Achieving patient consent through email and text messaging involves using these channels to send detailed consent forms and informational materials directly to patients. These digital forms can clearly explain the purpose of the proposed medical intervention or data sharing, outline the risks and benefits, and provide an easy, secure way for patients to ask questions.
Understanding informed consent
“Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process.”
The above extract from a 2023 study, provides insight into the nature of informed consent. Consent itself represents a principle in medical ethics and legal frameworks. Informed consent goes a step further, requiring healthcare providers to give patients all the relevant information about the benefits, risks, and alternatives to a proposed treatment or procedure. This process is not only about respecting patient autonomy but also about protecting healthcare organizations legally and ethically. The need for consent extends into healthcare communications, particularly with the advent of digital technologies like HIPAA compliant email and text messaging.
See also: Patient consent: What you need to know
When is informed patient consent necessary
- Before starting treatment
- Prior to surgical procedures
- During clinical trials
- When sharing phi for purposes beyond direct care
- Before administering vaccinations
- When implementing Do Not Resuscitate (DNR) orders
- In the use of telemedicine services
- Before non-emergency telehealth sessions
- For high-risk screenings and tests
- When changing the treatment plan
The legislation that applies to patient consent in texting and email
HIPAA applies directly to how healthcare organizations handle patient data and specifically obtain patient consent when using that data for marketing purposes. The TCPA coincides with HIPAA by requiring, all business including those in the healthcare sector, first gain consent before sending promotional text messages. The legislative requirements include:
- Explicit and informed consent: Both HIPAA and TCPA require that the consent must be explicit and informed. This means patients must be clearly informed about how their information will be used, to whom it will be disclosed, and they must explicitly agree to this use or disclosure.
- Opt-in mechanism: For text messaging under the TCPA, this typically involves an opt-in mechanism where the patient actively agrees to receive text messages, often by texting a keyword to a short code or signing a form.
- Documentation: Consent must be documented and maintained by the healthcare provider. For HIPAA, this could be part of the patient's health records. For TCPA, records of consent to receive text messages or calls should be kept to protect against compliance allegations.
- Revocation of consent: Patients must be informed about how they can revoke their consent at any time and reasonable means must be provided for them to do so.
The characteristics of valid patient consent
Based on a Nursing Ethics study the following can be said for valid patient consent: “Patient decision-making capacity (DMC) is arguably the central tenet of all healthcare consents, and a consent which is devoid of DMC is not legally valid. Increasing evidence suggests the presence of healthcare practitioner (HCP) dissonance and variation in practice in the assessment of patient DMC, which has an impact on subsequent consent and treatment frameworks. A legal and ethical responsibility exists for HCPs to obtain a valid consent for all healthcare treatments…”
Without understanding the gravity of their consent and how it will impact them, patients cannot validly consent to anything. The requirements for valid consent include:
- Valid patient consent must be informed, with all necessary information about treatment options, benefits, risks, and alternatives provided.
- It should be given voluntarily, without coercion or undue influence.
- The consent must come from a patient who is competent and has the mental capacity to make healthcare decisions.
- Consent needs to be specific to the particular treatment or procedure.
- Patients must have the opportunity to ask questions and receive satisfactory answers.
- Consent should be documented according to legal and medical standards.
- It can be withdrawn by the patient at any time before the treatment.
How to ethically and legally obtain consent
- Use of clear, simple language in consent forms: Develop consent forms and any explanatory materials using simple, non-technical language that is easily understandable by all patients.
- Develop a HIPAA compliant consent form: Create a consent form that clearly outlines the intent behind using email and text messaging for communication. By leveraging Paubox Forms, healthcare providers can efficiently create, distribute, and collect informed consent forms.
- Provide a Notice of Privacy Practices (NPP): Before seeking consent, ensure patients are given an NPP that thoroughly explains how their PHI will be utilized and disclosed.
- Accessibility options for diverse patient needs: Ensure consent forms and educational materials are accessible to patients with disabilities. Offer materials in large print, braille, or audio formats, and make sure digital consent platforms are compatible with screen readers.
- Consent confirmation follow-up: After obtaining consent, conduct a follow-up via a phone call or secure message to confirm the patient's understanding and consent.
- Offer options for customizing communication preferences: During the consent process, allow patients to customize their communication preferences, such as the type of information they wish to receive via text message or email and the frequency of messages.
See also: Top 12 HIPAA compliant email services
FAQs
Is verbal consent sufficient for texting and emailing patients?
While verbal consent may be legally acceptable in some cases, written consent is preferable for clarity and documentation purposes. It's important to follow your jurisdiction's specific legal requirements and best practices.
How should healthcare providers document and manage patient consents?
Providers should maintain secure records of consent forms or documentation, whether in paper or electronic format, and have systems in place to easily access and verify consent status.
What should be done if there's a breach in communication security?
In case of a breach, healthcare providers must follow the required breach notification procedures under laws like HIPAA, which include notifying affected patients, relevant authorities, and possibly taking steps to mitigate the breach's effects.
Kirsten Peremore
