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?

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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

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

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

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.

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

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 BlogPodcast 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.”

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