Associate General Counsel and Bill Shields, General Counsel
Precedent is a lawyer's currency as an image is a radiologist's. The teleradiology arena, however, offers little precedent in the form of statutes, regulations, or judicial decisions to guide attorneys and their radiologist clients. Recently, an ACR task force uncovered more questions than answers. This article will explore the underdeveloped medical-legal frontier of teleradiology, particularly on an international scale, and offer some markers to those who travel it.
Several nighthawk services in the United States and other nations, as well as radiology departments in larger facilities, have filled the gap between 24/7/365 expectations and the capabilities of practices to meet them.
Yet the medical and business aspects of teleradiology have evolved far beyond its legal boundaries. Why? Until new laws are passed, teleradiology must be considered within a traditional legal framework that was never intended to address these technological advances. Current state laws require state licensure, facility credentialing and privileging, and medical liability insurance. Consequently, the most advanced teleradiology model will have to adapt to the time-honored principles of statutory and contract law. Yet, a radiologist who does teleradiology can balance clinical and economic innovation with legal due diligence.
The Liability Threat in Teleradiology
Liability, however, looms as the "Bermuda Triangle" of teleradiology. The threshold question for any radiologist interpreting an image of someone located hundreds, or even thousands, of miles away is whether they will be deemed to have a physician-patient relationship. Although no reported case law exists on this point, the answer is probably "yes" for an official or primary interpretation. Presumably, a court would view the official or primary interpreting radiologist as rendering medical advice for the express purpose of diagnostic and potentially therapeutic care. Conversely, if a radiologist merely offers a second opinion or a consultation, one could argue that there probably is no formal physician-patient relationship. Yet, perhaps such a relationship could be implied. After all, did the radiologist provide a medical service directly to the patient outside the zone of their relationship with a referring physician?1
Assume that a radiologist owes a legal duty to a patient located in another state or country. The next unresolved issue is in what jurisdiction or jurisdictions is the radiologist legally accountable for their interpretation. Does interpreting an MRI of the brain on a patient lying in a New York hospital bring the teleradiologist sitting in Israel under the auspices of New York law? Again, no reported precedent exists on this point. In fact, the ACR Legal Department knows of no lawsuit that specifically involves a teleradiology interpretation. Discussions with private sector attorneys who represent radiologists providing teleradiology services suggest that it might be difficult to enforce any civil judgment that a US court or jury might award against an interpreting physician located in a foreign land. The same is not true for the US hospitals and radiology groups who use these teleradiology services. Injured or misdiagnosed patients will almost certainly seek compensation from the organizations with which they have direct contact here in the United States.
All parties to a teleradiology arrangement absolutely need insurance. They should obtain it through their employer or a contract with another party. From the group's standpoint, it has the main responsibility for organizing the teleradiology interpretation coverage. Therefore, the group should obtain written documentation from the insurance carrier that it is willing to extend insurance coverage for the exact circumstances of the services under contract, with the additional consent to a US jurisdiction for claims resolution. However, the insurance prospects for teleradiology appear mixed. Some radiologists have reported problems getting access to coverage for international teleradiology. The Physician Insurers Association of America companies have little claims experience in the international market. Anecdotally, PIAA officials have indicated they may restrict coverage because they are concerned about uncertain liability risk and perceived quality issues with overseas reads. Therefore, radiologists who interpret abroad need to specify in their contract what entity will cover them and in what jurisdiction any claims will be brought. Moreover, they may have to indemnify or hold the other party–the contracting or employing group–harmless for their acts or omissions.
The Issue of Licensing
Any radiologist who engages in or plans to engage in teleradiology also must deal with state licensure. The relevant question here is whether interpreting images remotely from the transmitting site represents the practice of medicine and requires a license in that site. Generally, most states answer a resounding "yes." For example, Florida and many other states mandate that any radiologist who provides an official or primary interpretation relied on for treating a patient in their jurisdiction is practicing medicine. Consequently, they must apply for and receive a license in the state where the patient is located. These states typically exempt occasional out-of-state interpretations or consultations done as second opinions. Other states, such as Alabama and Oregon, issue "special purpose" licenses that protect radiologists who intend to diagnose patients in those states. Physicians must prove they hold a full and unrestricted license to practice medicine in another state and that they have not had any disciplinary action taken against them. Out-of-state physicians then register with the special purpose state and receive the special purpose license for a specific term of years. Licensure thus is the passport to legal teleradiology. For US groups that deal with out-of-country teleradiologists, it also may provide the strongest jurisdictional leverage.
The Benefits of Credentialing and Privileging
Hospital or facility credentialing and privileging is another significant legal issue for teleradiology. Should a teleradiologist have to secure medical staff privileges and hospital credentials as do their US-based colleagues? Is it reasonable–and fair–to expect that a physician located in Tel Aviv must assume the same staff responsibilities as one in Texas? The ACR believes so.2 Yet many teleradiologists are unaffiliated with a particular hospital and practice independently. As a regulatory matter, only Massachusetts requires hospital credentials for hospital-based teleradiology; other states, however, may follow.
More important, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has focused on telemedicine and teleradiology credentials at hospitals. In 2004, JCAHO issued new standards on telemedicine and contracted services. Designed to help small and rural hospitals obtain sought-after specialty services like radiology, the JCAHO standards have spurred some of these hospitals to contract with nighthawk services. These hospitals have the option of independently verifying the credentials of off-site practitioners and granting them staff privileges, or accepting the contractor's representations regarding the credentials of its physicians. Some hospitals allegedly have used this option to circumvent their medical staff bylaws that establish a uniform credentialing process for providing imaging services. Issues raised by the ACR and others about this "credentialing by proxy" or "by contract" controversy have made JCAHO reconsider the 2 standards. JCAHO has indicated that it welcomes the ACR's input on the significant teleradiology and credentialing issues. The ACR has a representative on the advisory group and continues to closely monitor the standards. Whether a hospital provides teleradiology from within or outside its medical staff, however, the legal burden to perform quality assurance on such teleradiology likely will fall on the institution.
What Risk Management Steps Can Radiologists Take?
First, radiologists should balance their sense of market innovation with legal prudence. They should not act like they are in the "Wild West" of commerce merely because teleradiology is an underdeveloped legal frontier. A few suggestions for radiologists or group practices:
- Conduct due diligence in financial and contractual arrangements with teleradiology companies, hospitals, and other physician groups.
- Seek board-certified, licensed, credentialed, and insured physicians as qualified partners in any teleradiology venture.
- Insist on clear liability provisions in contracts with overseas teleradiologists or companies.
- Watch federal and state legislative efforts to limit the flow of patient-identifiable health information overseas. A bill recently introduced in Congress by Sen Hillary Rodham Clinton (D, NY) and Rep Edward J. Markey (D, Mass) would require patients to consent to having their information sent abroad.
- Look to the ACR for continued clinical and advocacy leadership. Consult the ACR Teleradiology Resources (White Paper Technical Standards) and Digital Image Data Management for further guidance. All are available at www.acr.org.
