QC Healthcare

QC Healthcare welcomes the U.S. Food and Drug Administration’s effort to establish a thoughtful, risk-based regulatory framework for generative artificial intelligence-enabled medical devices. Across QC Healthcare and all current and future healthcare platforms, we believe AI can meaningfully improve access, clinical efficiency, care coordination, medical research, and patient outcomes. The United States should remain at the forefront of responsible healthcare innovation while ensuring that the speed of technological advancement never outpaces patient safety.

AI should be used to strengthen healthcare professionals—not indiscriminately replace their clinical judgment. Low-risk administrative functions, including scheduling, documentation assistance, workflow management, patient navigation, and certain operational communications, should benefit from appropriate automation. Clinical applications, however, must be regulated according to the seriousness of the decision, the vulnerability of the patient, and the potential consequences of an error.

AI-supported diagnosis and differential diagnosis, prescribing and medication changes, treatment planning, referrals, emergency triage, and escalation decisions should always require review and approval by a licensed clinician. Decisions involving pediatric patients and other vulnerable populations must be subject to stricter validation standards and enhanced human oversight. AI may inform these decisions, but responsibility for higher-risk care must remain with an appropriately qualified healthcare professional.

ENFORCEABLE GUARDRAILS—NOT VOLUNTARY PRINCIPLES

A credible regulatory framework should require each of the following:

• Independent premarket testing and recurring third-party audits;

• Permanent, tamper-resistant decision logs showing the inputs used, outputs generated, actions taken, model version involved, and individuals responsible for review;

• Clear patient disclosure when AI materially influences care, accompanied by meaningful consent where appropriate;

• Continuous monitoring for accuracy, bias, cybersecurity vulnerabilities, model drift, and unequal outcomes among patient populations;

• Mandatory incident reporting and defined procedures for immediately disabling, rolling back, or recalling unsafe AI functions; and

• Meaningful financial penalties, corrective-action requirements, and FDA enforcement when developers or healthcare organizations fail to meet these obligations.

LIFECYCLE MONITORING AND ACCOUNTABLE OWNERSHIP

Oversight must continue throughout the full life cycle of an AI system. A model that performed safely during its original evaluation may change because of software updates, new data, changes to an underlying foundation model, altered clinical environments, or expanding agentic capabilities. Every material change should be documented, assessed, and—when it could affect clinical performance or patient safety—independently revalidated before broader deployment.

Responsibility must also be clearly assigned. Technology developers, medical-device manufacturers, healthcare organizations, and clinical users should not be permitted to shift accountability to one another following an adverse event. Each participant should have defined legal and operational responsibilities governing validation, deployment, monitoring, cybersecurity, clinician training, patient disclosure, and incident response.

PATIENT RIGHTS AND PUBLIC TRUST

Patients must retain meaningful rights within an AI-enabled healthcare system. They should be able to understand when AI materially influences their care, request appropriate human review, correct inaccurate information, and report concerns without losing access to treatment. Transparency must be understandable to patients and clinicians—not buried within technical documentation or lengthy terms of service.

QC Healthcare supports innovation that expands access and enables clinicians to deliver safer, faster, and more informed care. Public trust, however, will depend on whether the nation establishes clear boundaries, measurable standards, independent oversight, and meaningful consequences when those standards are violated.

The proper goal is not to prevent healthcare AI from advancing. It is to ensure that innovation advances with accountability, transparency, clinical responsibility, and patient safety built into its foundation. QC Healthcare looks forward to contributing its perspective and working with the FDA, federal policymakers, clinicians, patients, and technology developers to establish a durable framework for the responsible use of AI in American healthcare.

Respectfully submitted,

Eric Doherty
Chief Executive Officer
QC Healthcare
8350 Arrowridge Boulevard, Suite 1A-9
Charlotte, North Carolina 28273
Telephone: 678-448-6776
Email: ericdoherty@qchealthcaregroup.com

QC Healthcare
8350 Arrowridge Boulevard, Suite 1A-9
Charlotte, North Carolina 28273

From the Desk of Eric Doherty, CEO

August 28, 2026

Dockets Management Staff (HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852

RE: Executive Statement on the Responsible Regulation of Generative AI-Enabled Medical Devices

Docket: FDA-2026-N-7874

To Acting Commissioner Kyle Diamantas, Director Michelle Tarver, Director Rick Abramson, and Federal Health
Policymakers:

QC Healthcare welcomes the U.S. Food and Drug Administration’s effort to establish a thoughtful, risk-based regulatory
framework for generative artificial intelligence-enabled medical devices. Across QC Healthcare and all current and
future healthcare platforms, we believe AI can meaningfully improve access, clinical efficiency, care coordination,
medical research, and patient outcomes. The United States should remain at the forefront of responsible healthcare
innovation while ensuring that the speed of technological advancement never outpaces patient safety.

AI should be used to strengthen healthcare professionals—not indiscriminately replace their clinical judgment. Low-risk
administrative functions, including scheduling, documentation assistance, workflow management, patient navigation,
and certain operational communications, should benefit from appropriate automation. Clinical applications, however,
must be regulated according to the seriousness of the decision, the vulnerability of the patient, and the potential
consequences of an error.

AI-supported diagnosis and differential diagnosis, prescribing and medication changes, treatment planning, referrals,
emergency triage, and escalation decisions should always require review and approval by a licensed clinician. Decisions
involving pediatric patients and other vulnerable populations must be subject to stricter validation standards and
enhanced human oversight. AI may inform these decisions, but responsibility for higher-risk care must remain with an
appropriately qualified healthcare professional.

ENFORCEABLE GUARDRAILS—NOT VOLUNTARY PRINCIPLES

A credible regulatory framework should require each of the following:

• Independent premarket testing and recurring third-party audits;

• Permanent, tamper-resistant decision logs showing the inputs used, outputs generated, actions taken, model version
involved, and individuals responsible for review;

• Clear patient disclosure when AI materially influences care, accompanied by meaningful consent where appropriate;

• Continuous monitoring for accuracy, bias, cybersecurity vulnerabilities, model drift, and unequal outcomes among
patient populations;

EricDoherty@QCHealthCareGroup.com
678.448.6776 8350 Arrowridge Blvd. Ste. 1A-9
Charlotte, NC 28273
QCCapitalGroup.com
• Mandatory incident reporting and defined procedures for immediately disabling, rolling back, or recalling unsafe AI
functions; and

• Meaningful financial penalties, corrective-action requirements, and FDA enforcement when developers or healthcare
organizations fail to meet these obligations.

LIFECYCLE MONITORING AND ACCOUNTABLE OWNERSHIP

Oversight must continue throughout the full life cycle of an AI system. A model that performed safely during its original
evaluation may change because of software updates, new data, changes to an underlying foundation model, altered
clinical environments, or expanding agentic capabilities. Every material change should be documented, assessed, and—
when it could affect clinical performance or patient safety—independently revalidated before broader deployment.

Responsibility must also be clearly assigned. Technology developers, medical-device manufacturers, healthcare
organizations, and clinical users should not be permitted to shift accountability to one another following an adverse
event. Each participant should have defined legal and operational responsibilities governing validation, deployment,
monitoring, cybersecurity, clinician training, patient disclosure, and incident response.

PATIENT RIGHTS AND PUBLIC TRUST

Patients must retain meaningful rights within an AI-enabled healthcare system. They should be able to understand when
AI materially influences their care, request appropriate human review, correct inaccurate information, and report
concerns without losing access to treatment. Transparency must be understandable to patients and clinicians—not buried
within technical documentation or lengthy terms of service.

QC Healthcare supports innovation that expands access and enables clinicians to deliver safer, faster, and more informed
care. Public trust, however, will depend on whether the nation establishes clear boundaries, measurable standards,
independent oversight, and meaningful consequences when those standards are violated.

The proper goal is not to prevent healthcare AI from advancing. It is to ensure that innovation advances with
accountability, transparency, clinical responsibility, and patient safety built into its foundation. QC Healthcare looks
forward to contributing its perspective and working with the FDA, federal policymakers, clinicians, patients, and
technology developers to establish a durable framework for the responsible use of AI in American healthcare.

Respectfully submitted,

Eric Doherty
Chief Executive Officer
QC Healthcare
8350 Arrowridge Boulevard, Suite 1A-9
Charlotte, North Carolina 28273
Telephone: 678-448-6776
Email: ericdoherty@qchealthcaregroup.com

EricDoherty@QCHealthCareGroup.com
678.448.6776 8350 Arrowridge Blvd. Ste. 1A-9
Charlotte, NC 28273
QCCapitalGroup.com
EricDoherty@QCHealthCareGroup.com
678.448.6776 8350 Arrowridge Blvd. Ste. 1A-9
Charlotte, NC 28273
QCCapitalGroup.com