HIPAA, ARRA & HITECH Health Insurance Portability & Accountability Act of 1996 Not HIPPA (Health Insurance Portability Prevention Act) American Recovery & Reinvestment Act Health Information Technology for Economic and Clinical Health
HITECH Requirements Expands the definitions of “business associates.” Mandates that HIPAA security standards that apply to health plans and health care providers will also apply directly to business associates. Establishes new security breach notice requirements. Entitles individuals to electronic copies of health information. Calls for regulations regarding the sale of electronic health records and protected health information by mid-August, 2010.
Business Associates “Business associates” are persons and organizations (typically subcontractors) that perform activities involving the use or disclosure of individually identifiable health information, such as claims processing, data analysis, quality assurance, billing, and benefit management, as well as those who provide legal, accounting, or administrative functions. 45 CFR §160.103. The HITECH Act adds as “business associates” organizations that transmit protected health information and require access on a routine basis to such information. See 42 USC §17938.
Business Associates Subject to the administrative, physical, and technical security requirements of HIPAA, must implement appropriate policies and procedures, and must document their security activities. Penalties for violating these HIPAA procedures will apply to business associates, just as they now do to health plans and health care providers. 42 USC §17931.
Breach Notification a health plan or health care provider that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information and discovers a breach of the information to notify each individual whose health information has been, or is reasonably believed to have been, accessed, acquired, or disclosed as a result of the breach. 42 USC §17932(a). Business associates will also be required to give notice of such a data breach to the health plan or health care provider, and will need to identify each individual whose unsecured protected health information was illegally accessed, acquired, or disclosed. 42 USC §17932(b). The health plan, health care provider, or business associate will be required to give notice of the breach without unreasonable delay, and no later than 60 calendar days after its discovery. 42 USC §17932(d). Notice must be provided by first-class mail to individuals at their last known address, or, if specified by the individual, via e-mail. 42 USC §17932(e)(1).
Individual Patient Rights Individuals are entitled to copies of their health information in electronic format from any health plan or health care provider that uses or maintains electronic health records. An individual will be able to direct the health plan or health care provider to transmit the copy directly to anyone he or she designates. Fees for providing this service must not be greater than the entity’s labor costs. 42 USC 17935(e).
Authorization The HITECH Act will prohibit a health plan, health care provider, or business associate from receiving payment for an individual’s protected health information without authorization from the individual. 42 USC §17935(d).
New Penalties Increased Civil Penalties ARRA creates the following "tiers" of penalties: A violation without knowledge of the violation - $100 per violation, with an annual maximum amount of $25,000 in penalties. A violation that is due to reasonable cause - $1,000 per violation, with an annual maximum amount of $100,000 in penalties. A violation that is due to willful neglect - $10,000 per violation, with an annual maximum amount of $1,500,000 in penalties.
New Enforcement State Attorneys General now have the authority to file suit in federal court against any person or entity that is accused of violating HIPAA in a manner that the Attorney General has reason to believe adversely affected any resident of that Attorney General's respective state.
Red Flags – Who Must Comply? The Red Flags Rules apply to “financial institutions” and “creditors” with “covered accounts.”
Red Flags – Financial Institutions State or national bank, a state or federal savings and loan association, a mutual savings bank, a state or federal credit union, or any other entity that holds a “transaction account” belonging to a consumer. Most of these institutions are regulated by the Federal bank regulatory agencies and the NCUA. Financial institutions under the FTC’s jurisdiction include state-chartered credit unions and certain other entities that hold consumer transaction accounts.
Red Flags – Transaction Account A transaction account is a deposit or other account from which the owner makes payments or transfers. Transaction accounts include checking accounts, negotiable order of withdrawal accounts, savings deposits subject to automatic transfers, and share draft accounts.
Red Flags - Creditor Any entity that regularly extends, renews, or continues credit; any entity that regularly arranges for the extension, renewal, or continuation of credit; or any assignee of an original creditor who is involved in the decision to extend, renew, or continue credit. Accepting credit cards as a form of payment does not in and of itself make an entity a creditor. Creditors include finance companies, automobile dealers, mortgage brokers, utility companies, and telecommunications companies. Where non-profit and government entities defer payment for goods or services, they, too, are to be considered creditors.
Red Flags – Covered Account An account used mostly for personal, family, or household purposes, and that involves multiple payments or transactions. Covered accounts include credit card accounts, mortgage loans, automobile loans, margin accounts, cell phone accounts, utility accounts, checking accounts, and savings accounts. A covered account is also an account for which there is a foreseeable risk of identity theft – for example, small business or sole proprietorship accounts
Red Flags – Exempt? Only Lawyers FTC has filed a Notice of Appeal Judge Walton is reported to have questioned whether the term could be interpreted so broadly as to render a plumber who bills a customer after performing his work a "creditor" within the meaning of the Rule. CPA’s have filed a lawsuit
Red Flags - Requirements Develop a written program that identifies and detects the relevant warning signs – or “red flags” – of identity theft. These may include, for example, unusual account activity, fraud alerts on a consumer report, or attempted use of suspicious account application documents. The program must also describe appropriate responses that would prevent and mitigate the crime and detail a plan to update the program. The program must be managed by the Board of Directors or senior employees of the financial institution or creditor, include appropriate staff training, and provide for oversight of any service providers.
Red Flags – Requirements – suggested “Starting Points” alerts, notifications, or warnings from a consumer reporting agency; suspicious documents; suspicious personally identifying information, such as a suspicious address; unusual use of – or suspicious activity relating to – a covered account; and notices from customers, victims of identity theft, law enforcement authorities, or other businesses about possible identity theft in connection with covered accounts.
Scope of Rules Covers ALL PERSONS that own or license personal information about a Massachusetts resident Need not have operations in Massachusetts Financial institutions, health care and other regulated entities not exempt
Scope of Rules “Personal information” Resident’s first and last name or first initial and last name in combination with SSN Driver’s license or State ID, or Financial account number or credit/debit card that would permit access to a financial account
Three Requirements 1.Develop, implement, maintain and maintain a comprehensive, written information security program that meets very specific requirements (cWISP) 2.Heightened information security meeting specific computer information security requirements 3.Vendor Compliance (Phase-in)
Evaluating Compliance(not Evaluating Applicability) Appropriate Size of business Scope of business Type of business Resources available Amount of data stored Need for security and confidentiality Consumer and employee information
Evaluating Compliance(not Evaluating Applicability) “The safeguards contained in such program must be consistent with the safeguards for protection of personal information and information of a similar character set forth in any state or federal regulations by which the person who owns or licenses such information may be regulated.”
Enforcement Litigation and enforcement by the Massachusetts Attorney General Massachusetts law requires notice to Attorney General of any breach, in addition to affected consumers Attorney General likely to investigate based on breach reports No explicit private right of action or penalties
Information SecurityProgram “[D]evelop, implement, and maintain a comprehensive information security program that is written in one or more readily accessible parts and contains administrative, technical, and physical safeguards”
Comprehensive Information Security Program201 CMR 17.03 (2)(a) through (j) a. Designate b. Identify c. Develop d. Impose e. Prevent Oversee Restrict Monitor Review Document
Comprehensive Information Security Program (a) Designate an employee to maintain the WISP. (b) Identify and assess reasonably foreseeable risks (Internal and external). (c) Develop security policies for keeping, accessing and transporting records. (d) Impose disciplinary measures for violations of the program. (e) Prevent access by terminated employees. (f) Oversee service providers and contractually ensure compliance. (g) Restrict physical access to records. (h) Monitor security practices to ensure effectiveness and make changes if warranted. (i) Review the program at least annually. (j) Document responsive actions to breaches.
Comprehensive Information Security Program Third Party Compliance 1. Taking reasonable steps to select and retain third-party service providers that are capable of maintaining appropriate security measures to protect such personal information consistent with these regulations and any applicable federal regulations; and 2. Requiring such third-party service providers by contract to implement and maintain such appropriate security measures for personal information
Comprehensive Information Security Program Third Party Compliance Contracts entered “no later than” March 1, 2010: Two – year phase-in. Contracts entered into “later than” March 1, 2010: Immediate compliance.
Comprehensive Information Security Program “INDUSTRY STANDARDS”
Breach Reporting Breach of security – “the unauthorized acquisition or unauthorized use of unencrypted data or, encrypted electronic data and the confidential process or key that is capable of compromising the security, confidentiality, or integrity of personal information, maintained by a person or agency that creates a substantial risk of identity theft or fraud against a resident of the commonwealth. A good faith but unauthorized acquisition of personal information by a person or agency, or employee or agent thereof, for the lawful purposes of such person or agency, is not a breach of security unless the personal information is used in an unauthorized manner or subject to further unauthorized disclosure.”
Breach Reporting Possessor must give notice of Breach of Security Unauthorized Use or Acquisition To Owner/Licensor of Information Owner/Licensor must give notice of Breach of Security Unauthorized Use or Acquisition To – Attorney General Office of Consumer Affairs Resident
Breach Reporting “The notice to the Attorney General and the Director of Consumer Affairs and Business Regulation shall include, but not be limited to: the nature of the breach of security or the unauthorized acquisition or use; the number of Massachusetts residents affected by such incident at the time of notification; and any steps the person or agency has taken or plans to take relating to the incident.”
Sample Breach Notification Letter http://www.mass.gov/Cago/docs/Consumer/93h_sampleletter_ago.pdf
Use authentication protocols Secure access controls Encryption of transmittable records Mentoring systems
User Authentication Protocols Control of user IDs Secure password selection Secure or encrypted password files User accounts blocked for unusual logon attempts Examples: Passwords should be at least 9 characters, alpha numeric with special characters After 3 attempts to login users are blocked access
Secure Access Control Measures Permit “access” on a need to know basis Password protect account and login to determine level of access Example: Network Access Control Software/Hardware Consentry Sophos Audit control who is accessing what and when?
Encryption of Transmitted Records Encryption of personal information accessed over a public network Tunneling options (VPN) Faxes, VOIP, phone calls Encryption of PI on wireless Bluetooth, WEP, Wifi Encryption definition if very broad Examples: PGP and Utimaco are encryption technologies
Monitoring of Systems Require systems to detect unauthorized use of, access to personal information Some existing user account based on systems will already comply Examples: Again, Network Access Control Audit controls
Laptop and Mobile Device Encryption Encryption of PI stored on laptops Applies regardless of laptop location Encryption of PI stored on “mobile” devices Does incoming email become a problem? This applies only if you have data in motion of personal information. Email is clear text. So anyone can read any ones email on the internet.
Security Patches and Firewalls “Reasonably up-to-date firewall protection and operating systems patches” for Internet connected computers Date on operating systems All organizations should have a firewall in place (not a router a firewall) Can hire an organization to update and manage the security infrastructure: Firewall Anti-virus Patches…
Systems Security Agent Software Malware is what is infecting most enviroments. HTTP and HTTPS traffic. Your users are your worst enemy Products to look at for Malware TrendMicro Websense Webwasher Anti-malware technology required Are certain products better? What about MACs or Linux? Set to receive auto-updates
Employee Education and IT Security Training Proper training on all IT security policies User awareness Importance of PI security Proper use of the computer Everyone is involved Your employees are your weakest link to any IT security program. They need to know the rules. Suggestions: Stand up training News Letters Programs Online training
The Approach Inventory type of personal information is being kept Assess risk Plan information security strategy Data Security, Confidentially, Integrity IT infrastructure and information change processes Implement, plan and policies Technology deployment Policy implementation User awareness Continual review Security is all about vigilance… Compliance is knowing what you need to protect and building a fortress around it and testing it on a frequent basis!