Contact Us
Categories
- Workplace Violence
- Assisted Living Facilities
- Department of Health and Human Services' Office of Civil Rights
- Medical Residents
- EMTALA
- FDA
- Reproductive Rights
- Roe v. Wade
- SCOTUS
- Medical Spas
- medical billing
- No Surprises Act
- Mandatory vaccination policies
- Workplace health
- Coronavirus Aid, Relief and Economic Security Act
- Code Enforcement
- Department of Labor ("DOL")
- Employment Law
- FFCRA
- CARES Act
- Nursing Home Reform Act
- COVID-19
- SB 150
- Acute Care Beds
- Clinical Support
- Coronavirus
- Emergency Medical Services
- Emergency Preparedness
- Families First Coronavirus Response Act
- Family and Medical Leave Act (“FMLA”)
- KBML
- medication assisted therapy
- Department of Health and Human Services
- Legislative Developments
- Corporate
- United States Department of Justice ("DOJ")
- Employee Contracts
- Non-Compete Agreement
- Opioid Epidemic
- Sexual Harassment
- Health Resource and Services Administration
- Litigation
- Medical Malpractice
- House Bill 333
- Senate Bill 79
- Locum Tenens
- Physician Prescribing Authority
- Senate Bill 4
- Chronic Pain Management
- HIPAA
- Prescription Drugs
- "Two Midnights Rule"
- 340B Program
- EHR Systems
- Hospice
- ICD-10
- Kentucky minimum wage
- Minimum wage
- Primary Care Physicians ("PCPs")
- Skilled Nursing Facilities (“SNFs”)
- Uncategorized
- Affordable Insurance Exchanges
- Drug Screening
- Electronic Health Records (“EHR")
- Fraud
- Health Care Fraud
- HIPAA Risk Assessment
- KASPER
- Kentucky’s Department for Medicaid Services
- Mental Health Care
- Office for Civil Rights ("OCR")
- Qui Tam
- Stark Laws
- Urinalysis
- Accountable Care Organizations (“ACO”)
- Affordable Care Act
- Alternative Payment Models
- Anti-Kickback Statute
- Centers for Medicare & Medicaid Services (“CMS”)
- Certificate of Need ("CON")
- Charitable Hospitals
- Compliance
- Data Breach
- Department of Health and Human Services (HHS)
- Electronic Protected Health Information (ePHI)
- False Claims Act
- Federally Qualified Health Centers (“FQHCs”)
- Fee for Service
- Health Information Technology for Economic and Clinical Health Act (HITECH Act)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Professional Shortage Area ("HPSA")
- Hospitals
- HPSA
- HRSA
- Kentucky Board of Medical Licensure
- Limited Services Clinics
- Medicaid
- Medical Staff By-Laws
- Medically Underserved Area ("MUA")
- Medicare
- Mid-Level Practitioners
- Office of Inspector General of the United States Department of Health and Human Services (OIG)
- Part D
- Patient Protection and Affordable Care Act (“ACA”)
- Pharmacists
- Physician Assistants
- Rural Health Centers (“RHCs”)
- Rural Health Clinic
- Telehealth
- American Telemedicine Association (“ATA”)
- Criminal Division of the Department of Justice (“DOJ”)
- Health Care Fraud Prevention and Enforcement Action Team (“HEAT”)
- Hydrocodone
- Kentucky Board of Nursing
- Kentucky Pharmacists Association
- Qualified Health Care Centers (“FQHC”)
- Telemedicine
- Agreed Order
- APRNs
- Chain and Organization System (“PECOS”)
- Douglas v. Independent Living Center of Southern California
- Drug Enforcement Agency ("DEA")
- Emergency Rooms
- Hinchy v. Walgreen Co.
- Jimmo v. Sebelius
- Maintenance Standard
- Overpayments
- United States ex. Rel. Kane v. Continuum Health Partners
- Vitas Innovative Hospice Care
- Webinar
- 2014 Medicare Physician Fee Schedule (“PFS”)
- 501(c)(3)
- All-Payer Claims Database ("APCD")
- Appeal
- Chiropractic services
- Chronic Care Management
- Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
- Compliance Officer
- Compounding
- CPR
- Dispenser
- Drug Quality and Security Act (“DQSA”)
- Enrollment
- Essential Health Benefits
- HealthCare.gov
- House Bill 3204
- ICD-9
- Kentucky Senate Bill 7
- Kindred v. Cherolis
- Long-term care communities
- Medicare Part D
- Minors
- National Drug Code ("NDC")
- New England Compounding Center ("NECC")
- Ophthalmological services
- Outsourcing facility
- Physician Compare website
- Ping v. Beverly Enterprises
- Power of Attorney ("POA")
- Prescriber
- Re-validation
- State Health Plan
- Sustainable Growth Rate (“SGR”)
- Texting
- "Plan of Correction"
- Affinity Health Plan
- Arbitration
- Audit
- Cadillac tax
- Centers for Disease Control and Prevention
- Community health needs assessment (“CHNA”)
- Condition of Participation ("CoP")
- Daycare centers
- Decertification
- Denied Claims
- Department of Medicaid Services’ (“DMS”)
- Division of Regulated Child Care
- EHR vendor
- Employer Group Health Plans
- Employer Mandate
- ERISA
- Fair Labor Standards Act (FLSA)
- False Billings
- Federation of State Medical Boards (“FSMB”)
- Food and Drug Administratio
- Form 4720
- Grace Period
- Health Professional Shortage Areas (“HPSA”)
- Health Reform
- Home Health Prospective Payment System
- Home Medical Equipment Providers
- Hospitalists
- Individual mandate
- Inpatient Care
- Intermediate Sanctions Agreement
- Kentucky Health Benefit Exchange
- Kentucky Medical Practice Act
- Kynect
- Licensed practical nurses (LPN)
- Licensure Requirements
- List of Excluded Individuals and Entities
- LLC v. Sutter
- Long-Term Care Providers ("LTC")
- Low-utilization payment adjustment ("LUPA")
- Meaningful use incentives
- Medicare Administrative Coordinators
- Medicare Benefit Policy Manual
- Medicare Shared Saving Program (MSSP)
- Mobile medical applications ("apps")
- Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”)
- National Institutes of Health
- Network provider agreement
- Nonprofit hospitals
- Nonroutine medical supplies conversion factor (“NRS”)
- Nurse practitioners (NP)
- Office of the National Coordinator for Health Information Technology (“ONC”)
- Part A
- Part B
- Payors
- Personal Service Entities
- Physician Payments
- Physician Recruitment
- Physician shortages
- Provider Self Disclosure Protocol
- Qualified Health Plan ("QHP")
- Quality reporting
- Registered nurses (RN)
- Residency Programs
- Self-Disclosure Protocol
- Social Media
- Spousal coverage
- Statement of Deficiency ("SOD")
- Trade Association Group Coverage
- Upcoding
- UPS
- “Superuser”
- Advanced Practice Registered Nurses
- Autism/ASD
- Business Associate Agreements
- Business Associates
- Call Coverage
- Compliance Programs
- Doe v. Guthrie Clinic
- Essential Health Benefits (“EHBs”)
- Genetic Information Nondiscrimination Act ("GINA")
- Group Purchasing Organizations ("GPO")
- House Bill 104
- Kentucky House Bill 159
- Kentucky House Bill 217
- Kentucky Primary Care Centers (“PCCs”)
- Managed Care Organizations (“MCOs”)
- Medicare Audit Improvement Act of 2012
- Patient Autonomy
- Patient Privacy
- Personal Health Information
- Recovery Audit Contractors (“RAC”)
- Senate Bill 39
- Senate Finance Committee Report
- Small Business Health Options Program (“SHOP”)
- State Medicaid Expansion
- Abuse and Waste
- Center for Disease Control
- Consumer Operated and Oriented Plan programs (“CO-OPS”)
- Critical Access Hospitals (“CAHs”)
- Free Conference Committee Report
- Healthcare Information and Management Systems Society (HIMSS)
- House Bill 1
- House Bill 4
- Kentucky Cabinet for Health and Family Services
- Kentucky Health Care Co-Op
- Kentucky Health Cooperative (“KYHC”)
- Kentucky “Pill Mill Bill”
- Occupational Safety and Health Administration (“OSHA”)
- Pain Management Facilities
- Sunshine Act
- Employee Agreement
- Health Care Fraud and Abuse Control Program
- Health Insurance
- Healthcare Regulation
- Health Care Law
McBrayer Blogs
HIPAA Rules and Procedures in the Event of a Data Breach, Part Two
My last post focused on the discovery and investigation of a data security breach to determine if breach notification is needed. Today’s post now turns to the requirements of breach notification triggered by a data security breach.
Notification to Individual Patients
When a breach is discovered and a covered entity (CE) determines that unsecured ePHI has been compromised, that entity must notify all individuals whose information was affected by the breach without unreasonable delay, defined as within 60 calendar days from discovery of the breach.[1] Discovery is legally defined as having occurred on the first day the breach is known or should have known.[2] This definition means that the clock begins running from the moment the breach is or should have been discovered. This requirement means that an investigation must be conducted quickly and efficiently after discovery of the incident, so that determination of the necessity of notification occurs quickly and breach notification, if necessary, is timely.
If breach notification is required, the patient notice of the security breach should contain the following:
- a description of what happened (the breach incident),
- the types of unsecured ePHI involved,
- steps patients should take to protect themselves,
- a description of the actions taken by the CE to investigate and mitigate the effects of the breach,
- the actions taking to prevent future breaches, and
- information about how to contact the CE about the breach.
In addition, the breach notification should be written in plain language[3] that the average patient can understand.
This notice must then be mailed via first-class mail to the last-known address of the individual or by email, if the individual has agreed to receive notice in that manner. However, a substitute notice must be used, where the CE has insufficient or out-of-date contact information for more than 10 of the individuals. In this case, the CE must post a conspicuous breach notification on its website for 90 days or in the local media in the area affected by the breach as well as provide a toll-free number for phone calls.
Notification of the HHS Secretary
A CE must also inform the Secretary of HHS, when a breach occurs that triggers notification provisions. If the breach affects less than 500 people, the CE can log the breach and present it with all other breaches in an annual report within 60 days of the end of the calendar year.
If more than 500 people are affected, the notice must be contemporaneous with the other required notices. In other words, a large data breach requires more immediate reporting to HHS.
Notification to the Media
When more than 500 residents of a state or jurisdiction are affected by the breach, the covered entity must notify all “prominent media outlets serving the State or jurisdiction.”[4] This option is not pleasant and can seriously damage a CE’s reputation. As a result, CEs need to be vigilant in monitoring and strengthening its security systems to prevent large data breaches. The bad press and financial consequences that a media publication may bring is incentive to review compliance with the Security and Privacy rules and take further steps to encrypt all ePHI.
Duties of Business Associations
Business Associates (BA) have similar timelines in terms of notification, but a BA is only required to notify the CE. HHS commentary to the regulations states, however, that if the BA is acting as an agent of a covered entity, the BA’s discovery of a breach will then be imputed to the CE itself, starting the notification countdown, not when the CE receives notice of the breach, but when the BA discovers it. This is a particularly troubling result, as a BA that delays in reporting a breach to a CE could significantly shorten the 60 days window for a CE to notify affected individuals.
CEs and BAs should continually monitor and reevaluate their security systems that store, transmit, use PHI, in light of modern security standards and data breaches. As has been shown by the data breaches at Anthem, Target and Sony, no entity can be too careful in the protection of client data.
For more information on compliance issues with HIPAA Security and Privacy Rules or how to mitigate the damage done in an ePHI data breach, contact the attorneys at McBrayer.
Services may be performed by others.
This article does not constitute legal advice.
[1] 45 CFR 164.404(b)
[2] 45 CFR 164.404(a)(2)
[3] Ibid.
[4] 45 CFR §164.406(a)