21st Century Cures Act: Impact on Wound Care Documentation

21st Century Cures Act and Wound Care Documentation

The 21st Century Cures Act reshaped how wound care providers handle clinical documentation, patient access, and health information exchange. Signed in 2016 with key provisions taking effect in 2021 and beyond, the Cures Act established information blocking rules that directly affect how wound care practices store, share, and provide access to clinical records. For wound care providers who generate detailed visit notes, wound photographs, and treatment plans, understanding these requirements is not optional --- it is a compliance obligation with enforcement authority behind it.

The information blocking provisions are particularly relevant to wound care because this specialty generates documentation that patients increasingly want to see: wound progress photographs, measurement trends, and treatment rationale. The Cures Act says patients have a right to access this information without delay, and providers who create unnecessary barriers face penalties.

Information Blocking Rules for Wound Care Providers

The Cures Act defines information blocking as a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. For wound care practices, this means you cannot restrict patient access to their clinical records except under narrowly defined exceptions.

What Constitutes Information Blocking

Information blocking in wound care can take forms that practices may not recognize as violations:

Delaying access to visit notes. If your wound care documentation system generates notes that are electronically available but you impose a waiting period before patients can view them --- for example, holding notes for physician review before release --- this may constitute information blocking. The Cures Act requires that electronic health information be available to patients without unnecessary delay.

Restricting access to wound photographs. Wound photographs are part of the clinical record. Refusing to share wound images through a patient portal or requiring patients to submit formal records requests for photographs they could access electronically constitutes information blocking if the images are available in your EHR.

Charging fees for electronic access. Charging patients for electronic access to their health information through a portal or API violates the Cures Act. You may charge reasonable cost-based fees for paper copies, but electronic access must be free.

Using non-standard formats. If your system can export health information in standard formats (FHIR, C-CDA) but you only provide information in proprietary formats that other systems cannot read, this can constitute information blocking. Wound care practices that use specialty EHRs must ensure their systems support standard interoperability.

The Eight Exceptions

The Cures Act provides eight exceptions where restricting information access is permitted. The exceptions most relevant to wound care include:

Privacy exception. You may restrict access when required by federal or state privacy laws (HIPAA, state mental health protections) or when the patient has not consented to electronic access. This does not mean you can broadly deny portal access --- it applies to specific, documented privacy concerns.

Security exception. You may restrict access when necessary to protect the security of electronic health information, such as during a system breach or when access methods pose cybersecurity risks.

Preventing harm exception. You may delay access to information when a licensed healthcare professional determines, in their professional judgment, that the information could cause substantial harm to the patient or another person. In wound care, this exception is rarely applicable but could arise in cases involving wound care related to self-harm or abuse.

Open Notes and Wound Care Documentation Practices

The OpenNotes provisions of the Cures Act mean that patients can read your wound care visit notes as soon as they are filed in the EHR. This has practical implications for how wound care clinicians document.

Writing Notes Patients Will Read

Wound care documentation has always been clinical and technical --- wound bed tissue percentages, debridement techniques, LCD compliance narratives. With open notes, patients now read these descriptions of their own wounds. Practices should consider:

Use clear language alongside clinical terminology. You do not need to eliminate medical terminology, but adding brief plain-language explanations helps patients understand their care. "Wound bed shows 60% granulation tissue (healthy healing tissue) and 40% fibrinous slough (tissue that needs to be removed)" is both clinically precise and patient-accessible.

Be accurate about prognosis. Patients reading their wound care notes will see your clinical assessments of healing trajectory. Document honestly but thoughtfully. Phrases like "wound is not responding to current treatment plan" are clinically appropriate and help patients understand when treatment changes are warranted.

Document medical necessity clearly. When patients read notes that include medical necessity language for LCD compliance, they gain insight into why specific treatments were chosen. This transparency can strengthen the patient-provider relationship and improve treatment adherence. For more on patient engagement through portals, see the patient portal engagement guide.

Patient Portal Requirements for Wound Care

The Cures Act, combined with CMS Promoting Interoperability requirements, means wound care practices need functional patient portal capabilities. The specific requirements include:

Timely access to clinical notes. Visit notes, including wound assessments, treatment plans, and procedure documentation, must be available through the portal without unnecessary delay after filing.

Access to lab results and diagnostic reports. Wound cultures, vascular studies (ABI results), and other diagnostic information must be accessible through the portal.

FHIR API availability. Certified EHR systems must support FHIR R4 APIs that allow patients and authorized third-party applications to access health information. If your wound care EHR is ONC-certified, it must provide this capability.

Wound photographs. If wound photographs are stored in your EHR, they are part of the designated record set and must be accessible to patients. This is a common gap in wound care practices --- photographs may be captured and stored but not surfaced through the patient portal.

Practices using wound care specialty software should verify that their system meets these requirements. Not all wound care EHRs have implemented full Cures Act compliance, and the responsibility falls on the provider regardless of software limitations. For HIPAA considerations in mobile wound care, see the HIPAA compliance guide for mobile practices.

Interoperability and Care Coordination

The Cures Act's interoperability provisions affect wound care practices that coordinate with primary care providers, home health agencies, and skilled nursing facilities.

Health Information Exchange Requirements

Wound care practices must be able to share clinical information electronically with other providers involved in the patient's care. This includes:

Sending wound care visit summaries to referring providers
Sharing wound progress data with care coordination teams
Responding to electronic records requests from other treating providers within the required timeframes

Practices that rely on faxing wound care notes to referring providers are not violating the Cures Act per se, but they should be building toward electronic exchange capabilities. The regulatory trajectory clearly favors electronic interoperability, and practices that invest in this capability now will be better positioned as standards tighten.

Key Takeaways

The 21st Century Cures Act prohibits information blocking, meaning wound care practices cannot delay or restrict patient access to visit notes, wound photographs, or treatment plans available in their EHR
Open notes requirements mean patients read your wound care documentation --- write notes that are both clinically precise and patient-accessible
Wound photographs stored in your EHR are part of the designated record set and must be accessible through patient portals
Eight exceptions allow limited information restrictions, but none broadly permit withholding wound care documentation from patients
Practices should verify that their wound care EHR supports FHIR R4 APIs and meets ONC certification requirements for Cures Act compliance