Electronic Health Records and Clinical Negligence claims
The NHS began to transfer from locally-held paper-based patient records to electronic health records (EHRs) in the mid-2000s with the plan being to ensure that patients across the UK had centrally-accessible digitally-generated electronic patient records (EPR).
EHRs are widely viewed as a means by which modern day healthcare can be provided in a more efficient and information-sharing way, which in theory will improve patient care. The idea was that there would be a lifelong digital EHR for a patient from cradle to grave, round-the-clock access to a patient’s records containing all necessary information needed to treat the patient, and seamless care through the patient’s healthcare pathway, whether GP, community hospital or secondary care hospital. The potential advantages of EHRs are relatively self-evident: they may improve care and are more efficient, convenient, space-saving and accessible.
Good Practice Guidelines for GP Electronic Patient Records
Unfortunately, the initial plan to deliver EHRs across the UK, known as the National Programme for Information Technology (NPfIT), was an expensive disaster (costing nearly £13 billion of taxpayers’ funds): it was launched in 2002 by the UK government and disbanded in 2011. Since the NPfIT’s resounding failure, the update of EHR systems in the UK has been slow and different hospitals and different Trusts now have different systems provided locally by different IT providers, which adds to difficulties with the roll-out of such a scheme. Additional concerns about EHRs generally include security (phishing, malware, cloud threats, encryption issues, insider threats, data breaches, etc.); reduction in time spent by healthcare practitioners with patients because of the need to learn about and then use the IT (and its associated gremlins); and disagreements as to the extent of access to digital records by patients.
In 2011, the Department of Health, British Medical Association and Royal College of General Practitioners produced a detailed document setting out Good Practice Guidelines for GP Electronic Patient Records , and it must be said that GP records are far easier to navigate and interpret than hospital records. I note in passing in that document that one of the non-clinical purposes of the records is described as: “Providing medico-legal evidence (e.g. to defend against claims of negligence)”; rather interestingly, the example is to defend claims, not simply to provide evidence so that the Court can find the truth of the matter!
Problems For Clinical Negligence Claims
The advent of EHRs has caused problems for clinical negligence claims, too, for a variety of reasons. I have previously written about missing records and the difficulties this can cause in a legal case, let alone with respect to healthcare. In many respects, in my experience, EHRs have made the matter worse rather than better.
With EHRs, some Trusts have scanned in prior written paper records into the EHR but have then destroyed the original source documents. This raises significant problems because at times the scanning is of poor quality, parts of pages are missing, black and white scanning results in the loss of metadata and there has been a resulting loss of source data in the scanning process. If the original source record has been destroyed, this will mean that some data will have been permanently destroyed. Further, the organisation of the EHR is often very difficult to navigate. This is in particular when part of it has been scanned in as a ‘batch’ of records with those scanned records not individually indexed within that batch and not in a chronological order. It may be necessary to open each page of such a scanned record individually to identify its content, which is a time-consuming exercise. There is also often no audit trail with respect to the source data scanned into the EHR, so it cannot be known whether a record had been amended or altered so the integrity of the data cannot necessarily be verified.
Irrespective of the problem with the scanning in of archived medical entries, the EHRs that are generated digitally are also problematic for numerous reasons.
The mere fact that different hospitals and Trusts have different EHR systems provided by different companies causes problems, as different electronic patient records (EPRs) are organised differently and there is a fundamental lack of uniformity across the NHS. With paper-records, there was generally a broad uniformity across hospitals of the lay out and organisation of medical records and one set of records in one hospital would be very similar to another hospital in a different part of the country. This is no longer the case and digital records can vary very significantly.
Further, sometimes the time and date of an entry into an EHR is the time and date the creator enters the data rather than the system-assigned creation date or the date of the event, such as a ward round. This naturally can be problematic when seeking to piece together the chronology of events later on for a legal case. It is also not always clear who the creator of the entry was and sometimes non-medically or non-clinically trained staff will make entries into the EHR on behalf of a health professional. It has often been difficult even with paper records to ascertain who wrote a medical entry but the EHR has not improved the identification of individuals and it can still sometimes take considerable time-consuming investigation to ascertain each individual.
Different departments in hospitals may use different systems, e.g. the Emergency Department (ED) may have a separate system to the rest of the hospital, and such systems do not always necessarily “talk” to each other coherently. This can mean that a particular department will not have access to the patient’s main EHR at a given time, such as when the patient attends outpatients or ED, which defeats one of the main purposes of the EHR.
Pathology results are not always dated and timed with the date and time the sample was taken, which is often the critically important information in a legal case, but rather the date and time the results were obtained from the laboratory or even the date and time the health professional subsequently reviewed the results on the computer system. This is naturally confusing. It is not always easy or even possible to verify precisely when the sample was actually taken, which can ultimately be hugely problematic.
Reproduction To PDF Format
The subsequent reproduction of the EHR into a digital record (usually in the form of a pdf) is almost always problematic. It is much harder to ‘sort’ EHRs than paper records in a standardised way, such as into clinical records, pathology results, operation notes, correspondence, etc., because of the way that the EPR is often reproduced as a continuous ‘stream’ or ‘run’ of data running over hundreds, if not thousands, of pages with different types of data, e.g. the above-mentioned clinical notes, pathology results, operation notes and correspondence, from different dates featuring on one page rather than each being on a separate page of A4, as used to be the case. Before the rise in EHRs, I used a standardised system for sorting and organising all medical records, which aimed to mirror as accurately as possible the layout of the paper-based medical records in hospital, in the order that they would be found in the paper notes. This was possible even when the records were provided in a complete mess, which was a frequent occurrence. However, such sorting is now rarely possible given the problems noted with the way EHRs are reproduced and we tend to end up having to have a ‘core bundle’ of key records which is easier to understand and manage. This is not a problem in and of itself, and I am rather a fan of core bundles even with paper-based records, but there is no doubt in my experience that it takes longer and it is a more time-consuming process to sort, paginate, index and consider EHRs than it was with paper records, resulting in a less user-friendly final set necessitating a core bundle earlier on, all of which is overall a more costly exercise.
With pre-EHR notes, it was relatively easy just using the clinical notes to follow a patient’s health career without the need to prepare a separate detailed chronology, but with EHRs I now almost always prepare a detailed chronology in complex cases (which often then accompanies the Letter of Claim) to set out clearly the sequence of health events because the EHR is almost never in chronological order and, even with sorting, it is just not possible to organise the EHR chronologically and in a way that is easy to follow. Again, I was a fan of chronologies even with paper records, but it is nevertheless time-consuming and, ultimately, more costly to need one in almost every complex case.
Amendments to Records
It was also possible often (although not always) with paper records to see whether a record had been amended, added to or altered in some way, often by the handwriting, the colour of the ink used, the way the note had been written in the margin, etc. This is not so easy with EHRs and, whilst there will be an audit trail on the computer system, accessing that to ascertain when information may have been manipulated or amended would be necessary and is a much more protracted exercise than seeing an amendment on the record face; it is also reliant on compliance from the Hospital/Trust.
The above are just some of the problems now that may be encountered with EHRs in clinical negligence claims. To make matters worse, with the relatively recent change in the law with respect to data protection such that Trusts cannot charge for the provision of medical records when a subject access request is made (the charge used to be £50), Trust medical record departments have been increasingly reluctant to spend time providing missing records or replacing poor quality records (and there are almost always relevant missing records). In fact, generally I now find that if I request missing records, all the Trust does is send another full set of the EHRs (presumably because it is easier just to send the whole digital record to print to pdf than actually search for the missing record). This is a ridiculous waste of our time and likely also reflects how difficult it is to search EHRs for specific missing records/entries.
Having said the above, because the records are now typed, it is definitely easier to read what is written, whereas previously the interpretation of handwriting was a major problem with paper records (noting the joke about how poor doctors’ handwriting is), although sometimes it is still difficult to understand or interpret what was actually meant by what was written even when typed.
Medical records are an absolutely fundamental part of just about every clinical negligence claim, certainly the complex claims. The creation and reproduction of the medical record has always been a vexed issue – both medically and legally, and even before EHRs – but in my view EHRs have not improved the situation. In fact, in my experience, medical records now are generally harder to sort into a coherent chronological bundle and it takes longer and is more costly, usually requiring the extra steps of a core bundle and a separate chronology in the complex cases; it is also often no easier to ascertain who wrote a record and when or, on a record’s face, to see if it has been amended or altered and, if so, when and by whom.
Accordingly, the early steps in the investigation of a clinical negligence claim are now frequently more time-consuming and costly than they were prior to the advent of EHRs; for all their potential healthcare-related benefits, EHRs are as legally problematic as their paper predecessors, if indeed not more so.* Disclaimer: The information on the Anthony Gold website is for general information only and reflects the position at the date of publication. It does not constitute legal advice and should not be treated as such. It is provided without any representations or warranties, express or implied.*