MINI SUMMIT XII. Emerging Compliance Issues in the Technology Space. Ready, Set, Go -- Is your Organization Embracing Big Data & Digital?

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1 MINI SUMMIT XII Emerging Compliance Issues in the Technology Space Ready, Set, Go -- Is your Organization Embracing Big Data & Digital? Wendy C. Goldstein, Esq. Sarah difrancesca, Esq. Stephanie Wisdo, Esq. Vicki Seyfert-Margolis, PhD Chris Bergstrom, MBA

2 Ready, Set, Go Searching for health information is the third most common online activity for every adult cohort, following and searching, (Pew Internet & American Life Project, February 2011) Every year, U.S. consumers spend almost 52 hours searching for health information online (Makovsky Kelton Survey, July 2013) Half of health information searches are conducted on behalf of someone else ( Health Online 2013, Pew Internet & American Life Project, January 2013)

3 Ready, Set, Go Pew Research Center/CHCF Health Survey, August 7 September 6, 2012

4 Ready, Set, Go Pew Research Center/CHCF Health Survey, August 7 September 6, 2012

5 AUDIENCE POLLING QUESTION In your opinion, have regulatory and compliance issues been the primary issues holding your organization back from pursuing a digital strategy? 1. YES 2. NO 3. DON T KNOW 4. NOT THE PRIMARY REASON

6 REGULATORY TIMELINE Internet Advertising / Social Media April 2009: FDA issues warning letters to 14 companies related to sponsored search ad links and banner ads May 2009: FDA releases draft guidance titled Presenting Risk Information in Prescription Drug and Medical Device Promotion that addresses internet advertising and social media November 2009: FDA hearings regarding draft guidance July 2010: FDA issues warning letter to Novartis related to Facebook share widget July 2012: FDA Safety and Innovation Act signed into law, which mandates that FDA issue social media guidance no later than 7/9/14 Ongoing: FDA enforcement letters to industry have continued, including YouTube, product websites, Facebook testimonials, metatags, etc.

7 REGULATORY TIMELINE Mobile Health Applications FDA clears at least 50 mobile medical applications July 2011: FDA issues draft guidance, Mobile Medical Applications FDA clears at least 26 mobile medical applications within first 12 months after publication of draft guidance September 2011: FTC begins shutting down mobile medical applications making unapproved claims March 2013: Congressional hearings related to FDA regulation of mobile medical applications May 2013: FDA issues warning letter to developer of a mobile urinalysis test application September 2013: FDA issues final guidance, Mobile Medical Applications Current: 33,000+ mobile medical applications, <0.2% are FDA cleared, and even fewer have demonstrated positive published clinical evidence

8 Industry Initiatives 1. Discuss your organization s online/digital business strategy. 2. What were the biggest challenges in implementation? 3. How did you overcome these challenges? 4. Describe some of the successes observed to date? 5. Has there been an measureable impact on access? quality? cost of delivering care? Discuss. 6. What are some of the lessons learned from strategy, design, launch of the different digital strategies? 7. Are there any better practices for working with internal business partners? 8. Are there any better practices for working with external business partners? 9. How do you navigate the regulatory/legal/compliance uncertainties?

9 AUDIENCE POLLING QUESTION In your opinion, do health care consumers want health care providers/suppliers to further develop online and digital strategies? 1. YES 2. NO 3. DON T KNOW

10 COMPLIANCE CONSIDERATIONS 1. Meeting regulatory requirements (e.g., fair balance, risk information) in internet advertising and social media 2. Implications of targeting physicians versus targeting patients 3. Use of real-time communications 4. Use of testimonials and case studies 5. Meeting regulatory requirements in videos 6. Posting corrective information 7. Appropriate handling of adverse events 8. Company s own social media activity (e.g., liking content) 9. Site terms of use 10. Site/data security

11 AUDIENCE POLLING QUESTION In your opinion, are there opportunities that have not been explored for stakeholders to work with regulators to advance digital strategies? 1. YES 2. NO 3. DON T KNOW

Social Media in Clinical Trial Recruitment & Retention

May 20, 2013, 4:00pm Social Media in Clinical Trial Recruitment & Retention Evan R. Hempel & Stephanie Millin 1 What is Social Media Forms of electronic communication (as Web sites for social networking