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Teleradiology has been the pre-eminent leader in the combined use of electronic and communication technologies in the provision of patient care. Typically defined as the electronic transmission of radiological images from one location to another for interpretation and/or consultation, teleradiology is used to maximize efficiencies, increase productivity and expand coverage options for hospitals and emergency departments, as well as multiple-location outpatient facilities. Some radiologists say that teleradiology also affords them a more amenable lifestyle by allowing them to meet professional obligations without requiring a constant on-site presence. Teleradiology is continuing to evolve as hardware and software product support are becoming more sophisticated. In addition, image transmission has improved as telecommunications companies have made broader bandwidth available. Telemedicine, including teleradiology, is used to supplement health care services in remote areas, especially for medical assistance patients, who might have difficulty driving to specialists. While radiologists are beginning to enjoy the benefits of teleradiology on multiple fronts-professionally, personally and financially-accreditation agencies and government regulators are increasingly scrutinizing the practice to ensure that quality has not suffered. Further, in our litigious society, providers must guard against risks associated with using a new modality of care. As a result, many health systems, malpractice insurers and others responsible in the event of a mishap are focused on liability and exposure issues such as credentialing, licensing, equipment standards, archiving, security and the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and equipment testing. Radiologists (hospital-based or not) and institutions may be held to higher standards, as teleradiology becomes the normal medium for imaging services. In addition, as pressures mount for more cost-effective services, some groups and institutions are reaching out to regional, national and international imaging solutions. Areas of risk In light of these developments, some of the areas of risk that need to be considered include the following: Physician qualifications/credentialing. All radiologists must meet the qualifications established by the American College of Radiology (ACR), the Joint Commission on Accreditation of Healthcare Organizations or other respected accreditation bodies for credentialing of telemedicine/teleradiology providers. The Joint Commission on Accreditation of Healthcare Organizations’ Medical Staff Standards MS.4.120 and MS.4.130 (2004) specifically address the credentialing issues of telemedicine, including teleradiology, and its Leadership Standard LD.3.50 concerns the use of licensed independent practitioners. Due to data storage of images for later interpretation, the radiologist may not be able to simultaneously communicate with the technician on site with the patient. As a result, images may not be precisely like those that could be obtained if the radiologist were on site and could directly oversee the technician’s activities. It is essential that radiologists who will be interpreting images by teleradiology understand the basics of the system being used and be knowledgeable of its limitations. Multiple licenses? Licensing. Licensure by radiologists and other physicians who provide services across state lines continues to be controversial. Most states interpret their licensure statutes to require full and unrestricted licenses for the practice of medicine across state lines. This means (in most states) that radiologists in another jurisdiction who are receiving radiological images for review and interpretation may also need to be licensed in the state from which the images are transmitted. This is especially true if the regulations of the jurisdiction where the transmission originated requires the storage of the interpretative report on its premises. Failure to abide by state licensing laws across state lines could result in civil and criminal penalties as well as disciplinary proceedings. As many radiology groups and hospitals reach out to practitioners in other states and other countries for the interpretation of images, they will be required to address and abide by laws regarding licensing as well as credentialing requirements of their own medical staff. This remains an area of some uncertainty. Equipment standards. The equipment used in teleradiology obviously will depend upon the particular needs of the facility and its community, and should be of the quality and availability that is appropriate to the circumstances. The equipment should comply with the ACR and National Electrical Manufacturers Association’s digital imaging and communication in medicine standards for all new acquisitions, which may be found at http://medical.nema.org. It is essential to use equipment of such type and specification that will prevent loss of clinically significant information in transmission. Adequate error-checking capability is also important. While data compression is certainly useful to increase transmission speed and reduce storage requirements, it must not reduce clinically significant diagnostic image quality. It is the responsibility of the radiologists to ensure that image quality is maintained appropriately. Electronic archives. Many organizations are using electronic archiving as part of their picture-archiving and communications systems. The ability to retain and retrieve images by remote access from prior examinations (especially involving different sites), as part of the electronic medical record, is an essential benefit of teleradiology systems. However, there are many state and federal regulations regarding medical-record retention. The storage facility should, at a minimum, be at the transmitting site as required by that jurisdiction. The stored image should be considered by regulators as an “original” for retention. The question is whether a digitized compressed image meets that test under the law of the particular jurisdiction. For example, if a patient arrives at another provider within a health system for care and the new provider retrieves the image previously stored in a compressed state, if the compressed image is distorted, there may be a concern over the quality of the diagnosis and treatment, resulting in liability exposure. Ensuring privacy Security and HIPAA. HIPAA compliance with respect to patient privacy and security regulations is of utmost importance. Many current imaging systems will require modification to comply, especially with radiologists working from home and in light of the wireless systems that are now available. As the area of access expands to outpatient clinics, emergency departments, physician offices or nursing stations, or even the wider community over the Internet, appropriate procedures to ensure privacy and security, such as encryption, need to be put in place by institutions and radiologists. While there is no private right of action under HIPAA for privacy or security breaches, there could be privacy exposure under state law and enforcement risk from the U.S. Department of Justice’s Office of Civil Rights. Liability and jurisdiction. In the event of a medical misadventure regarding the reading of the teleradiological image or other problem resulting from the teleradiology process, such as the use of dyes and other contrast mediums and implantation of medical devices, litigation may ensue. If the radiologist reviewing the image is in a jurisdiction other than the jurisdiction of the patient, this may allow the plaintiff to venue shop. Since tort laws and caps on noneconomic damages vary from state to state, which jurisdiction should permit the suit and which state law should apply? Should it be the state of the patient’s location, the state of the physician’s location or the state in which the physician is licensed? The impact on radiologists and institutions that decide to cross state lines could result in a higher cost of defending litigation, such as the potential for application of the least favorable law, and/or a suit brought in multiple jurisdictions under different theories of liability. Finally, the standard of care may differ from location to location (for example, city versus rural, the type of institution, etc.). Testing. Testing is important under the ACR’s guidelines for teleradiology that became effective on Jan. 1, 2003. Such guidelines call for quality control, and documented policies and procedures for monitoring and evaluating the management, safety and proper performance of the system. The ACR recommends a testing image such as the Society of Motion Picture and Television Engineers (SMPTE) test pattern to be captured, transmitted, archived, retrieved and displayed at appropriate intervals, at least monthly, to test the overall operation of the system. The SMPTE test ascertains the image quality on a video monitor. Such test patterns may be used to assess the capability of a monitor to display gray-scale images, and help one determine whether the contrast and brightness settings of a monitor are acceptable. Other countries What happens when teleradiology is outsourced offshore? International teleradiology affects medical staff credentialing, business models and language barriers. Data transmissions must adhere to administrative, technical and physical standards of security under HIPAA. Additionally, ongoing training of offshore staff in privacy and security measures is critical, given the high turnover rate of personnel in offshore facilities. Quality and adherence to a high standard of care are essential for the outsourced teleradiology to be accepted as part of a U.S. electronic medical record. “Nighthawk” radiology is the phrase used for night-reading teleradiology services, where radiologists review images transmitted from hospitals and electronically send interpretative reports. It has grown in popularity due, in part, to a shortage of qualified radiologists, an increase in patient volume in hospital emergency departments, an increase in imaging studies ordered by physicians, and the provision of relief from middle-of-the-night “on call” burdens. In 2003, the ACR set up a task force on teleradiology, which finalized its findings in 2005 in a study entitled “Report of the ACR Task Force on International Teleradiology.” See Journal of the American College of Radiology, Vol. 2 No. 2, February 2005, at 121 et seq; report updated May 2006. There are several ways that the ACR found to structure international teleradiology arrangements: One is through rotation, whereby the employee rotates to a group-owned facility out of the country, allowing the group to continue to provide fully licensed group radiologists who are U.S.-based. Another involves U.S. physicians providing imaging and interpretative services from abroad to other groups and facilities in the United States. There could also be contractual arrangements with foreign imaging groups whereby the physicians are licensed and credentialed in the states and facilities where they are providing imaging services. The ACR did not approve of the use of physicians located in a foreign jurisdiction and institution if the physicians were not licensed or credentialed in the jurisdiction where the patient imaging took place. A controversial practice called “ghost readers” has emerged, which the ACR task force refused to approve. In fact, the ACR task force issued the following statement: “It is unethical and likely fraudulent for a physician who has not personally interpreted images obtained in a radiologic examination to sign a report or take attribution of an interpretation of that examination rendered by another physician in a manner that causes the reader of a report to believe that the signing radiologist was the interpreter.” In fact, Medicare will not pay for any radiologic interpretations made outside the United States, 42 U.S.C. 1395y(a)(4). Typically, foreign readers perform “preliminary” reports, then send them to domestic physicians, who in turn provide the “final” reports. This approach provides a quality verification to the interpretation. Some of the ACR task force report recommendations for foreign radiology services include the following: Foreign imagers should obtain malpractice insurance. Foreign imagers should be contractually bound to participate in the defense of a malpractice case. Foreign physicians should participate in quality-assurance exercises on-site at the facility. Physicians reading emergency cases should be available for consultation. Managing risk In general, teleradiology should benefit patient care as well as assist in providing cost-effective, productive services by radiologists. Participants should consider the following risk-management tips: An institution should be certain that all its radiologists are properly licensed, carry malpractice insurance and are appropriately credentialed at the same level as the medical staff of the hospital wherever services are provided. If the institution decides that credentialing can be met through meeting the standards of another jurisdiction, this decision should be properly documented. Facilities should also have a quality-improvement committee, composed of qualified experts, review the operations of the teleradiological equipment and procedures. Furthermore, they should ensure that HIPAA and all current privacy and security standards are being met. Radiology groups that contract with hospitals and provide teleradiological image-interpretation services should maintain quality control, through continual evaluation and testing, to their equipment, wherever located. Organizations should check with their insurer to make certain that whatever relationships they develop for teleradiology with other physicians are covered by the institution’s or practice’s liability insurance. They should also be sure that any contracts entered into with radiologists in foreign jurisdictions contain enforceable indemnification provisions. Finally, images should be archived domestically in the institution where the images are transmitted and remain under the control of that local entity. While guidelines, accreditation standards and legal standards are still developing for teleradiology, great opportunities exist for those individuals and institutions that desire to develop an expertise in a delivery system that is efficient, productive and may greatly enhance the care delivery process for patients. Balancing the risks and rewards is what most U.S.-based health systems are doing. While understanding the risks to the delivery of patient care, they must find ways to keep up with the high volumes of imaging studies in both emergency and routine care. Henry C. Fader is a corporate and health care partner at Philadelphia-based Pepper Hamilton and leads the firm’s health care practice group. He may be reached at [email protected]. Sharon R. Klein is the partner in charge of the firm’s Irvine, Calif., office. She handles a variety of corporate and intellectual property matters, in particular those related to technology and outsourcing. She may be reached at [email protected].

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