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Learn about HIPAA regulations, compliance requirements, protected health information, penalties, and the importance of maintaining confidentiality in healthcare settings. Discover essential rules, guidelines, and steps for compliance.
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HIPAA CONFIDENTIALITY Paul A. Stewart, Esq. Foley & Lardner One Maritime Plaza, 6th Floor San Francisco, CA pastewart@foleylaw.com
What’s to Simplify? • Health Claims Encounter Information • Attachments to Health Claims • Health Plan Enrollment/Disenrollment • Eligibility Verification • Claims Payments/Remittance Advice • Payment of Premiums • First Report of Injury • Referral Certification/Authorization • Claim Status • Coordination of Benefits
Who Must Comply? • A “Health Care Provider” - Furnishes, Bills or Gets Paid for Health Care Services or Supplies • A “Health Plan” - Provides or Pays for Medical Care • A “Health Care Clearinghouse” - processes non-standard into standard data elements • “Business Partners” - Agents of Covered Entities
To What Do Regulations Apply? • “Health Information” (security regulations) • Created by providers, health plans, public health authorities, employers, life insurers, schools or universities • Relates to the physical/mental condition, provision of health care, payment
To What Do Regulations Apply? (cont’d) • “Protected Health Information” (“PHI”) (confidentiality regulations) • health information • identifies the individual or • could reasonably be used to identify the individual
When To Comply? • Whenever health information is electronically transmitted or maintained (security regulations) • Whenever protected health information is electronically transmitted or maintained in connection with a standard transaction (confidentiality regulations) • Obligations apply to information, not documents
Why Comply? • Civil Monetary Penalties: up to $100 Per Violation/Per Person, with $25,000 Annual Limit Per Each Standard Violated • Criminal Penalties for “Knowing Misuse”: $50,000–$250,000; Prison 1–10 years • Greatest Penalties Reserved for Intent to Sell/Transfer/Use for Commercial Advantage, Personal Gain or Malicious Harm
What are the confidentiality Rules? • Disclosure/Use prohibited except as permitted by the regulation • Permitted Disclosures: • As authorized by the individual • For health care treatment, payment, operations (except research and psychotherapy notes) • In connection with national policy activities
What are the Rules? (cont’d) • Required Disclosures • Request by the individual • Investigation of compliance by government • Circumstances Requiring Individual Authorization • Marketing; sale, rental, barter; eligibility; fundraising; employers; research unrelated to treatment; psychotherapy notes • Minimum Necessary
What are the Rules? (cont’d) • Patient Rights • To Receive Adequate Notice of Information Practices • To Inspect and Copy PHI • To Request Amendment/Correction of PHI • To Request Restriction on Uses/Disclosure of PHI • To Receive Accounting of Uses/Disclosures
What Do I Have To Do? • Designate a Privacy Official • Contact person/office • Assess whether HIPAA preempts state law • Assess current policies and procedures • Develop comprehensive policies and procedures • Draft contracts - Business partner/Chain of trust agreements
Preemption • Assess whether HIPAA preempts state law • Federal standard, requirement or implementation specification contrary to state law • Exceptions • State law is necessary for certain purposes • State law is more stringent • State law relates to audits, licensure, certification, reporting of child abuse, births, deaths, injuries, public health activities
Policies and Procedures • Assess current policies and procedures • What does your organization do to ensure PHI is not improperly disclosed? • How do you monitor compliance with your current policies and procedures? • What are the consequences in your organization if PHI is disclosed in violation of current legal requirements/p&p’s? • Are your policies and procedures written?
Policies and Procedures (cont’d) • Develop comprehensive policies and procedures related to: • Determining when disclosures are permitted/required • Conditions applicable to certain permitted disclosures • Minimum necessary standard • Authorizations
Policies and Procedures (cont’d) • De-identifying PHI • Business partners • Deceased individuals • Right to requests for restrictions • Right to notice of information practices • Right to access
Policies and Procedures (cont’d) • Right to accounting of disclosures • Right to amendments and corrections • Verification of identity/authority of requester • Training • Sanctions • Complaints • Changes in policies or procedures
Further Documentation • Must create documents related to the following and retain such documents for six years: • Requested restrictions • Contracts with business partners • Authorization forms • Notifications of information practices
Further Documentation (cont’d) • Statements regarding access/denial to PHI • All accountings provided • Denials of amendment/correction requests • Employee certifications • Complaints
Business Partner Contracts Examples: Lawyers, auditors, consultants, TPA’s, DP firms • Disclosures only as permitted/required • No disclosures if disclosure by covered entity would violate regulation • Safeguards established to prevent improper uses/disclosures • Improper uses/disclosures reported • Consistent subcontracts • Right of access provided
Business Partner Contracts (cont’d) • Access by Secretary of DHHS to books/records pertaining to uses/disclosures • PHI returned/destroyed upon termination of contract • Amendments/corrections incorporated • Third party beneficiaries/Liability to Patients for breach • Termination upon improper use/disclosure • Material breach may be noncompliance • Need for audit trail