Federal Regulations And Today’s Business!

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Federal Regulations And Today’s Business!
Are you in trouble NOW?

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Federal Regulations And Today’s Business!

  1. 1. Federal Regulations And Today’s Business! Are you in trouble NOW? Presented By Tim McGuinness, Ph.D. Certified Senior Regulatory Compliance Specialist & Examiner Sponsored By The Pascall Company
  2. 2. Visit www. R egulatory C ompliance. us for more info Welcome To Regulatory Compliance 101
  3. 3. Yes! You probably ARE in trouble NOW!
  4. 4. The Age of Privacy & Security <ul><li>Today, we live in a climate of ever increasing risks to our private information! From Identity Thieves, to Hackers, to Telemarketers! The list goes on and on! </li></ul><ul><li>We are ALL Victims! </li></ul>
  5. 5. Consumers Demand Action! <ul><li>Responding to ever increasing threats to PRIVACY & RECORD SECURITY, consumers demand action from Government! </li></ul><ul><li>Government responds with regulations! </li></ul><ul><ul><li>GLBA – HIPAA – FERPA – CRA – SOX PPRA – COPPA – Privacy Act – GCP 21cfr11 – Homeland Security! – and more! </li></ul></ul>
  6. 6. Why Worry? We Do A Better Job!? <ul><li>America already does a better job at protecting privacy than other countries right? </li></ul><ul><ul><li>WRONG! We have a National Crisis! </li></ul></ul><ul><ul><li>The U.S. is significantly behind! </li></ul></ul><ul><ul><li>This Privacy Gap has already interfered in international business! </li></ul></ul><ul><ul><li>But we’re catching up! </li></ul></ul>
  7. 7. The Fed Has Had It! <ul><li>Significant Regulations now exist! </li></ul><ul><ul><li>Gramm-Leach Bliley - GLBA </li></ul></ul><ul><ul><li>HIPAA </li></ul></ul><ul><ul><li>COPPA </li></ul></ul><ul><ul><li>Sarbanes Oxley </li></ul></ul><ul><ul><li>Over 100 new bills working their way through congress! </li></ul></ul>
  8. 8. Major Regulations <ul><li>GLBA – Consumer Financial Information Privacy & Security </li></ul><ul><li>HIPAA – Health Information Privacy & Security </li></ul><ul><li>COPPA – Children’s Information </li></ul><ul><li>SOX – Corporate Data Integrity </li></ul><ul><li>State Laws too! </li></ul><ul><li>And Many Many More – Now & Coming! </li></ul>
  9. 9. Financial Privacy Gramm-Leach Bliley Act GLBA
  10. 10. GLBA <ul><li>Financial Information Privacy & Security </li></ul><ul><li>Privacy & Consumer Rights </li></ul><ul><li>Safeguarding Financial Records </li></ul><ul><li>Best Practice Information Security </li></ul>
  11. 11. GLBA – Who Is Covered? <ul><li>Banks </li></ul><ul><li>Insurance Companies </li></ul><ul><li>Mortgage & Loan </li></ul><ul><li>Securities & Brokerage </li></ul><ul><li>And… </li></ul>
  12. 12. GLBA – Who Is Covered <ul><li>Other “Financial Institutions” </li></ul><ul><li>What is a Financial Institution? </li></ul><ul><ul><li>A Business or Entity that engages in “Financial Activities” </li></ul></ul><ul><ul><li>Can be Private or Public Sector </li></ul></ul>
  13. 13. GLBA – Who Is Covered <ul><li>“Financial Activities” what are they? </li></ul><ul><li>(A) Lending, exchanging, transferring, investing for others, or safeguarding money or securities. </li></ul>
  14. 14. GLBA – Who Is Covered <ul><li>Examples: </li></ul><ul><ul><li>Auto Dealers </li></ul></ul><ul><ul><li>Check Cashing </li></ul></ul><ul><ul><li>Pawn Brokers </li></ul></ul><ul><ul><li>Leasing & Rentals </li></ul></ul><ul><ul><li>Title & Escrow </li></ul></ul><ul><ul><li>Retirement Management </li></ul></ul><ul><ul><li>Medical Savings Accounts </li></ul></ul><ul><li>And On And On And On! </li></ul>
  15. 15. GLBA Privacy Rule <ul><li>Deadline July 2001 </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>Full Assessments – Due Diligence </li></ul></ul><ul><ul><li>Full Workforce Training </li></ul></ul><ul><ul><li>Consumer Notices </li></ul></ul><ul><ul><li>Policies & Procedures </li></ul></ul><ul><ul><li>Safeguards </li></ul></ul><ul><ul><li>Organizational Changes </li></ul></ul><ul><ul><li>Business Relationship Changes </li></ul></ul>
  16. 16. GLBA Safeguards (Security) Rule <ul><li>Deadline May 2003 </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>Full Assessments – Due Diligence </li></ul></ul><ul><ul><li>Full Workforce Training </li></ul></ul><ul><ul><li>Policies & Procedures </li></ul></ul><ul><ul><li>Best Practice Security </li></ul></ul><ul><ul><li>Business Continuity Planning & Implementation </li></ul></ul><ul><ul><li>Organizational Changes </li></ul></ul><ul><ul><li>Business Relationship Changes </li></ul></ul>
  17. 17. GLBA Non-Compliance <ul><li>Enforced By U.S. SEC, Federal Reserve, FTC, and other Federal Agencies </li></ul><ul><ul><li>Penalties up to $100,000 per incident </li></ul></ul><ul><ul><li>Up to 10 years in Jail </li></ul></ul><ul><li>State Attorney Generals </li></ul><ul><ul><li>Civil, and Criminal </li></ul></ul><ul><li>Civil Litigation – Negligence & Fraud </li></ul><ul><ul><li>Privacy is the required Standard of Care </li></ul></ul><ul><ul><li>Beach of Privacy May Be Civil Fraud </li></ul></ul><ul><ul><li>Consumer Agreement Termination </li></ul></ul>
  18. 18. GLBA Myths <ul><li>Even If You Never Heard Of It – Compliance Is Required </li></ul><ul><li>GLBA compliance is not just about a Privacy Notice and policies and procedures </li></ul><ul><li>GLBA compliance is more than a binder in the office </li></ul><ul><li>GLBA compliance can not be done by your attorney alone </li></ul><ul><li>GLBA compliance is unique to Your Business </li></ul><ul><li>GLBA compliance requires specialized skills & knowledge </li></ul>
  19. 19. GLBA Risk <ul><li>A single significant negligent breach will close a business forever! </li></ul><ul><li>Liability insurance does NOT cover GLBA violations! </li></ul><ul><li>Both the organization and its owners and board members are liable! </li></ul><ul><li>Compliance can be a full time task! </li></ul>
  20. 20. GLBA Reality <ul><li>90% of GLBA Covered Entities ARE NOT Compliant </li></ul><ul><li>Almost All Local Governments Are Not Compliant </li></ul><ul><li>Federal Enforcement Is Very Strong and There Is Case Law </li></ul><ul><li>Instant Complaints Online </li></ul><ul><li>Consumers Have Real Power! </li></ul>
  21. 21. Health Privacy Health Information Portability & Accountability Act - HIPAA
  22. 22. HIPAA <ul><li>Health Information Privacy & Security </li></ul><ul><li>Privacy & Consumer Rights </li></ul><ul><li>Safeguarding Patient Records </li></ul><ul><li>Best Practice Information Security </li></ul>
  23. 23. HIPAA – Who Is Covered? <ul><li>Healthcare Providers </li></ul><ul><li>Health Insurers – Payers </li></ul><ul><li>Health Information Clearing Houses </li></ul><ul><li>Business Associates </li></ul><ul><li>Who Transmit Health Information Electronically </li></ul><ul><li>Every Healthcare Entity Under Standards Of Care </li></ul>
  24. 24. HIPAA Privacy Rule <ul><li>Deadline April 2003 </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>Full Assessments – Due Diligence </li></ul></ul><ul><ul><li>Full Workforce Training </li></ul></ul><ul><ul><li>Patient Notices </li></ul></ul><ul><ul><li>Policies & Procedures </li></ul></ul><ul><ul><li>Safeguards </li></ul></ul><ul><ul><li>Organizational Changes </li></ul></ul><ul><ul><li>Business Relationship Changes </li></ul></ul>
  25. 25. HIPAA Security Rule <ul><li>Formal Deadline April 2005 </li></ul><ul><li>Actual Requirement Deadline April 2003 </li></ul><ul><li>Requirements: </li></ul><ul><ul><li>Full Assessments – Due Diligence </li></ul></ul><ul><ul><li>Full Workforce Training </li></ul></ul><ul><ul><li>Policies & Procedures </li></ul></ul><ul><ul><li>Best Practice Security </li></ul></ul><ul><ul><li>Business Continuity Planning & Implementation </li></ul></ul><ul><ul><li>Organizational Changes </li></ul></ul><ul><ul><li>Business Relationship Changes </li></ul></ul>
  26. 26. HIPAA Non-Compliance <ul><li>Enforced By U.S. Dept Health & Human Services </li></ul><ul><ul><li>Penalties up to $250,000 per incident </li></ul></ul><ul><ul><li>Up to 10 years in Jail </li></ul></ul><ul><li>State Attorney Generals </li></ul><ul><ul><li>Civil, Criminal Action or Loss of License </li></ul></ul><ul><li>Civil Litigation – Privacy Malpractice </li></ul><ul><ul><li>Privacy is the required Standard of Care </li></ul></ul><ul><ul><li>Beach of Privacy is Medical Malpractice </li></ul></ul>
  27. 27. HIPAA Myths <ul><li>HIPAA compliance is not just about policies and procedures </li></ul><ul><li>HIPAA compliance is more than a binder in the office </li></ul><ul><li>HIPAA compliance is more than a $300 kit! </li></ul><ul><li>HIPAA compliance is LOCAL! </li></ul><ul><li>HIPAA compliance requires specialized skills & knowledge </li></ul>
  28. 28. HIPAA Risk <ul><li>A single significant negligent breach will close a practice forever! </li></ul><ul><li>Liability insurance does NOT cover HIPAA violations! </li></ul><ul><li>Both the individual AND the organization are liable! </li></ul><ul><li>Compliance is a full time task! </li></ul>
  29. 29. HIPAA Reality <ul><li>50% of Health Care Entities ARE NOT Compliant </li></ul><ul><li>Most Local Governments Are Not Compliant </li></ul><ul><li>Federal Enforcement Is Still Weak </li></ul><ul><li>Civil Litigation Remains Greatest Risk </li></ul>
  30. 30. So Now What? What You Need To Do!
  31. 31. What Do You Need To Do? <ul><li>Take Compliance Seriously! </li></ul><ul><li>Move Rapidly! </li></ul><ul><li>Know What Regulations Affect You! </li></ul><ul><li>Know How It Affects You! </li></ul><ul><li>Get Professional Help! </li></ul><ul><li>Commit, Plan, Implement! </li></ul><ul><li>Manage, and Audit! </li></ul>
  32. 32. The Compliance Cycle Assess & Audit Mitigate & Implement Manage & Maintain Train & Educate
  33. 33. What Do You Need To Do? <ul><li>Accept It – Regulations Are Here Now! </li></ul><ul><li>Compliance Is Good For Your Customers! </li></ul><ul><li>There Are Real Threats! </li></ul><ul><ul><li>From Within & Without! </li></ul></ul><ul><li>You Will Need Help! </li></ul><ul><li>It Takes BOTH An Attorney & An Implementation Specialist! </li></ul>
  34. 34. First Steps! <ul><li>Contract A Regulatory Compliance Specialist to help you understand your Compliance Responsibilities! </li></ul><ul><li>Remember, your Attorney is Probably Not a Regulatory Law Attorney! </li></ul><ul><li>Regulations Require Very Specialized Knowledge! </li></ul><ul><li>Regulations Change! </li></ul>
  35. 35. First Steps! <ul><li>Start Right Now! </li></ul><ul><li>Assess Your Real Compliance Gaps </li></ul><ul><li>Implement Compliant Policies & Procedures, and Business Processes </li></ul><ul><li>Implement Best Practice Security </li></ul><ul><li>Train Your Workforce In Privacy & Security, AND Your Policies & Procedures </li></ul>
  36. 36. First Steps! <ul><li>Choose, Appoint, Hire A Professional Compliance Officer </li></ul><ul><li>Accommodate Patient/Customer Rights </li></ul><ul><li>Manage Compliance / Manage Change! </li></ul><ul><li>Adopt Business Continuity Requirements - Plan For The Worst </li></ul><ul><li>Audit Audit Audit and Audit Again! </li></ul>
  37. 37. Do You Need Help Now? <ul><li>Contact Us At: </li></ul><ul><li>Tim McGuinness, Ph.D. [email_address] 727-787-9801 www.RegulatoryCompliance.us </li></ul>
  38. 38. Visit www.RegulatoryCompliance.us Don’t Wait! Get Help NOW! It’s The Law!

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