What to Do if Your Small Practice Receives a HIPAA Investigational Subpoena (45 CFR § 160.314)

Executive Summary

Receiving a HIPAA investigational subpoena can be alarming, especially for small healthcare practices unfamiliar with formal regulatory inquiries. Under 45 CFR § 160.314, the Office for Civil Rights (OCR) has authority to issue subpoenas to compel access to records, testimony, and other evidence during a HIPAA investigation. How your practice responds can determine whether the situation escalates into enforcement or resolves informally. This guide outlines what to expect, how to comply with federal subpoena authority, and practical steps for protecting your practice while remaining cooperative and legally compliant.

Introduction

Most small healthcare practices operate with minimal legal encounters. But when the U.S. Department of Health and Human Services (HHS), through OCR, issues a subpoena under § 160.314, it signals a formal escalation of a HIPAA investigation. The subpoena could relate to a patient complaint, a potential breach, or a compliance review.

Understanding the legal basis of these subpoenas and responding appropriately is critical. Missteps like ignoring the request, destroying documents, or responding incompletely can lead to civil monetary penalties or even criminal exposure. This article breaks down what investigational subpoenas mean, how they differ from informal requests, and how small practices should respond when they arrive.

Understanding § 160.314: Subpoena Authority Under HIPAA

Under 45 CFR § 160.314, OCR may issue subpoenas during investigations, compliance reviews, or hearings under the HIPAA Enforcement Rule. The regulation states:

“The Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of any other evidence during the course of any investigation or compliance review under this part.”

This authority includes the power to require:

• Testimony from employees or agents
• Production of policies, procedures, logs, or internal communications
• Electronic health records and access logs
• Audit trails and security incident reports

Failure to respond to an investigational subpoena may result in:

• Contempt proceedings in federal court
• Escalated enforcement action by OCR
• Inference of noncooperation, which may increase penalties

What a HIPAA Investigational Subpoena Looks Like

OCR subpoenas are usually delivered by mail, certified mail, or in person. They typically include:

• A cover letter explaining the investigation’s scope
• A formal subpoena document referencing § 160.314
• Instructions for producing documents or appearing for testimony
• Deadlines for response
• Contact information for the OCR investigator

A Case Study: Ignoring an OCR Subpoena Led to Escalation

In 2020, a small orthopedic clinic received a subpoena from the Office for Civil Rights (OCR), requesting access logs, breach documentation, and other records. The request followed a patient complaint alleging that a former clinic employee had accessed medical records without authorization, a clear potential HIPAA violation. Despite the subpoena being a formal investigative tool, the clinic hesitated to respond. Uncertain whether the request was enforceable or required immediate action, they delayed for over 30 days without providing the requested documents or even acknowledging the inquiry.

OCR sent multiple follow-up communications, but the clinic failed to comply or seek legal guidance. Eventually, OCR escalated the matter by petitioning the U.S. District Court to enforce the subpoena. The court ruled in OCR’s favor, ordering the clinic to comply and imposing sanctions for obstructing the investigation. The legal action resulted in reputational damage, a $75,000 settlement, and a mandatory corrective action plan. The clinic was also placed under one year of compliance monitoring, requiring regular reports and proof of corrective training and policy updates.

This case demonstrates the serious consequences of disregarding OCR subpoenas. Covered entities must treat all OCR inquiries with urgency and ensure timely, well-documented responses to avoid enforcement actions and penalties.

Immediate Steps to Take When You Receive a HIPAA Subpoena

Step 1: Review and Verify the Subpoena

• OCR or HHS letterhead
• Case number or file reference
• Clear identification of the information or testimony requested
• Deadline for compliance

Step 2: Notify Internal Stakeholders and Legal Counsel

• Alert your practice’s Privacy Officer, Compliance Officer, or attorney. Do not attempt to respond alone. Legal counsel can help:
  • Interpret the subpoena scope
  • Assess privileges or objections
  • Prepare formal correspondence
  • Supervise document production

Step 3: Preserve All Relevant Records

• Immediately implement a litigation hold to prevent deletion, alteration, or destruction of relevant documents. This includes:
  • Paper files
  • EHR data
  • Email communications
  • Security logs
• Failure to preserve evidence can be interpreted as obstruction.

Step 4: Gather and Review Responsive Materials

• Work with your compliance lead and legal team to:
  • Identify all documents responsive to the subpoena
  • Confirm completeness and accuracy
  • Remove privileged or irrelevant information, if appropriate
  • Maintain a copy of everything produced

Step 5: Respond by the Deadline

• Submit all required materials by the specified date. If you need more time, contact the OCR investigator immediately and request an extension in writing.

Common Pitfalls When Responding to HIPAA Subpoenas

• Delaying response due to uncertainty or fear
• Failing to engage legal counsel early in the process
• Destroying or modifying documents after receiving the subpoena
• Producing incomplete or disorganized information
• Over-disclosing PHI beyond the subpoena’s scope

Expert Tips for Small Practices

• Create a HIPAA subpoena response protocol in advance
• Train your front desk and administrative team on how to escalate legal requests
• Assign a point person, typically your Privacy Officer, to handle OCR correspondence
• Maintain a disclosure log with each subpoena response
• Avoid informal communication with OCR unless cleared by legal counsel

Checklist: How to Respond to a HIPAA Investigational Subpoena

Regulatory References and Official Guidance

• 45 CFR § 160.314 – Subpoenas in HIPAA Investigations
• HIPAA Enforcement Rule – 45 CFR §§ 160.300–160.426
• OCR Subpoena Enforcement Policy – HHS.gov
• HIPAA Security Rule Documentation Requirements
• Litigation Holds and Record Retention Under HIPAA
• OCR Resolution Agreements and Enforcement Actions

Concluding Recommendations and Next Steps

HIPAA investigational subpoenas are not routine occurrences, but when they are issued, they carry the full weight of legal authority. For small healthcare practices, misunderstanding or ignoring such subpoenas can quickly escalate a regulatory inquiry into a costly enforcement action. Under 45 CFR § 160.314, the Office for Civil Rights (OCR) has the power to compel compliance through administrative means or by seeking enforcement through federal court. Failure to respond properly can result in financial penalties, reputational harm, and long-term compliance obligations.

To minimize risk and maintain trust with regulators, small practices must act promptly and strategically. Always take subpoenas seriously, regardless of how informal the communication may appear. Involve legal counsel immediately to interpret the scope and legality of the request. Preserve all relevant documentation and electronic records to ensure nothing is lost or destroyed. Most importantly, respond by the deadline and document every step you take.

By establishing a response plan in advance and maintaining open communication with OCR, small practices can meet legal obligations without panic or confusion. A proactive, transparent approach not only reduces the risk of penalties but also demonstrates good faith and professionalism, which can influence how OCR chooses to resolve the matter.