Interoperability: Informed Consent for the real-world physician

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Consent is a controversial subject and has significant ramifications in the healthcare delivery system.

“Qui tacet consentire videtur “in Latin translates to "silence implies consent."

Consent is a controversial subject and has significant ramifications in the healthcare delivery system. Informed Consent is a HIPAA compliant document and meets the administrative, ethical and legal needs in the domain of patient autonomy. Informed Consent is implied by patient’s compliance documented by the physician. Express consent is recorded by a signature or verbally documented in the EHR.

Informed consent is acknowledged by physicians, surgeons, trial sponsors and patients before performing procedures and surgeries or enrolling in a clinical trial. Individual states mandate statutory forms for specific procedures and situations. The EHR is a tool for recording patient health information (PHI) including the. The Agency for Healthcare Research and Quality (AHRQ) has retained The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) to guide the development of an informed consent process across healthcare organizations. JCAHO provided a framework of eight safety actions for the informed consent process. The guidelines included a clear written policy, formal training and useful communication models. 

Shortcomings in informed consent with the integration of EHR and data capture

There is an intricate crosslink between the clinician and clinical research. The two fields span the digital web and are leaving digital imprints in EHRs, electronic data capture (EDC), machine learning algorithms, chatbots, and blockchain technologies. FDA issued regulations about using EDC and interoperability with EHR. Electronic Data Capture is a computerized system to collect clinical trial data in electronic format, in place of manual transcription from paper documents.

In July 2018, FDA provided guidelines for using EHR records and standardized and unstandardized data from patients, including demographics, radiology, and laboratory reports as electronic source documents. The EHR is the identifiable data originator of records. Personnel access for documentation for relevant trial visits is restricted. The EHR maintains an auditable time trail that is compliant with the updated certification requirements.

Application Programming Interface (API) securely communicate with the EHR and EDC. API’s capture authenticated data and transfer it from one interface to the next. Using the EHR patient encounters, EDC systems can auto-populate and generate source documents. The direct transfer of information reduces the errors of manual transcription, enabling cleaner data that is more cost- and time-effective.

A patient enrolled in a clinical trial has to sign the informed consent from the trial sponsor. With interoperability between the EHR and EDC, the patient has a unified identity across the two systems. To secure PHI, the trial sponsors must have access exclusively to the encounters related to the trial. Does the IC from the physician or clinical trial sponsor address this complex interoperability at the patient contact?

Shortcomings in informed consent with the integration of EHR - Real world evidence

A newer terminology, in clinical research, is real-world data (RWD) and real-world evidence (RWE). The additional data augments the current knowledge base. Controversies surround some regulatory aspects in clinical trial design. We derive RWE from aggregating and analyzing real-world data elements.

What are real-world data elements? They are a composite review and interpretation of data in the healthcare delivery system from sources like claims and billing activities, registries and data gathered from mobile devices.

The 21st-century Cures Act, passed in 2016, defined RWD and RWE. Real World Data is patient health information collected from sources outside of traditional clinical trials. Some sources of real-world data are EHRs, reimbursement claims, and billing, product and disease registries, patient-generated data in home use settings and mobile devices. Clinical evidence, collected by analysis of RWD, is called RWE. The interoperable use of this diversely owned data will improve quality outcomes. Clinical trial sponsors are highly motivated to use the data to make additional efficacy claims. 


The patient who is at the doctor’s visit has not signed a consent for the release of RWD.

The need to reformat Informed Consent

Healthcare providers and organizations own patient health information. Clinical trial sponsors have lobbied for the use and efficacy of using RWE in faster market claims of product use. FDA, the governing body for clinical trials, issued guidance in August 2017, for RWD evaluation for medical devices.  The guidance provides quality criteria for valid RWD and RWE. It does not propose an enforceable specific framework for regulatory decision making. The trials with RWE and RWD are called pragmatic trials.

Informed consent is signed by patients when they enroll in a clinical trial. However, with the interoperability between EHR and EDC and the advent of RWE, the physician-patient duo is summoned to inspect the “act of consenting “

In a web-based survey with 2,130 U.S. adults, more than 62 percent of respondents recommended written consents over general notification or verbal consent. The Get Real Consortium proposed four alternate informed consent models for pragmatic trials, as the traditional consent model used in randomized clinical trials (RCT) confounded the study due to the recruitment difficulties and selection bias. The four proposed alternative informed consent models are integrated consent, targeted consent, broadcast consent, and a waiver of consent. 

The new advances in PHI documentation command a relook at the components of IC. Are you thinking about the consent process” implied or express” or have you taken formidable steps? The cyber threat is predicted to be the number one healthcare technology hazard of 2019.

Real world ready consent 

A simple first step is to inform and educate patients with information on RWD through patient information booklets.

  • Draft an IC with the goals of the clinical practice and clinical research.
  • Does the practice intend to use PHI for data mining for improved clinical outcomes?
  • Does the practice intend to participate in pragmatic trials?

Counting on contemporaneous notes is wisdom. However, taking the first step for informing the patients is in the realm of a real-world physician. Are you one?

Nita K. Thingalaya, MD, is an internal medicine hospitalist with over 15 years’ experience as a practicing physician. She is currently medical director in healthcare utilization with experience in clinical research and informatics. The article is independent of her affiliations past or present.