In healthcare, every step counts, and keeping track of those steps is even more vital. That’s where the audit trail in healthcare comes in — it's a tool that helps patients and doctors, especially when things go medically wrong. From patient records to staff actions, an audit trail provides clarity and confidence, both for medical and data privacy purposes.
Here, we’ll discuss the basics of an audit trail in healthcare and its relevance in medical lawsuits, whatever side you’re on. This article can be used by lawyers and also serves as an educational piece for their clients.
What is an audit trail in healthcare all about?
Whether as physical documents or soft copies, healthcare records contain important, confidential information about a patient. Mainly, these records show the medical history of a patient and the medical care that they received from a particular institution or professional.
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An audit trail in healthcare is a chronological summary of the specific persons who accessed the record, including the time and date it was accessed. These include the patient themselves, their doctors, or any other hospital staff.
Additionally, an audit trail in healthcare may also show:
- the records of the date and time of each patient’s entry of information
- the type of information that was accessed or modified
- the identity of the person who accessed or modified the information
- the specific changes to the recorded information, and the dates it was changed
- the original healthcare record before it was changed or updated
Because these records form part of the overall information of a patient, they are also protected, or indirectly governed, by data privacy laws. In Canada, these laws are a combination of federal and provincial or territorial laws.
This video shows why access to healthcare records is important:
For more information about the importance of audit trails in healthcare claims, reach out to any of the best medical negligence lawyers in Canada as ranked by Lexpert.
Is it required to have an audit trail in healthcare?
Physicians and hospitals are required by law and rules by regulatory bodies to maintain an audit trail for the records that they’re keeping. Aside from using these audit trails in litigation, physicians and hospitals must be aware of these rules to prevent any penalty for professional misconduct.
Data privacy of healthcare records
The use of audit trails in healthcare is also related to a patient’s right to freedom of information and right to privacy of their medical records. Each province and territory in Canada have their own data privacy laws (BC’s Personal Information Protection Act), or those that are specific for medical health records (Ontario’s Personal Health Information Protection Act).
These laws may also govern:
- what an audit trail should contain
- the persons allowed to access a medical record
- how an audit trail should be handled by a hospital or a medical professional
As a rule, only the patient is allowed to access their medical records, since these are highly confidential information. It means that these should not be accessed easily by any other person. The exception is the patient’s own doctors, e.g. when learning more about the patient’s medical history, they can access the patient's records during their care.
These privacy laws, as related to the requirement on audit trails in healthcare, can be used in a medical malpractice or negligence case. For instance, non-compliance with these data privacy laws may be offered as evidence of negligence on the part of the doctors and the hospital.
Practices among medical professionals
Aside from complying with statutory requirements, audit trails in healthcare may be advised, or even required, by regulators and institutions among the profession.
Primarily, the provincial and territorial Colleges of Physicians and Surgeons require hospitals and doctors to have audit trails of the medical records that they’re handling. This is in addition to other requirements, including ensuring data privacy and confidentiality of patient’s medical information.
Audit trails as required by regulators
One example is the policy on Medical Records Management by the College of Physicians and Surgeons of Ontario (CPSO), in relation to the provincial Medicine Act. It says that every physician, who has custody or control of patients’ electronic records, must:
- maintain an audit trail for all accesses of a patient’s personal health information, even if no changes were made to the health record
- use an electronic system that will record each entry for each separate patient, indicate any changes to it, and preserve its original content
Audit trails as required by other institutions
One of the good practices that the Canadian Medical Protective Association (CMPA) promotes is for physicians to have e-records with an audit trail. This will be a log of the activities in the record that shows important details, such as who accessed the record, their activities, and any alterations.
Whether required by a College or the CMPA, an audit trail must be able to distinguish the original unedited version, versus the changed or updated one. Audit trails must also be read together with other record-keeping requirements imposed on physicians by these institutions.
How do these audit trails work in medical negligence claims?
Medical malpractice lawsuits heavily rely on the information about the patient’s medical history and its use by their doctors. As such, audit trails in healthcare can show contentious information that may not be accessible in any other document.
This is why these audit trails can either make or break a medical negligence case; it can further a patient’s claims against their doctors or set up a defense on the part of the doctors.
While this video talks about audit trails in general, it can still show why audit trails are important for an organization:
You can use our directory of the Lexpert-ranked best medical negligence law firms in Canada to get more help when it comes to audit trails in healthcare.
For defendants: healthcare professionals and institutions
Physicians and hospitals are usually the defendants in medical negligence or malpractice claims, or even in medical data privacy cases. This is why having a good audit trail in healthcare is vital for their defense.
Here are the viewpoints that those in the medical field can consider as their defense when using these audit trails:
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To show compliance: It’s clearly established that having an audit trail is required for physicians. Having a well-maintained and compliant audit trail means that the defendant is a legally complying professional. This can work well on a defendant’s case as they must present an almost clean record of their profession.
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To prove diligence: Proving that the doctor has been diligent in all aspects of the patient’s medical healing is the basic, but most effective defence against a medical malpractice suit. To help in this defence is an audit trail in healthcare; example, if it’s shown in the audit trail that the doctor accessed the patient’s medical records before diagnosing them, then it’s a good indicator of diligence and good faith.
For plaintiffs: patients and their families
On the other hand, plaintiffs in a medical malpractice or negligence case would be those injured or their family members. For them, an audit trail in healthcare can also be used in their favour.
Below are some of the ways that audit trails can be used by plaintiffs in these cases:
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Wrongful alterations: Medical records are only valid as far as they’re unaltered and contain accurate information. However, when it’s wrongfully altered — as shown in the audit trail and most specially after the controversy arose — this can be used against the defendant to show that they’re acting in bad faith. This unlawful alteration would also disprove any defense that the doctors or hospital would be putting forward that might come out of the medical record.
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Records were not accessed: When a medical malpractice or negligence case is based on an erroneous diagnosis or medication malpractice, looking at an audit trail in healthcare is essential. There, the plaintiff can prove that their physician never accessed their records before making a diagnosis, or that they only accessed it at a later time.
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Violation of data privacy protection laws: In relation to when a medical chart is only accessed later (e.g. when a patient has already complained or when a case in court is already filed), a doctor who did so have violated the laws and regulations on the privacy of a patient’s medical records. Aside from the fact that it can be a sign of negligence on the part of the physician, it’s prohibited for physicians to access a patient’s records long after their care and just based at their own whim.
What are the best practices when keeping an audit trail in healthcare?
With all these discussions on the importance of audit trails when it comes to defending doctors or hospitals, we’ll now go through some advice when keeping a medical record or its audit trail. Of course, this is not a substitute for a legal counsel, that's why consulting a medical malpractice lawyer is crucial.
If you’re a physician or a part of a medical institution, the following are just some of the best practices that you can use:
Learn the specifics under the law
One thing that a lawyer can help you with, when working for the defense, is to simplify these complicated data privacy laws, as applied to the healthcare industry. To add on federal laws, there are provincial and territorial laws that may differ from one another. Not to mention that we also have the codes and rules by the Colleges that must be considered.
Know what should be included
At its simplest form, an audit trail must reveal what events occurred, at what time and date, and who caused such an event. In must be arranged in chronological order and must have the specifics as required by law.
Consider the system to be used
While an IT system that has an audit trail feature that would make things easier, you must also be wary of its security. Systems must be set in place to ensure that not everyone has direct access to important data.
Audit trail in healthcare: path to recovery in malpractice cases
An audit trail in healthcare is more than just a legal requirement — it’s a crucial tool for protecting patient privacy and ensuring accountability in medical practice. Whether you’re a healthcare provider striving to meet regulatory standards or a patient seeking justice in a malpractice case, maintaining a well-documented audit trail can be the key to your case. By understanding the role of audit trails, both physicians and patients can ensure that their rights and responsibilities are safeguarded.
Bookmark our page on Lexpert’s Legal FAQs for more articles on medical negligence or malpractice cases, aside from discussions on audit trail in healthcare.