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

Facebook Venturing into Healthcare

Facebook venturing into healthcareFacebook venturing into healthcare was predictable.  Apple, Google are doing it and there is a plethora of niche platform doing it.

Facebook already knows us in more intimate ways than we sometimes know.  They know what we like, who our friends are, they know what we share, they certainly have been following and recording when we share our medical conditions, health concerns and health initiative.

They also follow anything happening on their platform and there is no doubt they have noticed that patients have created a number of communities (private and public support groups based on health conditions, they are also keenly aware that studies have shown that these support communities in and out of Facebook are very active and engaged, in spite of Facebook dubious reputation when it comes to privacy

As Facebook mentioned, most Instagram users do not know Instagram is owned by Facebook and they are hoping their health care ventures will follow a similar path with patients ignoring or being unaware of the link between Facebook and the community.

How do you feel about sharing intimate health information in communities run by Facebook or on a Facebook owned platform?

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Physician Reviews: Patient Experience Trumps Skills

physician reviewsHow important are physician reviews

In healthcare, branding sometimes is reduced to its most basic component and it’s not what most physicians would thing about first.

Unless a patient is victim of malpractice, it’s very difficult for them to evaluate a physician medical skills.

On the other hand, patients have expectations in terms of experience and oftentimes, that experience will drive their perception of the physician or the healthcare facility.

According to a recent study of physician review websites released in April 2013 by Vanguard Communications, poor customer service and bedside manners are the biggest complaints on online medical review sites, trumping by far poor medical skills

  • 43.1 percent of the negative reviews complained about doctor indifference and bedside manner
  • 35.3 percent were about poor customer service including staff rudeness, erroneous billing, unprofessional dress and facilities not being hygienic.
  • 21.5 percent highlighted a lack of physician skills

To stand out of the crowd, just like any business, healthcare professionals need to start thinking about their brand holistically, in term of patient experience from beginning to end.

What does that mean?  That means evaluating and improving each point of contact with the patient, from the website, social media, printed material, telephone demeanor, front office staff,  assistants, nurses, bedside manners, parking lot, waiting room … to improve patient and caregivers’ experience

Think in term of great experience and patients and caregivers will flock to review sites and sing your praise.

What’s in it for you? Increasingly patients are going online for healthcare information and  to choose healthcare professionals based on peer reviews and referrals.

In addition, positive reviews improve your website organic search rankings which in turn, means better visibility and more patients and referrals.

There is no downside

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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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

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.

AMA Social Media Policy

Professionalism in the Use of Social Media

The Internet and social media in particular, have created the ability for medical students and physicians to communicate and share information quickly and to reach millions of people easily. Participating in social media, social networking and other similar Internet opportunities can support physicians’ personal expression, enable individual physicians to have a professional presence online, foster collegiality and camaraderie within the profession, provide opportunity to widely disseminate public health messages and other health communication. Social media, blogs, and other forms of communication online also create new challenges to the patient-physician relationship. Physicians should weigh a number of considerations when maintaining a presence online:

(a) Physicians should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online, and must refrain from posting identifiable patient information online.

(b) When using the Internet for social networking, physicians should use privacy settings to safeguard personal information and content to the extent possible, but should realize that privacy settings are not absolute and that once on the Internet, content is likely there permanently. Thus, physicians should routinely monitor their own Internet presence to ensure that the personal and professional information on their own sites and, to the extent possible, content posted about them by others, is accurate and appropriate.

(c) If they interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just, as they would in any other context.

(d) To maintain appropriate professional boundaries physicians should consider separating personal and professional content online.

(e) When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.

(f) Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession.

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