Several posts on this blog have been devoted to tort reform. More than any other subject, this topic generates more heat than light. Indeed, I describe these debates and comments on this blog and elsewhere as duels, not discussions. Many folks on various sides of this issue earnestly believe that they have the better argument. Other viewpoints are not purely held and are clearly contaminated by self-interest. I have written repeatedly that I believe that the current system is unfair and does not serve the public well. The public understands the issues and the controversies. In general, I don’t think most Americans believe that we have too few lawyers or lawsuits in this country.
It is astonishing that people can defend a medical liability system that:
- Misses the vast majority of patients injured by medical negligence
- Ensnares many more innocent physicians than negligent ones.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Shouldn’t these two inarguable facts be sufficient to demand at least an examination of the current system? If a diagnostic test only detected a medical condition in 5 percent of cases, and caused harm in a sizable percentage of healthy individuals, would we defend it, or try to improve it?
When new medical development occurs, it has legal ramifications for physicians, patients and the plaintiff’s bar. Physicians are held to a certain standard of care — as we should be — which is evolving. It can be murky to determine when a new standard becomes established in a dynamic situation, but this is a critical legal issue. For example, a new treatment may be introduced, and even approved by the Food and Drug Administration (FDA), against a specific disease. Does FDA approval signify a new medical standard? Is common usage alone, without FDA approval, define the standard of care? How many physicians need to be prescribing amedicine for the treatment to be considered standard? 10 percent? 20 percent? Could a physician successfully argue that lack of FDA approval of a treatment indicates it should not be regarded as the standard of care? If a conservative practitioner like me delays prescribing new medicines until there is a longer track record safety and efficacy, could I be charged with deviating from the community standard? I recall my reluctance to prescribe a new irritable bowel syndrome medicine years ago because I didn’t feel there was sufficient clinical experience for this new drug that was treating a benign, albeit troubling, disease. Sometime afterwards, the drug was pulled from the market after some patients died. I suggest that prescribing new treatments or diagnostic tests too soon might constitute a deviation from a judicious standard of medical care.
As Whistleblower readers know, our office instituted electronic medical records (EMR) this past September. It has been a spirited contest of man vs machine, but I think that we will ultimately prevail. The battle has been more prolonged than we anticipated. We knew there would be many challenges. We didn’t expect, however, that there would be so many unforeseen obstacles, which continue to try to derail us. When your smiling EMR vendor shows up in your office and shows you an awesome demo, think WWRD, or what would Reagan do. “Trust, but verify.”
EMR has been advocated as an advance that will diminish physicians’ legal vulnerability by providing much better documentation and communication with colleagues. While this may be true, the nascent technology has created gaps and fissures that are portals for lawsuits to sail through. The New England Journal of Medicine has published a review highlighting the medical malpractice risks of EMR in its November 18th issue. I have disseminated this article to my partners and staff and strongly urge readers to do the same. Here are some of the essay’s highlights, including some of my own observations.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
- EMR usage and reliance upon various clinical support capabilities that advise on clinical decision making and practice guidelines may change the existing standard of care. In other words, failure to rely upon these increasingly available clinical support resources could be considered to be a deviation.
- EMR use may become the standard of care itself, making those who cling to paper charts legally vulnerable.
- Physicians are especially vulnerable during the transition phase from paper to EMR when they are caught between the two systems. Our practice has experienced numerous snags and setbacks during this time period. I have had to repeatedly return to EMR notes to correct errors that were inadvertently or mysteriously inserted. Some are easy to identify, such as when a hysterectomy is listed on a male patient’s past medical history. Other goofs may be much tougher to spot in the lengthy and formulaic computer notes. When several individuals are responsible for entering data in a patient’s record, errors are invited.
- Does the EMR software permit the physician to document his treatment plan, explaining his thinking and judgment involved in the medical recommendations? Or, is the “plan” limited to a list of diagnoses? The latter might not provide much assistance to your defense counsel if you have to rely upon these thin record years after the visit.
- Does your practice have a plan in place when the inevitable computer crash occurs?
- How has your practice documented that all medical information in the paper record has been transferred to the EMR record?
- The cut-and-paste technique that many physicians use in EMR risks omitting important new medical information and perpetuating inaccuracies.
- Computer technology now gives access to various patient data bases at the time of the visit. Are physicians obligated to search through area hospitals’ and other organizations’ patient data bases to review all records contained there? Many patients have years of lab and imaging study results in various locales that we now have access to. The legal ramifications of this are obvious.
Of course, EMR will also protect us if we use the system well and are meticulous about our usage. If we document phone calls that direct patients to the emergency room or to a specialist, then this can stifle a lawsuit. Similarly, the EMR record can document that patients were notified of test results and were given instructions on when to follow up with us. But, I fear that, at least in the short term, the legal risks for us exceed legal protections. We need to be vigilant, not only to protect our patients’ health, but also to protect ourselves.
Alas, EMR will not be the Era of Medical Liability Reform.
