Wednesday, February 6, 2013

Electronic Records Management Compliance

Image Credit: Vivid Learning Systems
While functionality and ease-of-use are extremely important when it comes to the software choice for an office, accountability, security, privacy protection, and legality sometimes take a back seat to sleek features and glossy graphics.

As our world becomes increasingly digital we can expect that more legislation will be put into place.  We can also expect that patients to be more educated about their patient files and security than ever.  Exposure to news stories illuminating consumer privacy issues has rightfully made the general public wary of what’s happening with their information.  When we find ourselves unfortunate enough to require a visit to a hospital, we are aware that a lot of our information is being kept electronically, and we demand the utmost in security, firewalls, accountability – why should the information at dental providers be any different?  It is just as sensitive as hospital records.

Enter guidelines – established and published for the safety of both the patient, and the provider.

RCDSO Guidelines for Electronic Records Management

The Royal College of Dental Surgeons of Ontario (RCDSO) has put together a really good guide which outlines what you should be looking for in your dental software, no matter how much or how little information you plan to retain electronically.  We think it is well worth a look and have included it in this article for your information.

One of the items listed in these guidelines is a Health Canada requirement for a Class II medical device which requires ISO Certification. Currently, of all the practice management systems available in Canada, only two actually meet this requirement.  ClearDent is one of them.

Any patient management software with capabilities beyond basic data visualization, acquisition, transfer and storage is considered a class II medical device, which requires a valid ISO 13485:2003 quality system certification, as well as a valid license for sale, importation and distribution in Canada. This includes any patient management software involved in data manipulation, data analysis, data editing, image generation, determination of measurements, graphing, flagging of results, identifying a region of interest or performing calculations.
(Source: RCDSO_Guidelines_Electronic_Records_Management.pdf retrieved on January 31 from

Another outlines the importance of ensuring that information sent via email is kept private.  There is only one practice management system available in Canada that now includes standardized encryption availability on all documents and emails being sent from the system.  We’ve got it in version 8.4 or higher.


The use of e-mail in our society is commonplace. It is a convenient, inexpensive and quick means of communication. However, as a general rule, e-mail is not a secure means of communication, and may be vulnerable to interception and hacking by unauthorized third parties.

Accordingly, dentists should avoid using e-mail to communicate the personal health information of patients, unless they are employing a secure e-mail service with strong encryption.
(Source: RCDSO_Guidelines_Electronic_Records_Management.pdf retrieved on January 31 from

Additionally, the guidelines stress the importance of a complete audit trail. Complete means that it is tracking what every user logged into the system is doing and must record any changes made to a patient file.  ClearDent has been doing that for years.

At minimum, an audit trail must contain the following information:
A) the unique identity of the accessing user;
B) the role the user is exercising;
C) the practice location and specific computer identification of the accessing user;
D) the identity of the patient;
E) the activities performed by the accessing user;
F) an accurate date and time stamp.
(Source: RCDSO_Guidelines_Electronic_Records_Management.pdf retrieved on January 31 from
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