Minimize your liability when sharing patient information electronically.
By Paul Peng, O.D., J.D.
Telemedicine is the delivery of medical care from a remote location. Currently, ocular telemedicine is one of the top five uses of telemedicine in the nation. So what's this trend all about? I'll explain.
Telemedicine in perspective
Telemedicine wouldn't exist if it weren't for ocular digital imaging. The number of eyecare professionals incorporating digital imaging into their practices is growing at an exponential rate. They're using digital imaging for medico-legal documentation, to educate patients, manage chronic conditions such as diabetic retinopathy, communicate professionally and even for remote teleconsultation!
New standards, new worries
With the recent legislative change that mandates Medicare to pay for telemedicine consults, digital transmission of patient information within cyberspace will become a new standard of practice. But as with any new standard of practice, you need to know how to avoid the potential lawsuit pitfalls. Consider the following case.
Caring for Mr. Doe
Dr. Mann practices in a rural region of state X. He recently equipped his office with a digital camera that's linked to the Internet.
Dr. Mann saw Mr. Doe, who had an interesting retinal lesion. Dr. Mann captured an image of this finding and explained it to Mr. Doe. Dr. Mann told him that he planned to send the image to Dr. Brown of State Y to take a look.
Based on Dr. Brown's comments, Dr. Mann referred Mr. Doe to a retinal specialist 100 miles away for a consult. The retinal specialist concluded that the lesion is benign and now Mr. Doe is upset because it was a nuisance for him to drive 100 miles. If Mr. Doe initiates legal action to recover damages for his time and effort, he may challenge Dr. Mann on the factors listed below.
Anyone who intends to send digital information regarding any patient should consider the following points:
- Consent. The law requires the patient to sign a written consent form. For telemedicine purposes, the form must address who you're sending the information to, and for what reason(s). Based on the facts presented, it's clear that there was no true legal consent between Dr. Mann and Mr. Doe.
- Confidentiality. Patient privacy is the most important aspect of telemedicine today. Specific guidelines are set forth in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA established the standards of privacy for individually identifiable health information.
HIPAA defines the rules that give patients greater access to their own medical records and more control over how healthcare professionals use their personal health information. Transmitted information is subject to the rules set forth under
In Mr. Doe's case, unless the channels of communication were secure, the image that Dr. Mann sent as an attachment containing Mr. Doe's vital information may have been intercepted, thus violating his privacy. The sending doctor needs to consider methods or software that allow encryption. An economical way to address this is to simply send patient information in separate messages or with assigned identification numbers for each patient's files.
- Role of the parties. The patient must understand the relationship between the parties involved in assessing his ocular health. Therefore, the sending doctor must convey to the patient that he's sending the information to another professional either as a consultation or a second opinion. This is vital, as different levels of liabilities may attach in the event of a misdiagnosis.
- Consultation. The consulting doctor forms a direct relationship with the patient. All parties must make sure that the patient interprets this new relationship as a consultation and not as the involvement of another practicing eyecare professional. This is important because the word 'consultation' carries different meaning (liability) from the patient's or the court's perspective.
Also, if the consulting doctor is out of state, he must make sure that his actions won't be construed as practicing outside of his licensing limit. If the patient initiates a lawsuit, aside from suing for malpractice, the patient could also accuse the consulting doctor of practicing without a license!
The consultant should bill the patient via the doctor who sent him the information or the doctor who submitted the consultation to minimize liability. This simplifies the relationships, insurance issues and liabilities.
- Second opinion. This relationship exists strictly between the sending and receiving parties. In the event of litigation, the doctor providing the second opinion may mitigate liability by showing that the sending doctor used his own discretion as to whether to rely on the other doctor's second opinion. Avoid problems by not providing the doctor giving the second opinion with certain patient personal data (e.g., name, address, social security number, insurance information). Also, the doctor giving the second opinion should only bill the asking party for his services -- not the patient.
Be mindful of standards
Telemedicine is an emerging field and numerous governmental agencies (including federal statutes such as HIPAA and Medicare) exist solely to regulate this problem. The government is trying to regulate telemedicine and has established such agencies, but many product users aren't aware that such standards exist. So in the event of a legal challenge, the patient can attack the doctor for not obeying the law.
Regulatory standards apply to the actual hardware or commercial packages, the actual digital images and all electronic records. It's important to know about these standards because they could legally interrupt your practice.
The bottom line is this: You can't just go to an electronic store and put a system together. If you do this and something goes wrong, these regulations will come into play against you.
- Hardware/commercial package standards. Confirm that the hardware or commercial package you purchase is 510(k) certified. This term originates from section 510(k) of the Federal Food, Drug and Cosmetic Act. It applies to any newly developed medical device (including digital imagers).
- Digital image standards. The de facto (actual) standard for medical imaging is Digital Imaging and Communications in Medicine (DICOM), which is also the international standard for graphic images from visual field analysis and corneal topography. The American Academy of Ophthalmology has been an active member of the DICOM Committee since 1997.
- Electronic record standards. Health Level Seven (HL7) develops the standard for electronic messaging and medical records. It's one of several ANSI-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. HL7's domain is clinical and administrative data. Any paperless patient record software that's often included in any commercial imaging package system should be HL7 compliant. Without proper standards, different digital and electronic medical records simply can't communicate with each other.
Proceed with caution
As Medicare begins to reimburse digital imaging for
telemedicine, interest will grow both economically and legally. Therefore, all participants must be aware of the potential for danger.
So before you rush into creating or buying an imaging system, remember what we discussed here because something that seems so right and easy could quickly become so wrong and difficult. As illustrated from our example, what seems like a simple situation is actually filled with factors that could lead to potential problems.
DR. PENG IS IN PRIVATE PRACTICE IN CASTRO VALLEY, CALIF. HE'S AN ASSISTANT CLINICAL PROFESSOR AT THE UNIVERSITY OF CALIFORNIA, BERKELEY, SCHOOL OF OPTOMETRY. HE'S ALSO A CONSULTANT IN VARIOUS ASPECTS OF LAW INVOLVING OPTOMETRY.
Optometric Management, Issue: November 2001