The Impact of Informed Consent – Part 1: Compliance

Informed Consent: Letting Go of the Status Quo

Anyone working in a healthcare setting (and most patients as well) knows the importance of the process of informed consent.

Ultimately, the goal of informed consent is:

  • for the patient to be an educated participant in his/her healthcare decision,
  • to provide evidence of consent that serves to document their legal and ethical responsibility (The Joint Commission, 2016).

It shouldn’t surprise you that when the process of capturing consent falls short, it opens a door of legal risks, compliance, patient safety, and operational issues. But, does it surprise you to learn that ¾ of organizations still use paper forms to document the critical process of informed consent vs. leveraging electronic signature technology?

While consent is more than a signature, the way the consent is documented on a form is extremely important. Failure to obtain informed consent is one of the top ten reasons why medical malpractice claims are filed against hospitals.

While the healthcare industry is embracing paperless automation via EHR systems, they are realizing the critical process of informed consent is not addressed by EHR solutions.

The inefficiencies inherent to paper-based consent form processes can result in missing or improperly scanned forms. This produces delays and inconsistencies, drains the valuable time of clinicians, exposes hospitals to risk, and ultimately, impact patient safety.

For many health systems, improving the informed consent process has become integral to a proactive approach to key strategic initiatives such as patient experience, cost savings, and risk management.

FormFast’s Mobile eConsent solution addresses the industry’s growing need for a more streamlined, reliable, and consistent informed consent process and provides an alternative to the error-prone, paper-based process.

With FormFast’s Mobile eConsent Solution, consents are quickly signed by the patient, immediately archived, and instantly visible to the care team. FormFast prevents lost documents, expedites care, and keeps healthcare organizations in compliance.


This 4-part blog series will take a deeper look into 4 key areas impacted by the informed consent process: Compliance, Satisfaction, Cost, and Productivity to further examine why its time to let go of the status quo when it comes to informed consent.

Let’s start with an important one: compliance.


Informed Consent’s Impact on Compliance: Legal & Ethical Implications of Missing Consent Forms

Physicians and other clinicians have a legal and ethical responsibility to discuss the risks and benefits of a procedure with patients. But, clinicians may not provide enough educational information to patients, document these conversations appropriately, or even misplace proof [the consent form] that this conversation took place, exposing themselves and the hospital to a myriad of compliance and legal problems.

Audit Failures: Since informed consent documents are frequently lost, healthcare organization often fail The Joint Commission audits. In fact, 500+ healthcare organizations experience compliance issues with The Joint Commission each year due to missing consent forms.

Increased Liability: Missing consents also increase risk and liability in the instance of malpractice claims. With 2/3 of malpractice cases citing lack of informed consent, legal and risk management leaders are taking a special notice of the process.

An eye-opening study from JAMA Surgery found that, missing consent forms occurred in 66% of procedures. These missing forms are estimated to delay 10% of surgeries and can cost hospitals over $500,000 each year.

Paper-based consent forms can lead to several negative impacts that can cost an organization money and time, and in some cases, their reputation – which in the healthcare industry is worth its weight in gold. Can your hospital afford the legal risks of missing consent forms?


The good news? Missing, misplaced, or incomplete informed consent forms and the compliance risks associated are a thing of the past with FormFast.

By automating the process of informed consent with FormFast, you are ensuring access to the right consent, for the right patient, at the right time. The consent is archived in the correct place and the right members of the care team have visibility to the documentation when they need it.

With an electronic process, validation occurs within the system and ensures all fields are filled out appropriately, paving the way for a much better situation to ensure compliance. With FormFast, the language to describe the risks, benefits, and alternatives to every procedure is standardized, which ensures that conversations with patients follow a template approved by the hospital’s legal team. There is also the option to link to additional educational content – further ensuring patients are truly educated of their care plans.

Combining the power of technology with the critical process of informed consent is a small change, that produces big results and impacts key areas ripe for improvement, such as compliance.

See why today’s leading healthcare organizations are turning to FormFast to automate the critical process of informed consent

Stay Tuned for Part 2: Examining Informed Consent’s Impact on Satisfaction