RULES OF THE ROAD: SUCCESSFULLY NAVIGATING THE GUIDEPOSTS ON THE SOCIAL MEDIA HIGHWAY

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RULES OF THE ROAD SUCCESSFULLY NAVIGATING THE
GUIDEPOSTS ON THE SOCIAL MEDIA HIGHWAY

• KENNETH N. RASHBAUM, ESQ.
• RASHBAUM ASSOCIATES, LLC

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AGENDA NAVIGATING ROAD OBSTACLES WITH SOCIAL
MEDIA GPS

• REGULATORY NETWORK FDA, FTC, CMS (HIPAA)
• PRIVACY AND SECURITY LAWS (DOMESTIC AND GLOBAL)
• OVERCOMING FEAR AND MISUNDERSTANDING
• SOCIAL MEDIA GPS DIALOGUE WITH COMPLIANCE AND
  LEGAL INTERDISCIPLINARY DRAFTING OF PRACTICABLE
  POLICIES AND PROCEDURES TRAINING AND COMPLIANCE
  MONITORING

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SIGNS AND DIVIDING LINES

• FDA PART 15 HEARINGS AND ANTICIPATE D
  GUIDANCE(WILL IT EVER COME?)
• FTC GUIDELINES
• U.S. PRIVACY LAWS HIPAA, FEDERAL SUBSTANCE ABUSE
  PROTECTIONS, STATE PRIVACY LAWS
• PRIVACY LAWS OUTSIDE THE U.S. PERSONAL
  INFORMATION EXPORT RESTRICTIONS (EX GOOGLE
  CONVICTION IN ITALY) AND PROHIBITIONS ON EMPLOYEE
  TECHNOLOGY USE MONITORING

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HAZARD SIGNS COMPLIANCE, RISK AND LEGAL

• FEAR AND MISUNDERSTANDING
• SOCIAL MEDIA IS EVERYWHERE. THEREFORE, RISK IS
  EVERYWHERE!!!
• WE CANNOT CONTROL IT, SO IT MUST BE STOPPED!
• BUSINESS UNITS MAY HAVE SOMETHING TO SAY AOBUT
  THAT, THOUGH
• HOW BRIDGE THE GAP TO CREATE ALLIES?

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OLD PARADIGM FEAR

• BEWARE OF HEALTH BOOKS. YOU MAY DIE OF A
  MISPRINT. MARK TWAIN
• THE FUTURE IS JUST ONE DAMN THING AFTER
  ANOTHER. WALTER OMALLEY
• WE ARE DIFFERENT, SO HIGHLY REGULATED WE JUST
  CANT ENGAGE IN SOCIAL MEDIA. ANONYMOUS
  PHARMACEUTICAL EXECUTIVE

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NEW PARADIGM RESPONSIBLY EMBRACING THE MEDIUM

• PRECISELY BECAUSE OF THE SPECIAL DIFFERENCE
  (AND) THE (INDUSTRYS) RESPONSIBILITY OF
  ADVANCING THE PUBLIC HEALTH AGENDA, THESE
  COMPANIES MUST ENGAGE ACTIVELY AND CREATIVELY IN
  SOCIAL MEDIA. PETER J. PITTS, DIRECTOR, GLOBAL
  HEALTH, PORTER NOVELLI

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UNDERSTANDING THROUGH DIALOGUE

• WORKING KNOWLEDGE OF THE REGULATORY AND LEGAL
  FRAMEWORK FACILITATES THE CONVERSATION
• ROAD SIGNS NEED NOT BE ROAD BLOCKS
• DISCUSS HOW TO INCORPORATE GUIDEPOSTS INTO MORE
  EFFECTIVE POLICIES AND PROCEDURES FOR SOCIAL
  MEDIA UTILIZATION

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FDA PART 15 HEARINGS

• FIVE QUESTIONS CONSIDERED
• 1. ACCOUNTABILITY FOR ONLINE COMMUNICATIONS?
• 2. HOW CAN THESE COMPANIES FULFILL REGULATORY
  REQUIREMENTS (FAIR BALANCE, POST-MARKETING
  SUBMISSIONS, SAFETY, ETC.) IN SPACE-LIMITING
  MEDIA?
• 3. WHAT PARAMETERS SHOULD APPLY TO POSTING OF
  CORRECTIVE INFORMATION?

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FDA PART 15 HEARINGS

• 4. WHEN IS THE USE OF LINKS APPROPRIATE (I.E.,
  HOW MANY PEOPLE CLICK ON THE LINKS, WHICH MAY
  CONTAIN HIGHLY PERTINENT INFORMATION?
• EX SAFETY INFORMATION, SIDE EFFECTS. ATTORNEYS
  AND ACCOUNTANTS FACE SIMILAR ISSUES IN THEIR
  DISCLAIMER REQUIREMENTS

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FDA PART 15 HEARINGS

• 5. QUESTIONS ON INTERNET AS A VEHICLE FOR ADVERSE
  EVENT REPORTING
• MONITORING SITES CAN UNEARTH ADVERSE EVENTS,
  TRIGGERING REPORTING OBLIGATIONS. CAN/SHOULD
  COMPANIES REFRAIN FROM MONITORING FOR FEAR OF
  FINDING ADVERSE EVENTS?
• HOW SIGNIFICANT IS THIS ISSUE TO WHAT EXTENT
  WOULD PATIENTS REPORT ON SOCIAL MEDIA SITES?
• IDENTIFIABLE PATIENT AND REPORTER REQUIRED. WHAT
  OF ANONYMOUS OR PSEUDONYM POSTINGS?

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FDA PART 15 HEARINGS MANY PRESENTATIONS, LITTLE
INSIGHT

• AE, SPACE-LIMITING MEDIA, MECHANISMS FOR
  CORRECTION OF INFORMATION DISCUSSED BUT NO REAL
  INDICATION OF WHAT, HOW OR WHEN FDA WILL ISSUE
  GUIDANCE
• FDA LIMITATIONS STATUTORY AUTHORITY LIMITED
  PURSUANT TO FOOD, DRUG AND COSMETIC ACT (FTC MAY
  HAVE GREATER JURISDICTION) FIRST AMENDMENT ISSUES

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FTC GUIDELINES

• FEDERAL JURISDICTION OVER ADVERTISING
• LIABILITY FOR FALSE STATEMENTS ABOUT PRODUCT
• GUIDELINES REQUIRE DISCLOSURE OF AFFILIATION,
  I.E., EMPLOYMENT OR OTHER RELATIONSHIP WITH
  COMPANY

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FTC GUIDELINES

• TWITTER AND OTHER SPACE-LIMITING MEDIA AND
  DISCLOSURES
• IF YOU CANT MAKE THE DISCLOSURES YOU CANT MAKE
  THE AD. RICHARD CLELAND, ASSOCIATE DIRECTOR,
  ADVERTISING DIVISION
• ARE LINKS SUFFICIENT? WITH WHAT INCIDENCE dO
  PEOPLE CLICK LINKS? (ATTORNEYS AND ACCOUNTANTS
  FACE SIMILAR ISSUES WITH THEIR REQUIRED
  DISCLAIMERS)

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HIPAA AND HITECH

• FEDERAL PRIVACY FLOOR STATES CAN ENACT
  STRICTER PRIVACY PROTECTIONS (I.E.,
  MASSACHUSETTS CALIFORNIA NEW YORK ON HIV/AIDS
  AND REPRODUCTIVE HEALTH)
• INFORMATION IDENTIFIABLE TO A PATIENT BY ONE OR
  MORE OF 18 IDENTIFIERS CANNOT BE DISCLOSED
  WITHOUT PATIENT CONSENT
• HIPAA PENALTIES AND ENFORCEMENT SIGNIFICANTLY
  INCREASED UNDER HITECH (PART OF ARRA STIMULUS)
• NOT ALL PHARMACEUTICALS ARE COVERED BY HIPAA

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HIPAA AND HITECH

• CONSTRAINTS ON MARKETING ACTIVITIES IN HIPAA
  ENHANCED UNDER HITECH NO REMUNERATION FOR PHI
  WITHOUT EXECUTED AUTHORIZATION
• CONSIDER PRIVACY AWARENESS OF WORK FORCE MEMBERS
  WHO USE SOCIAL MEDIA
• ADDITIONAL REQUIREMENTS PORTABLE MEDIA
  SAFEGUARDS ACCESS CONTROLS TO MEDIA WITH PHI
  ENCRYPTION OF PHI AT REST AND IN TRANSMISSION

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PENDING LEGISLATION BOUCHER(D)-STEARNS (R) BILL

• EXTENSIVE PRIVACY COVERAGE
• PRIVACY NOTICE AND OPPORTUNITY TO OPT-OUT OF
  COLLECTION OR USE OF COVERED INFORMATION
• MUST OBTAIN OPT-IN BEFORE SHARING COVERED
  INFORMATION WITH UNAFFILIATED PARTIES
• PREPARE AND IMPLEMENT PHYSICAL, ADMINISTRATIVE
  AND TECHNICAL SAFEGUARDS ON COVERED INFORMATION
• ENFORCEMENT AUTHORITY GIVEN TO FTC

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PRIVACY MINEFIELD FOR MULTINATIONALS

• EUROPEAN UNION PRIVACY DIRECTIVES AND ENABLING
  LEGISLATION PERSONAL INFORMATION CANNOT BE
  TRANSMITTED BEYOND EEA WITHOUT DATA SUBJECTS
  CONSENT
• PERSONAL INFORMATION IS BROADLY DEFINED
• EASY TO GET CAUGHT IN PRIVACY ENFORCEMENT NET
• RECENT CONVICTION OF GOOGLE FOR YOU TUBE VIDEO
  UPLOADED FROM ITALY

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MULTINATIONAL PRIVACY MINEFIELD

• IN MANY COUNTRIES, SUCH AS GERMANY, EMPLOYEE
  CONSENT IS CONSIDERED INVOLUNTARY
• MOST MONITORING OF EMPLOYEE TECHNOLOGY USE IS A
  CRIMINAL OFFENSE IN CERTAIN EUROPEAN UNION MEMBER
  STATES
• MONITORING SOCIAL MEDIA POLICY COMPLIANCE BECOMES
  VERY DIFFICULT
• SOLUTION EFFECTIVE, PRACTICABLE SOCIAL MEDIA
  POLICIES AND PROCEDURES AND TRAINING

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ACQUIRING SOCIAL MEDIA GPS

• GAP ANALYSIS OF EXISTING POLICIES AND PROCEDURES
• INTERDISCIPLINARY WORK GROUP TO REVISE PROTOCOLS
  OR PREPARE NEW ONES
• FACILITATED INTERNALLY OR BY OUTSIDE COUNSEL OR
  CONSULTANTS
• MAKE THE BUSINESS CASE FOR SOCIAL MEDIA
• BRING IN BUSINESS OWNERS, RISK,
  COMPLIANCE/PRIVACY, LEGAL, IT

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SOCIAL MEDIA GPS POLICIES AND PROCEDURES

• INCLUDE PROCEDURES REQUIRED BY REGULATIONS
• FTC IDENTIFY YOUR AFFILIATION
• HIPAA NO DISCLOSURES OF INFORMATION LEADING TO
  IDENTIFICATION OF PATIENTS PHI SAFEGUARDS
• APPENDICES FOR STATE RULES AND/OR FOREIGN
  PROVISIONS
• ANTICIPATE TRENDS AND REGULATORY CHANGES (SUCH AS
  POTENTIAL FDA GUIDANCE AND HIPAA GUIDANCE
  DOCUMENTS FROM CMS)

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POLICIES AND PROCEDURES

• SHORT, PLAIN ENGLISH AND INCORPORATE GRC
  PRINCIPLES (GOVERNANCE, RISK AND COMPLIANCE)
• MOST POLICIES INCORPORATE PROCEDURES, AND RARELY
  EXCEED FIVE PAGES
• REFER TO CONTINUING OBLIGATION TO COMPLY WITH
  EXISTING INFORMATION POLICIES AND PROCEDURES
  (SUCH AS PROTECTING CONFIDENTIALITY)
• CONSIDER INCLUSION OF STATEMENT OF ETHICS ( I.E.,
  CORRECTION POLICY, ACCURATE AND FACTUAL POSTINGS,
  MAINTAINING COMPANY CREDIBILITY)

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POLICIES AND PROCEDURES

• TECHNOLOGY CHANGING QUICKLY LAW AND REGULATORY
  AGENCIES ARE RUNNING TO CATCH UP
• REVISIT POLICIES OFTEN AND UPDATE AS NEEDED
• PROVIDE FOR FLEXIBILITY IN THE POLICIES CONTENT,
  ACCESS (WHO CAN CONTRIBUTE), MEDIA CHOICES,
  NON-COMPANY MEDIA USAGE, ETC.

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TRAINING

• THREE MODES CLASSROOM, ON-LINE, COMBINATION
• SCALABLE BY JOB TITLE AND FUNCTION
• ALL DISCIPLINES INVOLVED MUST ATTEND
• DOCUMENT the TRAINING NECESSARY IF PROBLEMS
  ARISE LATER, TO SHOW REASONABLE STEPS IN
  COMPLIANCE
• DEPLOY REMINDER POP-UPS PERIODICALLY, AND HOLD
  REMINDER SESSIONS

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COMPLIANCE MONITORING

• REVIEW CORPORATE POLICY ON MONITORING OF INTERNET
  USAGE
• PERIODIC COMPLIANCE AUDITS
• OBTAIN COUNSEL ON FEDERAL AND STATE LAWS
• OUTSIDE U.S., OBTAIN LOCAL COUNSEL CONSIDER
  AUDITS BY INTERVIEW

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CONCLUSION ARRIVE SAFELY

• INCLUSIVENESS AND FLEXIBILITY
• DIALOGUE
• INTERDISCIPLINARY PROTOCOL DRAFTING
• DRAFT TO THE USE NOT THE TECHNOLOGY
• TRAIN
• MONITOR COMPLIANCE

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QUESTIONS?

• KENNETH N. RASHBAUM, ESQ.
• RASHBAUM ASSOCIATES, LLC, 212-421-2823
• KRASHBAUM_at_RASHBAUMASSOCIATES.COM
• WWW.RASHBAUMASSOCIATES.COM