In an exclusive podcast interview, Michelle Dougherty, director of practice leadership for the American Health Information Management Association, tells Modern Healthcare reporter Joseph Conn about the legal issues being raised by the use of electronic health records and other healthcare IT innovations.
Read the accompanying Special Report, Making IT legal-size, which appeared in the May 19, 2008 issue of Modern Healthcare.
[00:00:01.23] Womans Voice: Welcome to this edition of Special Report Extra, brought to you by Modern Healthcare, and powered by Martopia. With each edition of Special Report Extra, listeners hear directly from key healthcare executives involved in the major events shaping the industry.
[00:00:28.18] Joseph Conn: This is Joseph Conn, Im a reporter with Modern Healthcare magazine, and today well be speaking with Michelle Dougherty, director in practice leadership at the American Health Information Management Association. The topic today is going to be the legal e-health record. We wrote an article about this topic in the May 26 issue of Modern Healthcare magazine. Michelle, lets just talk briefly about the work that youve been doing with HL7 and specifically on something called the HL7 EHR-S Records Management and Evidentiary Support Functional Profile. Youve been working on this with HL7. Give us a brief history and an assessment of what that is and what work still needs to be done.
[00:01:20.12] Michelle Dougherty: Thanks, Joe. The HL7 is a standards organization for health information technology, and they have an EHR technical committee, and under that technical committee, they have created standards for functionality, for EHR systems.
One of the processes or protocols that the EHR technical committee had established is to develop profiles, or subsets of functions or requirements for EHR systems that meet a specific purpose.
A number of years ago, there was a group within the EHR technical committee that had started to [unclear] to bring up the issues of how might an EHR system record that is created be used for legal proceedings, how do we manage these records as legal documents that have some credibility and validity, so, as a result, a, what we call a profile, or a subset of functions, was identified by a special work group and we evaluated, you know, what was currently in place for EHR systems that supported a legally sound health record, and then, where were there gaps in functionalities and requirements for EHR systems that needed to be in place in order to make sure that these EHR systems created, you know, valid business records.
[00:02:42.07] Joseph Conn: My understanding, now that you have a work product thats at least in the semi-complete stage and that that has been submitted to balloting by HL7, a process that all standards development organizations use. Explain that a little bit, please.
[00:02:59.24] Michelle Dougherty: Sure, thats correct. You know, with any standard you want to have a vetting process in which various stakeholders have an opportunity to review it, provide comments, basically tweak and massage it. So, it reflects the input from a broader group, and thats what makes a standard good. And thats the process weve been going through with this record-management and evidentiary-support functional profile.
So last summer, in July, we went through a public comment period in which we gathered some very initial input from various reviewers on the profile and from that made some tweaks or massages and it went out for its first ballot in December and January. It was a 30-day ballot cycle.
What were doing right now is reconciling the comments, or finishing up the reconciliation process, where we look at all the comments that came in from the people who submitted votes, and were basically tweaking and making edits to the record-management profile, so that the final form would be a pass ballot, you know, the profile would have passed the ballot process, and we would have received input and validation from the balloters.
So, the final phase that were in now will complete the edits to this profile and actually re-ballot just a couple of items that we made substantial changes to in the upcoming ballot cycle in August, through HL7. So, by the fall, we should have a well-vetted record-management and evidentiary-support standard.
[00:04:31.12] Joseph Conn: Just to be clear, the initial balloting in December, that 30-day period, it did not pass in the sense that you would pass a regular test or something like that, or get voted into office. But then thats not an abnormality for, I understand, for standards, to not pass on the first balloting. In fact, thats fairly normal that that does occur. And so what were going after this next time in August is a second balloting; is that correct?
[00:04:59.27] Michelle Dougherty: Thats correct; and so, youre correct that it did not pass or meet a very high threshold for approval by the balloters, so theres almost an 80% approval rating by those who submitted ballots, and basically, any voter who has even one concern, and this is a fairly lengthy ballot, would have to vote negative, and thats the process that voters use in order to have their concerns addressed. And once you address those concerns, our hope, then, is that voters convert their negative vote to a positive vote. And thats the process were going through, is converting and addressing the issues and moving those votes from negative to positive.
But there were a couple of areas where we made some major changes that need to be visited. Two areas in particular with extraordinary access, like break-the-glass functionality for security, as well as meta data, which is a new, emerging area and what this ballot cycle has done is given us the ability to put out some new concepts, get that feedback, and then get it right through the balloting process before it becomes an official standard.
[00:06:04.02] Joseph Conn: Lets explain what exactly this profile will do and who will be the end users?
[00:06:10.17] Michelle Dougherty: Theres a number of end users for this. I want to backtrack one second, though, and say what will this do, and primarily, for the first time, its identified EHR IT standards that relate to what we call record management, evidentiary support, but kind of overarching the type of functionality that needs to be in place to maintain a legally sound business record. And health records and medical records are used for business records purposes as well, so that angle or perspective really hasnt been in place within HL7 standards, bits and pieces of this topic have been addressed in other standards organizations, this is the first time where we comprehensively have pulled together specific functions and tried to comprehensively address what needs to be in place to support a legally sound record within an EHR system.
[00:07:08.26] Joseph Conn: And who do you suppose will be using this?
[00:07:12.13] Michelle Dougherty: Well, theres a handful of primary users of it; CCHIT, the Certification Commission for Health Information Technology, should be one of the users. They incorporate standards into their certification criteria for testing EHR vendor products. So they would be one potential user for this as it goes through the balloting cycle.
And, in fact, some of their work groups have already started to use the materials that have been created through this, and other aspects of this profile have been, already are incorporated in CCHIT criteria. So, there already are users of it. EHR vendors could directly use this profile and evaluate their system functionality. Is it meeting the legal requirements? What might they put on their road map for development? They could do that independent of CCHIT. And healthcare provider organizations that maintain medical records, would be using EHR systems, would be another user of this profile. And thats been a group that has been interested in it, so as theyre evaluating new systems that they would like to purchase, or evaluating existing systems for dialogue with their vendor, they can use this standard, this profile, to assess whether there is adequate functionality for the EHR system to maintain a legal record.
[00:08:35.20] Joseph Conn: Lets explain now why this has come up, and why do we need to address this issue at this time, and include in that, if you might, something that occurred at the federal level with the trial rules back in December of 2000.
[00:08:51.01] Michelle Dougherty: Well, there are a number of drivers, and not just one, although electronic discovery, electronically stored information within the court system, I think has been a significant driver of this. So, backtracking even further back, as we shift from paper records to electronic records, the uses for that information havent necessarily changed, and so individuals who are records managers within healthcare organizations have had to try to readjust their processes and still meet their different requirements for disclosure of information, so patients will still request their records, so now we have to figure out how to get them out of EHR systems and in a format thats usable and readable for patients. So there is this underlying use of records after the care delivery process has created them. And that could be payment, quality for the patient or consumer themselves. But, what I think that is something thats really risen this topic to the forefront today, is e-discovery, as I mentioned. Back in 2006, the Supreme Court approved an amendment to the federal rules of civil procedure, which changed the discovery processes and protocols used by the courts, and allowed for the incorporation of electronically stored information, or electronic records, and basically created new processes to handle these types of electronic information.
In healthcare, you know, there is litigation that affects healthcare. Sometimes its malpractice, other times its employment. I mean, the variety of reasons and uses for records in litigation, which has caused healthcare organizations to have to start to evaluate their processes, typically, medical records, well, they get used for a variety of things, but if we talked about malpractice, were starting to see this e-discovery rule start to filter into state courts, where malpractice cases typically are tried, and savvy plaintiff attorneys who represent clients in this case are starting to look at electronic records and the possible sources of information that will help their clients, and theyve become savvy on the use of electronic records within healthcare organizations and how they may help their case.
[00:11:06.20] Joseph Conn: Thank you, Michelle. This is Joseph Conn, a reporter for Modern Healthcare magazine visiting with Michelle Dougherty, director of practice leadership with the American Health Information Management Association. Shes been our expert on the topic of legal e-health records. It was a subject of an article that appeared in the May 26 issue of Modern Healthcare magazine.
[00:04:07.26] Womans Voice: Thank you for listening to this edition of Special Report Extra, brought to you by Modern Healthcare and powered by Martopia. Listen to other editions of Special Report Extra by visiting the Multimedia section of Modern Healthcare Online at ModernHealthcare.com