Legal Issues in Health Care

Legal Issues in Health Care

Several laws are existent in the USA given the need to have an effective health care system tailored to meet the needs of the consumer (patients and clients). Laws are essential as they give the health care providers a direction of what they must do. Failure to comply with the same is intolerable given the harsh legal consequences that come with it. A befitting example of legislation that pushes for quality within the USA health care system is the one that relates to the critical incidents reporting of medical errors. In essence, this discussion targets to analyze the existent federal and state laws that tackle this matter. Other key highlights of this analysis include identification of particular health care organization legal obligations on this issue, consequences of non-compliance and management actions to meet the stated requirements. In light of such information, it is beyond doubt that one will be able to appreciate the importance of legislation in health care systems.

Official Title of the Laws

Worth noting are the federal and state laws that look into the issue of medical errors. An existing state law that prescribes the carrying out of the critical incident medical error reporting is that of Maryland. The official title of the legislation is Title 19 (Healthcare facilities) while the section number is 304. The statute is known as ‘reporting unexpected occurrences or incidents; analysis.’ Its designation as a Maryland law is thus MD Hlth-Gen’l Code §19-304 (, 2017).

On the contrary, a federal law that exemplifies the need for medical error reporting in the USA is the Patient Safety and Quality Improvement Act of 2005 section 922 that delineates the privileges and confidentiality protection for patient safety information. The statute prescribes a voluntary reporting system that will enhance the availability of data for assessing and resolving patient safety and health care quality issues (Health Information Privacy, 2017).

Health Care Organization Obligations

Following the stated statutes of Maryland, hospitals of this state have two specific obligations to the patients that are worthy noting. First and most importantly, the healthcare facilities have the legal responsibility of reporting an unexpected event that relates to person’s medical treatment that contributes to demise or disability, and that is not expected in a natural course of the illness. Further still, one should submit the report within 5 days to the Department after the hospital’s notification of the event (, 2017).

Additionally, the other legal obligation that they owe to the patients is to carry out a root cause analysis. The indication for the root cause analysis is the existence of an unexpected event that relates to the individual’s treatment, which results in demise or disability. Furthermore, the hospital must submit the findings of the analysis after 60days of the occurrence notification unless the Department’s approval for an extension (, 2017).

Consequences of Non-compliance

Serious consequences are inevitable for failure to comply with the identified legal obligations. As such, hospitals in the state of Maryland need to adhere to the same if they are to escape such eventualities. For example, the consequence of failure to comply with the legal responsibility for reporting an unexpected event that relates to the medical therapy offered to a patient that result to complication such as disability or even death is lawsuits against the hospital by the affected patients. A case in point of this consequence in real life is evident in a report by the Baltimore Sun newspaper in 2014 that captures the story of NadegeNeim that won a lawsuit against Ellicott City obstetrician, working at Saint Agnes Hospital in the state of Maryland. She secured a $680,000 from the hospital for the damages incurred during her surgical operation. She was a candidate for an operation to excise an ovarian cyst on the left side but instead the obstetrician removed a healthy ovary and fallopian tube from her right side (Cohn, 2014).

That notwithstanding, financial penalties for failure to comply with the obligation of conducting a root cause analysis and submitting its findings within 60 days are inevitable. For instance, according to the Maryland’s directive, the Secretary should impose a fine of $500 per day for every day the violation continues. The imposition of the fine is subject to the Secretary’s discretion (, 2017). In real world example, the Maryland hospital failed to conduct a root cause analysis back in 2001 for a man that lost his legs due to complications after admission because of pneumonia. The consequence of such a failure was the incurring of financial penalty to compensate NadegeNeim following a similar atrocity (Cohn, 2014).

Health Service Organization Management Actions

As a health care manager, one needs to have measures in place that will ensure that the hospital is complying with the stated obligations and thereby escape the harsh effects of non-compliance. An example of a management strategy that can serve this purpose well is the education of hospital staffs on the need to take part in the reporting of medical errors. The training will help demystify that taking part in reporting errors might come to haunt an individual in future in a legal proceeding against them. An action of this kind is thus beneficial since it will foster confidence among the nurses and other health care professionals and increase their participation to the voluntary reporting of medical errors (Cohn, 2014). With such a measure in place, it is undeniable that reporting of the medical errors and other serious reportable events would not be an issue in this medical facility.

Also, the introduction of an online medical incident-reporting system is an important addition that a manager may consider as he/she seeks to address this issue. According to Cohn, (2014) its essence stems out from the fact that it has proven to increase the number of medical error cases reported. That is the case given that it eases the reporting of concerns. Consequently, with such information, trends identification is possible, and improvement of hospital standards is inevitable.

Besides, a manager should also consider voluntarily disclosing information on medical mistakes on the hospital website on a monthly basis. The voluntary disclosure will sensitize the hospital staff on the need to improve the situation and consequently inspire a behavior change. Such an action has proven to be effective in other places since it has resulted in improved care that has subsequently reduced the risks of lawsuits (Smith, et. al., 2014). As such utilizing the voluntary disclosure is also of the essence for managers seeking to improve medical error reporting.


In closure, indeed the issue of critical incident reporting of medical error is a diverse area with many legal specifications whose compliance to the letter is not an option if a hospital wishes to escape legal actions. Such is the case in Maryland State where hospitals owe patients the legal responsibility of reporting medical errors committed. Failure to do so can only result in lawsuits like the one filed by NadegeNeim for an unexpected event she suffered. Therefore, managers have responsibilities of devising measures that will help the hospitals from suffering this fate. A case in point of a measure that they can devise to enhance compliance to legal obligation is educating the hospital staff on the need for reporting the error. With such an intervention, there is no doubt that all hospitals will have an effective reporting system that will facilitate elimination of the harsh effects of underreporting medical errors. As such, it is high time measures like this one are put in place to enhance patient safety.




Cohn, M. (2014). Maryland hospitals aren’t reporting all errors and complications, experts say. The Baltimore Sun. Retrieved from

Health Information Privacy,. (2017). Patient Safety and Quality Improvement Act of 2005 Statute & Retrieved 16 January 2017, from,.(2017). – Medical Errors and Patient Safety – Maryland – Statutes/Rules – Retrieved 16 January 2017, from

Smith, K. S., Harris, K. M., Potters, L., Sharma, R., Mutic, S., Gay, H. A., &Terezakis, S. (2014). Physician attitudes and practices related to voluntary error and near-miss reporting. Journal of Oncology Practice10(5), e350-e357.