Flat-fee HIPAA compliance representation for healthcare practices, digital health businesses, and HIPAA-regulated organizations. Privacy and security policy documentation, Business Associate Agreements, breach response planning, vendor compliance review, and the compliance infrastructure that fits how modern healthcare organizations actually operate.
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HIPAA — the federal Health Insurance Portability and Accountability Act — regulates how protected health information (PHI) is used, disclosed, secured, and protected by healthcare providers, health plans, and the business associates that handle PHI on their behalf. The regulatory framework has substantive components: the Privacy Rule (governing uses and disclosures of PHI), the Security Rule (governing electronic PHI security safeguards), the Breach Notification Rule (governing what happens when PHI is breached), and the Enforcement Rule (governing how violations are handled). HHS Office for Civil Rights (OCR) enforces HIPAA and has been increasingly active in enforcement, with substantial penalties for violations.
HIPAA compliance work involves both initial setup (getting the right policies, documentation, and procedures in place) and ongoing maintenance (updating policies as the organization changes, training staff, addressing breaches when they occur, handling compliance questions as they arise). The work varies substantially by organization type and size: a solo practitioner needs a basic compliance framework that fits their specific practice; a multi-location medical group needs more substantive policies and training; a digital health company that handles PHI as a business associate has its own specific compliance needs that include vendor management.
Most of our HIPAA work falls into a few patterns. New practice setup: getting a newly-formed practice or healthcare business HIPAA-compliant from launch. Compliance audit: reviewing an existing practice's HIPAA documentation and identifying gaps. Business Associate Agreements: drafting and reviewing the agreements between covered entities and their vendors that handle PHI. Breach response: when PHI is breached, addressing the notification requirements, OCR communications, and any related response. Digital health and technology compliance: HIPAA compliance for digital health platforms, telehealth providers, EHR vendors, and other technology businesses that handle PHI.
Scope note: We handle HIPAA compliance setup, documentation, and incident response as a transactional flat-fee service. We don't handle contested OCR enforcement litigation or class action defense — those matters require specialized healthcare litigation counsel and operate on different fee structures.
For new practices and healthcare-adjacent businesses, the HIPAA setup involves documenting the compliance framework. Standard items: Notice of Privacy Practices (the public-facing document explaining how the practice uses PHI), Privacy Policy (internal policies governing PHI uses and disclosures), Security Policy (electronic PHI security safeguards — administrative, physical, technical), Workforce Training procedures, Incident Response procedures, Patient Rights procedures (access requests, amendment requests, accounting of disclosures), and Business Associate Agreement templates. The documentation needs to fit how the practice actually operates rather than being generic boilerplate.
BAAs are contracts required between covered entities (providers, health plans) and the vendors that handle PHI on their behalf (cloud storage providers, billing services, IT vendors, transcription services, etc.). HIPAA requires specific provisions in BAAs, and a covered entity that allows a vendor to handle PHI without a compliant BAA is itself in violation of HIPAA. We draft and review BAAs for both sides — covered entities entering BAAs with vendors, and business associates entering BAAs with covered entities. Many BAAs in the market are heavily one-sided toward the drafting party; substantive review and negotiation is often appropriate.
For existing practices that want to evaluate their HIPAA posture, we conduct compliance audits covering the documentation, the actual operational practices, and the vendor relationships. The audit identifies gaps — common issues include outdated Notices of Privacy Practices, missing BAAs with vendors handling PHI, inadequate security safeguards, and gaps in training documentation. The audit produces a written report and a prioritized remediation plan.
When a HIPAA breach occurs (unauthorized access, disclosure, or loss of PHI), the response involves specific notification obligations to affected individuals, HHS, and (for larger breaches) the media. The notification timing and content are prescribed by the Breach Notification Rule. The response also involves investigating the breach, documenting the incident, addressing any contributing causes, and coordinating with OCR if OCR opens an investigation. We handle breach response work — assessment of whether an incident qualifies as a reportable breach, notification preparation and execution, OCR coordination, and post-breach remediation.
Digital health platforms, telehealth providers, EHR vendors, health-data companies, and various other technology businesses that handle PHI have specific HIPAA compliance considerations. The business model often determines whether the company is a covered entity, a business associate, or both, and the compliance requirements differ accordingly. Specific issues for digital health businesses include vendor compliance (the digital health platform's own vendors handling PHI), patient access (HIPAA right of access requirements for patient-facing platforms), authorization and consent flows (digital interfaces for HIPAA authorizations), and de-identification (if the company uses de-identified data for analytics or commercialization).
HIPAA is federal baseline; NY has its own privacy and security requirements that often go beyond HIPAA. NY's SHIELD Act imposes data security requirements that apply broadly to entities handling NY residents' private information. NY Mental Health Law and other state statutes have specific requirements for certain types of healthcare data (mental health records, HIV/AIDS records, substance abuse records, genetic information). Compliance work needs to address both federal HIPAA requirements and NY-specific overlays.
Telehealth has expanded substantially in recent years, and the regulatory framework for telehealth providers includes HIPAA compliance, NY-specific telehealth regulations, multi-state licensure considerations (for providers seeing patients across state lines), and various technology-specific compliance issues. We address telehealth compliance as a specific area within broader HIPAA work for practices and platforms offering telehealth services.
All work is flat-fee, set in writing before any work begins. Standard practice HIPAA setup (Notice of Privacy Practices, internal policies, BAA template, training materials) prices predictably. Compliance audits price as defined-scope project engagements. Individual BAA reviews price modestly per agreement. Breach response work prices based on scope — single-incident response varies substantially with the breach size and complexity.
For digital health businesses and healthcare technology companies, HIPAA compliance is typically structured as part of broader business legal work given how integrated compliance is with the business model. We coordinate HIPAA-specific work with broader entity formation and commercial work.
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Yes — for any practice or business handling PHI. HIPAA requires documented policies and procedures, and OCR enforcement focuses substantially on whether organizations can produce their HIPAA documentation when asked. Practices operating without documented policies face higher risk in any compliance review (whether prompted by a complaint, a breach, or an audit). The documentation also serves operational purposes — clear policies help staff understand what they should and shouldn't do, which prevents many violations in the first place.
A Business Associate Agreement (BAA) is a contract required between a covered entity (provider, health plan) and a vendor that handles PHI on its behalf. Common situations requiring BAAs: cloud storage providers storing patient records, billing services accessing patient information, IT vendors with access to systems containing PHI, transcription services, electronic health records vendors, and various other vendors whose work involves PHI. A covered entity that allows a vendor to access PHI without a compliant BAA is itself in violation of HIPAA, regardless of whether the vendor mishandles the data. BAAs are required even when the vendor is well-known and otherwise compliant — the contract itself is required.
The Breach Notification Rule requires specific notification depending on the breach scope. For breaches affecting fewer than 500 individuals, the covered entity must notify the affected individuals within 60 days, log the breach for annual reporting to HHS, and address the underlying issues. For breaches affecting 500 or more individuals, additional notification to HHS within 60 days, prominent media notification in the affected area, and immediate public reporting are required. The response also involves investigating the breach, addressing root causes, and (when OCR opens an investigation) responding to OCR inquiries. We handle breach response work — assessment, notification, OCR coordination, and remediation.
Depends on what the app does and who uses it. Apps that interact directly with patients and store health information collected by the patient generally aren't subject to HIPAA — they may be subject to other privacy laws (state privacy laws, FTC privacy rules for health apps, GDPR for European users) but typically aren't HIPAA-regulated unless they're providing services on behalf of a covered entity. Apps that integrate with healthcare providers, store data on behalf of providers, or provide services that handle PHI from covered entities typically are HIPAA-regulated as business associates. The analysis is fact-specific and matters substantially for compliance planning.
HIPAA is federal baseline for healthcare privacy and security. NY adds additional requirements that often go beyond HIPAA. NY's SHIELD Act imposes data security requirements that apply to any entity handling NY residents' private information, including health information. NY Mental Health Law has additional protections for mental health records. NY's HIV confidentiality law has specific protections for HIV-related information. NY's Article 27-F protects genetic information. Compliance work needs to address both federal HIPAA requirements and NY-specific overlays, particularly for practices handling sensitive health categories.
Flat fee set in writing before any work begins. Standard practice setup prices predictably; compliance audits and breach response price based on scope. Get a free quote in under an hour by submitting the contact form.
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