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Meaningful Consent

Informed ConsentWhen it comes to electronic personal health information (ePHI), there is no lack of guidance for healthcare professionals on how it should be handled to remain HIPAA compliant. However, the way in which ePHI is exchanged is rapidly changing and a patient must consent to an electronic health information exchange (eHIE). Some providers have a simple “opt in” or “opt out” option, but this should not be a simple “yes” or “no”. Meaningful consent is required. describes meaningful consent as “when the patient makes an informed decision and the choice is properly recorded and maintained”. In addition, according to HHS, the meaningful consent should have the following six aspects in regard to a patient’s decision:

  • It must be made with full transparency and education
  • It must be made only after the patient has had sufficient time to review educational material
  • It must commensurate with circumstances for why health information is exchanged (i.e., the further the information-sharing strays from a reasonable patient expectation, the more time and education is required for the patient before he or she makes a decision)
  • It must not be used for discriminatory purposes or as a condition for receiving medical treatment
  • It must be consistent with patient expectations
  • It should be revocable at any time

Ironically, with many healthcare providers, patient consent is not obtained electronically, but through paper form. The Office of the National Coordinator for Health Information Technology (ONC) has put together a toolkit to encourage healthcare organizations and providers to offer patients the ability to provide meaningful consent, or non-consent, through technology.

There is a trial project for e-consent underway and it’s easily obtainable through the ONC’s e-consent toolkit. The toolkit is not an all-encompassing, straight out of the box, way for an organization to immediately implement e-consent. However, it does offer well-researched examples of how to implement a technological approach to meaningful consent. The ONC e-Consent Trial Project put together a way to gather a patient’s input on consent, educate them about eHIE, and capture and store this information electronically.

Consent Form Healthcare MedicaThe toolkit includes planning resources which include an example survey for patients to obtain what patients need to know before making a meaningful consent decision. The toolkit also contains educational materials, texts, and stories, and, of course, technical resources. The technical resources for providers includes a helpful eConsent Story Engine Tool which can display educational material to patients and allows for electronically capturing patients’ signatures.  Also, for implementers of the tool, there are video tutorials in regard to the e-Consent Story Engine Tool, architectural analysis and technical standards for computer software and hardware for the Story Engine installation on a web server, an installation guide, and a user guide.

As technology continues to evolve in the healthcare industry, just as meaningful consent is required from patients, it makes sense to utilize technology in a meaningful way. Utilizing helpful resources such as the ONC’s e-Consent Toolkit can help your organization lessen paperwork and redundancy. Data-Fast Solutions can help your organization utilize the e-Consent Toolkit and other technical resources to ensure your company is functioning more efficiently.

This article is ©2017 Data Fast Solutions • All Rights Reserved