Cover Story: Electronic Healthcare Delivery
A Challenge for Legal Counsel
|by Henry C. Fader
Winter 1999, Vol. 62, No. 4
A traffic accident victim is assessed and treated by a paramedic in a rural community with the assistance of a trauma surgeon in Philadelphia utilizing a telemedicine link. A 75-year-old grandmother with diabetes prepares for a telehomecare visit with her visiting nurse who has been assigned to ensure compliance with the physician's disease management directives. A patient in a nursing home receives a consultation from her neuropthamologist through a telemedicine consultation, avoiding the need to be transported by ambulance to his office. These and similar scenarios are occurring daily, made possible by new medical technologies.
While all of us marvel at the inroads computers, telecommunications and other electronic technologies have made in our daily lives, they are also revolutionizing the way healthcare is delivered to patients. A number of technology issues are now converging. First, patients are demanding to know more about their treatment and treatment options-a major shift toward self-management of disease and medical issues. Second, technology vendors are developing new products to assist healthcare providers to be more efficient and cost-effective. Third, new technology systems actually permit providers to deliver better and more comprehensive care. And finally, state and federal regulators are establishing new standards for the delivery of healthcare in an electronic format.
Lawyers advising clients in the healthcare industry need to be aware of how the laws that typically applied in a paper-based, face-to-face system will work in an era of digitalized databases and the broadcast of images over long distances. In an era of Internet Web sites, telemedicine and e-mail, what are some of the foremost legal issues that healthcare attorneys need to be aware of to provide guidance to clients, regulators and legislators?
Healthcare Web Sites
A recent survey by the Harris poll revealed that sixty-eight percent of adults using the Internet seek health information. Thousands of Web sites exist today to respond to this huge demand. Many healthcare service providers who are clients are forced by market and competitive pressures to provide Internet Web sites to maintain their "brand name," often without first conducting a thorough analysis of the risks involved. What mechanism is utilized to review posted medical information on a medical Web site? Is it the responsibility of the marketing department or is there a panel of healthcare providers reviewing the material? Even in a passive site, misinformation can still expose a healthcare provider to liability. What about other Web sites that are linked to a client's site? Who reviews those sites for accuracy and potential exposure? If the client has an interactive Web site, and patients or visitors are encouraged to provide personal information or medical records, what responsibility does the provider have to protect the information? At what point is the provider practicing medicine by responding to medical questions that are posed to them via their Web site? Some healthcare sites today are targeted to the needs of children or adolescents, and special rules exist for the protection of information about this vulnerable sector of the Internet's visiting base. Does the client follow these new rules and accepted standards?
The engine that fuels many Web sites today, even in the nonprofit sector, is advertising. How do even informational advertising postings on a client's Internet Web site comply with FDA standards? Are advertisements handled in such a way as to avoid an investigation over referrals to the advertiser? Do they endanger the tax-exempt status of the nonprofit provider? In responding to some of these questions, a careful practitioner will look at the Pennsylvania statutes and regulations. Attorneys will not find much guidance when it comes to advising healthcare clients on medical technology issues, however. On the issue of patient record confidentiality, for example, current rules demonstrate a clear assumption of a face-to-face visit and utilization of a paper-based medical record. There is no determination of when an inquiry over the Internet establishes a physician/patient relationship that would trigger protections under the Pennsylvania Medical Board Regulations.
Telemedicine is one of the most misunderstood terms in healthcare technology today. Sometimes referred to as "telehealth," it offers the possibility of a new way to deliver care to patients, especially those who would normally have difficulty accessing care due to their geography or socioeconomic status. In addition, the potential of telemedicine to reach patients and link them to physicians at any time and place will empower both patients and care givers at a level never previously known. Through the use of computers, telephone lines, satellites and other technologies, physicians will be able to transmit medical images, pictures and videos of patients to other healthcare professionals to assist in treatment.
Presently, the most widely used technology in telemedicine is the "store and forward" approach, which permits images, medical charts and other pertinent patient and referring physician notes to be sent electronically to consulting physicians for review when they have the time or availability. This technique is extremely common today in the field of radiology, allowing radiologists to cover a number of hospitals or clinics from a single site. However, there are at least four areas of legal concern that have developed for healthcare provider clients:
Most states require full and unrestricted licenses for the practice of medicine and other healthcare consultation across state lines. No statute in Pennsylvania currently addresses licensure for telemedicine. Other states have passed special legislation with a limited licensing approach, permitting telemedicine consultation by out-of-state providers.
The economics of telemedicine still requires a payment source. Medicare is now paying for certain telemedicine consultations, due to Congressional pressure from rural states, but the rules are limiting and it is difficult for providers to achieve full compliance. In Pennsylvania, the Medicaid program does not pay for telemedicine consultative visits.
It is not clear how the courts will view liability issues arising from telemedicine visits. Our firm advises clients that informed consent and adequate disclosure as to the experimental nature of the technology should be part of the admission package. Jurisdiction and forum shopping are definitely issues that will arise from litigation. The existence of telemedicine consultations may also establish a new level of community standard.
The protection of patient information is a major issue in the delivery of care through telemedicine. The existence of names, electronic medical records (an essential aspect of a telemedicine consult) and video images of patients in compromising positions and angles will all require the highest standards of protection and security. While arguments are heard regularly that paper records are also susceptible to disclosure, telemedicine is somewhat different because of the vulnerability of the telecommunications system over wide areas and the archiving of patient encounters for future consultation. Emerging case law on e-mail and the Internet will set some of the standards. However, Congress mandated that a federal standard be developed several years ago in the Health Insurance Portability and Accountability Act of 1996. While the deadline for the passage of the actual standards to be followed was August 21, 1999, practitioners in this area expected passage of some type of detailed standard by the end of 1999. Without federal or state legislation protecting the privacy of this information, there are no Pennsylvania statutes that one can look to for comprehensive guidance regarding the confidentiality and security of electronic patient records.
Patient and healthcare providers are becoming more comfortable with the use of e-mail for medical correspondence. While many of the same issues surrounding Internet Web sites and telemedicine apply to e-mail, there are two important legal issues surrounding the use of e-mail that require further discussion.
First, providers who respond to the medical concerns of their existing patients need to carefully document the interaction and encounter. Many defense lawyers and medical malpractice insurance carriers emphasize that the filing of e-mail correspondence should be treated as seriously as written telephone notes and medical notes made in a face-to-face visit. This is especially true in an academic medical center setting where a tremendous volume of patient inquiries is received by the staff.
The second issue that requires careful review is whether the use of e-mail will increase the number of consultative opinions and treatment regimens that the patient will seek independently without disclosing such information to the providers being queried. This could lead to issues over standards of care and which physician was responsible for which treatment regimen. The growth of e-mail usage in the healthcare area should, ultimately, become as commonplace as the telephone.
Healthcare Technology and the Law
Advances in technology applications will require healthcare lawyers to keep abreast of changes to traditional principles and protections. Future healthcare organizations may lose their local provider flavor as technology permits delivery of diagnosis and care, forcing legal counsel to deal with issues such as jurisdiction and newly accepted community standards of care.
With the advent of disease-based management software and the need to become more cost-effective and productive, patients, providers and their attorneys will continue to seek the best ways to protect their respective clients.