Category: Social media in regulated markets

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HIPAA Often Misinterpreted

HIPAA mythsIntended to keep personal health information private, the law does not prohibit health care providers from sharing information with family, friends or caregivers unless the patient specifically objects. Even if he or she is not present or is incapacitated, providers may use “professional judgment” to disclose pertinent information to a relative or friend if it’s “in the best interests of the individual.”

Hipaa applies only to health care providers, health insurers, clearinghouses that manage and store health data, and their business associates. Yet when I last wrote about this topic, a California reader commented that she’d heard a minister explain that the names of ailing parishioners could no longer appear in the church bulletin because of Hipaa.

Wrong. Neither a church nor a distraught spouse is a “covered entity” under the law.

Last month, Representative Doris Matsui, Democrat of California and co-chairwoman of the Democratic Caucus Seniors Task Force, who has heard similar complaints from constituents, introduced legislation to clarify who can divulge what and under what circumstances. The proposed bill would require the Department of Health and Human Services, which last year issued new Hipaa “guidance,” to make that statement part of its regulations and to create model training programs for providers and administrators, patients and families.

“A lot of times it’s just misunderstanding what is and isn’t allowed under Hipaa,” Representative Matsui said in an interview.

So, what is and isn’t?

Learn more

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FTC Social Media Endorsements Guidelines

FTC endorsements guidelinesEndorsements and reviews are big in social media, they can be effective decision making tools for consumers if they are truthful.  the FTC published endorsement guidelines to help brands and businesses stay out of trouble

Suppose you meet someone who tells you about a great new product. She tells you it performs wonderfully and offers fantastic new features that nobody else has. Would that recommendation factor into your decision to buy the product? Probably.

Now suppose the person works for the company that sells the product – or has been paid by the company to tout the product. Would you want to know that when you’re evaluating the endorser’s glowing recommendation? You bet. That common-sense premise is at the heart of the Federal Trade Commission’s (FTC) Endorsement Guides.

The Guides, at their core, reflect the basic truth-in-advertising principle that endorsements must be honest and not misleading. An endorsement must reflect the honest opinion of the endorser and can’t be used to make a claim that the product’s marketer couldn’t legally make. Continue reading “FTC Social Media Endorsements Guidelines”

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Social Media Guidance For Physicians

Social Media Guidance For PhysiciansLack of social media guidance for physicians

Professionals in healthcare have been slow to embrace social media and one of the reasons is the lack of social media guidance for physicians.  Physicians face a number of issues related to compliance (HIPAA and in some cases FDA), maintaining trust in the patient/physician relationship and the integrity of the profession

Professional associations steps in

In some cases, professional associations, concerned with the potential negative impact of social media  on the profession at large, have tried to fill the gap and issued guidance.

One of these associations, the American College of Physicians offers physicians a set of social media guidance to explain the pros and cons of social media as well as issue recommendations and safeguards for the proper use of social media

The goal of the recommendations being to preserve the trust in the patient/physician relationship and the integrity of the profession.

Recommendations and guidelines Continue reading “Social Media Guidance For Physicians”

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FDA Cracking Down on Facebook Marketing

FDA craking down on FacebookThe FDA cracking down on Facebook marketing is a clear signal that companies have to treat Facebook the same way they would treat any other media they use in their communication with the public

In the past 6 months the FDA has issued 6 warning letters mostly for unapproved claims but when it comes to unapproved claims social media creates a unique challenge for companies in the healthcare industry at large (that includes manufacturers and distributors of supplements and other products not usually considered drugs or medical devices but could be construed as related to health) in that comments posted by third parties can also be construed as claims and the simple fact of liking a comment constitutes an endorsement of the claim by the owner of the page Continue reading “FDA Cracking Down on Facebook Marketing”

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What Worries Compliance Officers?

what worries complaince officersWhen it comes to regulated markets, compliance is a major issue, especially when it comes to social media, it worries compliance officers and has held back the use of social media in regulated markets.

So, what keeps compliance officers up at night and what do they do about it.

In short, anything posted on social media is amplified and can have an impact on the brand and the reputation and once the cat is out of the box, getting it back in the box is rather difficult.

As Warren Buffet said:“It takes 20 years to build a reputation and five minutes to ruin it.”

Of course, there are ways to mitigate risk. For one thing, a social media policy explaining who can post on social media sites, how they post and what they can or cannot say, what requires compliance approval before posting.  Yous social media policy should also define the steps to follow in case of crisis

The other challenge is what employees post about the company on their personal social media accounts.  Their post can be perceived as representing the views of the companies and can have an impact on the company reputation and/or have repercussions from the regulatory authorities

What makes it even more challenging is that be it in healthcare or financial services there are no set social media rules.  The regulatory authorities (FDA, FINRA, SEC, OCC and others) have not created a framework to regulate social media, they have only issued guidance on how to apply traditional communication with the public regulations to the electronic era and social media. The guidance seems to be a lot clearer though in the financial markets; in the medical market, the FDA is still going back and forth and the guidance can be confusing at best.

In addition, social media platforms are diverse and so are the posting modes and the number of character allowed creating challenges especially when it comes to disclosures.

Read more about what keeps compliance officers awake in financial services.

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FDA Social Media Guidance Controversy

FDAUnder the new FDA social media guidance, manufacturers would be responsible for monitoring their social media platforms for comments considered inaccurate, misleading or related to non approved or off label use.

They would also be liable when third party websites they have collaborated with publishes or do not filter articles, posts, ads or comments considered inaccurate, misleading or related to non approved or off label use.

All three major industry trade associations – the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed) warn FDA of significant flaws in the agency’s proposed regulations on the use of social media.

Their contention being that information and comments published online by third party comes under the first amendment and they should not have to monitor, correct or remove them even if they are misleading

The first amendment argument has been widely used to justify misleading information in non regulated industries but in the healthcare industry, misleading information, even by third party can have wide ranging consequences on the health of patients, raise false hope and create undue pressure by ill patients on doctors. Continue reading “FDA Social Media Guidance Controversy”

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Mayo Clinic: Gold Standard for Social Media in Healthcare

mayoThe Mayo Clinic is the gold standard for the use of social media in healthcare organizations. The Mayo Clinic Center for Social Media [MCCSM]–yes, they have a whole center dedicated to social media–facilitates the use of social media throughout the Mayo Clinic and also works to help other hospitals, professionals and patients use social media to promote health education, health literacy and healthcare delivery worldwide.

The Mayo Clinic has the most popular medical provider channel on YouTube and more than 450,000 “followers” on Twitter. They also an active Facebook page with over 300,000 connections. A pioneer in blogging, Mayo has a News Blog, Podcast Blog and Sharing Mayo Clinic, a blog that enables patients and employees to tell stories about their Mayo Clinic experience.

Lee Aase is the Director of the Mayo Clinic Center for Social Media. Lee has a background in politics and media relations and has led the Mayo Clinic into the forefront in healthcare social media.

When asked what his approach to social media marketing was, Lee answered that healthcare consumers want and need in-depth information and it is his job and the Mayo Clinic’s job to offer them that information. “The main idea is to understand that there is a thirst for information out there,” said Lee. “When people get sick, they want information and they want it right away.”

Read more

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FDA: No Unsubstantiated Claims, Even on Social Media

No Unsubstantiated Claims on social mediaIn case some wondered, FDA guidelines apply on social media as well and liking a post from one of your followers promoting unsubstantiated claims is an endorsement of those claims.

In December 2012, the FDA sent a warning letter to Amarc Enterprises regarding two websites. This letter has garnered attention because it references Facebook. The FDA details a variety of serious concerns over the way Amarc is marketing their vitamins, in particular their websites have numerous testimonials that are unsupported by clinical data.

For example, “PolyMVA helped save my life. I began a regimen of PolyMVA… After 3 months, the Stage 2 cancer was down to Stage 1.” These vitamins have not been approved by the FDA and are being improperly marketed as drugs. Similar claims were made for pets using the products and the FDA notes that this is also a violation.

Here is what the warning letter says about Facebook: “We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims: In a March 10, 2011 post which was ‘liked’ by ‘Poly Mva’:

  • ‘PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation… Thank you AMARC’”

The product’s Facebook page has been taken down, but it appears that the claim was posted to the wall. Not only was the claim left on the wall, it was “liked” by the page administrator which would be a clear endorsement of the claim. The letter also mentions a blog post on the Amarc site that makes claims that are unsupported by scientific data.

Interestingly, their other Facebook page is still live and posting things like this: “THE BINDING OF PALLADIUM, A RARE TRACE MINERAL, WITH ALPHA LIPOIC ACID, A POWERFUL ANTIOXIDANT, DRAMATICALLY INCREASES NUTRIENT ABSORPTION AT THE CELLULAR LEVEL AND THROUGHOUT THE BODY – A BREAKTHROUGH THAT DISTINGUISHES POLY-MVA® FROM ANY OTHER SUPPLEMENT!”

I posted a link to the FDA warning letter on their wall and asked for a response. They replied, “Discussions with the FDA are ongoing and the issues raised are being addressed. AMARC is committed to our products and working with health agencies in complying with any applicable rules and regulations. This is somewhat of a normal review in the industry. Thank you for the inquiry and we will continue to support our clients and our products.”

Follow existing guidelines
It’s clear that these websites, the Facebook page and blog provided no clinical data to support any of their claims. This warning letter isn’t really about Facebook or blogs, but about following existing guidelines. The FDA is very clear on labeling and how companies can promote their products. Companies that continue to follow this guidance (on websites, Facebook and blogs) should be fine

Original article

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Social Media Helps Life Technologies Improve Business

Life Technologies’ global senior e-marketing manager for search and social, Robin Smith, explains how the deep relationships the company makes with its fans help influence the products the company makes and how it does business. Their approach is a sustainable way to actively make business better with social media.

Some of her key points:

  • Customers relate to a person, not a company. Making real, human relationships with individuals, as individuals, is key to earning your fans’ trust and opinions. Smith says Life Technologies works hard to let employees have their own voice in social media.
  • A lot of employees shy away from engaging online because they’re afraid of screwing up. Smith explains how the brand helps anyone from an executive to a product manager feel comfortable contributing
  • Social media can change how you do business. Smith talks about how social helped the company launch a product and even come up with a name for it. She explains how your social media fans can be a great resource if you take time to cultivate great relationships.

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Healthcare Company Kaiser Permanente Leverages Video

Healthcare company Kaiser Permanente’s director of digital media and syndication, Vince Golla, talked about how the company brought its fans’ genuine, unscripted stories to a bigger audience without hiring an expensive production company.

Some key takeaways from his presentation:

  • You can’t sample healthcare. Kaiser Permanente needed to show people in compelling, honest ways reasons customers love the brand. So the company turned to video testimonials and spotlighting the people who make it great: its staff.
  • Your videos don’t have to be perfect. Golla says to keep the video blog sustainable, the company had to pull production off on its own. So the company hired an indie filmmaker to show the staff some basics and an intern to teach them how to edit it.
  • Make your great content usable everywhere to get the most out of it. Kaiser Permanente didn’t stop at posting videos in social media. The healthcare company played them in waiting rooms, at meetings and on its internal channels to build pride in the content, while still spreading the word.

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