Federal Regulators Expected To Step Up Scrutiny Of Hospitals' Social Media Efforts

Source: The Sacramento Bee

WASHINGTON, July 25, 2012 -- /PRNewswire/ -- As more hospitals use social media to connect with the public, they can expect closer scrutiny by federal regulators, writes LeClairRyan attorney Michael F. Ruggio in aCorporateComplianceInsights.com column posted on July 13. He warns of growing concern that hospital employees and other representatives will inadvertently violate regulations—particularly ones introduced as part of the Health Insurance Portability and Accountability Act—as they strive to interact with the broader community via the likes of Pinterest, Facebook, Twitter and Google+.

"One of the clearest examples of the stepped up regulatory interest concerns the pharmaceutical industry, which is also subject to stiff oversight," writes Ruggio, who leads the national law firm's Healthcare Industry Team. "At the end of last year, the FDA published its first draft guidance, (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf) on the topic of social media and off-label claims about regulated pharmaceuticals."

The 13-page draft was aimed at helping companies get a handle on the FDA's position, but it was narrowly focused and may have prompted more confusion, he notes. For example, the agency lists several examples of solicited and unsolicited, public and non-public, requests, along with its view of some of the appropriate responses, but neglects to address many other issues.

In the column ("Bowing to the inevitable: Regulators are bound to scrutinize hospital use of social media tools"), Ruggio notes that even though specific social media guidelines haven't been issued by the government, "hospitals can nonetheless work with counsel to make sure their approaches to social networking comply with the spirit and letter of applicable regulations to the greatest possible extent. This is a far-better approach than a head-in-the-sand approach that proclaims 'We don't have guidelines yet, so let's just ignore this and hope for the best.'"

Some institutions, like Massachusetts General Hospital, have already moved to meet this challenge by publishing detailed social media usage guidelines for both employees and the public as part of its overall compliance efforts. Ruggio advises that one important component of an effective strategy involves ensuring that social media policies are communicated to anyone with access to a company social media account, even if they only have the ability to send an email to a consumer regarding a healthcare-related question.

"The basic point is to be conservative, knowing that social media regulations are all but inevitable," Ruggio says. "If you would not say something in a four-color brochure, do not say it in any online forum or email, keeping in mind that even a 'private' email can be posted on Facebook or other public forums. Also, keep track of the government's enforcement actions and policy statements even if they pertain to other industries, because they might offer clues about the broader concept of social media regulation."

The rise of social media has created lots of new "friends" for the hospital sector, but unwelcome or even potentially litigious guests are also part of the social media scene, he warns. "Unfortunately, you can't 'unfriend' a class-action lawsuit or 'block' a federal agency's enforcement action with the click of a mouse," Ruggio says. "The time to speak with counsel, and to review and update your policies is now, before something unfortunate happens."

About LeClairRyan

As a trusted advisor, LeClairRyan provides business counsel and client representation in corporate law and litigation. In this role, the firm applies its knowledge, insight and skill to help clients achieve their business objectives while managing and minimizing their legal risks, difficulties and expenses.  With offices in California, Connecticut, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Virginia and Washington, D.C., the firm has approximately 350 attorneys representing a wide variety of clients throughout the nation.  For more information about LeClairRyan, visit www.leclairryan.com.

SOURCE LeClairRyan

Read more here: http://www.sacbee.com/2012/07/25/4658737/federal-regulators-expected-to.html#storylink=cpy

Why has it taken pharma so long to get digital?

source: EyeforPharma

Written by Caroline Criado-Perez 

Caroline discusses some of the positive digital innovations over the past few months and questions whether or not we've heard it all before...

Another week, the beginning of another beautiful health – digital relationship We’ve had Pfizer’s online clinical trial. We’ve had Vodafone and Exco InTouch. And now, drum-roll please, we have Boehringer Ingelheim’s collaboration with Healthrageous.

BI and Healthrageous have initiated a pilot study that will evaluate the potential that digital solutions offer for improving the health of patients with type 2 diabetes. What this collaboration offers patients is clear: they will in effect receive round-the-clock care, through the use of Healthrageous’ digital monitoring system. They will receive ‘digital coaching’ and ‘a wireless glucose meter transmitting data to clinical monitors. The internet-based tool will be able to follow the effects of all shifts in the patient’s behaviour, from drug adherence, to lifestyle changes.

In Boehringer Ingelheim’s press release about their new collaboration with Healthrageous, they speak of a ‘beyond pill’ approach to healthcare. Chicago’s The Legal Examiner uses ‘Beyond the Pill’ as their headline. Dominic Tyer on PMLive quotes the ‘beyond the pill’ tagline. Everywhere you turn, ‘beyond the pill’ is being bandied about like it’s the latest, exciting new idea.

Except it isn’t. Let’s take a little trip down the old Memory Lane, shall we?

First stop, March 2011. Jonathan Richman. A little talk called ‘Your Computer is the Next Wonder Drug’. Ringing any bells? That’s right, over a year ago, Richman was talking about the need for pharm to act less like a manufacturer and more like a services company. He cited the disparity between the $60 billion spent by pharma on R&D in 2010, and the 21 new drugs approved by the FDA in the same year.

And it’s not just about money-saving either. As is explicitly stated by BI in their press release, one of the aims, and expected outcomes, of their collaboration with Healthrageous is to improve patient adherence, patient lifestyle. In short, to improve patient health – which is surely what pharma’s all about isn’t it?

OK, now let’s delve a little further back into the mists of time. A video this time (aren’t we getting all 21st century on you). A video in which those in the know refuse to get too excited about the idea of pharma’s collaboration with digital technology, because they’ve heard it all before.

Particularly striking is Dr Leandro Herrero, CEO of The Chalfont Project, who speaks of the conversation as ‘deja vu’. He laments that the idea is ‘not one that we’ve invented tonight’. Far from it. He gives a particularly enlightening example of what he means: at a talk he gave not long before the dinner, he used some slides, which had the audience nodding along enthusiastically. He then revealed that the slides were the same as the ones he had used in 2002. The message was clear: no-one was taking the initiative and making the changes needed.

Kevin Dolgin was downbeat about pharma’s ability or even appetite to engage effectively with a ‘beyond the pill’ approach. ‘Maybe pharma aren’t the people to do it’, he says. In an even more doom-laden forecast, Dave Chase compares pharma’s attitude to ‘the short-term thinking of Wall Street’, suggesting that, unless pharma pulls its digital socks up, and gets down and dirty in the big digital arena, it will follow in the steps of certain newspapers: unable to adapt to the realities on the newly digitized world, they will fall behind and eventually collapse.

Now, I know it looks like I’m being critical of BI. But I’m not – well, OK I am, a little. But only because this kind of partnership, while welcome, has taken an unbelievably long time to come about, leaving voices like Richman’s to exist as lone Cassandras in the wilderness – the lack of FDA guidelines is no excuse for lagging at least a decade behind every other industry online. It is to BI’s credit that they are finally investing properly in the digital revolution and exploring the benefits that collaborations between pharma and digital can offer patients.

So, the gauntlet has been laid down pharma. Will you answer the siren-call of the digital world?

Exploring 3 New Pharma Facebook Brand Pages

Written by Angel Xie, Engagement Planner, Ignite Health

We’ve seen a lot of buzz on the use of Facebook Brand Pages and Timeline in the Pharmaceutical world -- but up until recently there have been limited examples of companies that have taken advantage of the new format in a way to really engage the community.  For the most part, all the discussion to date has centered around how companies can effectively build relationships while operating within the ill-defined pharma regulations.  Though our industry's box might be significantly smaller, the sweet spot remains the same: establishing an emotional bond and providing useful information to the community.  Today, we wanted to take a look at a few recent examples of companies with the healthcare industry that are leveraging the facebook timeline platform to connect with their audiences.

• PsoriasisSpeaks (Abbott)
• Our Hemophila Community (Pfizer)
• Medtronic Diabetes (Medtronic)

PsoriasisSpeaks seems to have established their social presence very recently. While still in the beginning of building their empire, the Facebook brand page is tightly linked to their core unbranded disease education Website Psoriasis.com. With tabs featuring its signature "Patient Advocate Program" and clearly identifying the CTAs, it is hard to get lost in the space. 

The more interesting highlight of the page is its community management. The ground rule is set as “This page is for US audiences only. Mentions of specific doctors’ names, product names or potential side effects will be removed”.  People are encouraged to participate in the conversation under such rule, and the feedback from community managers has been quite timely and personalized. While the brand continues to experiment with its content strategy and fulfill its social ecosystem, it would be interesting to play with ideas like such:

1. Leverage its Advocates program and extend the connection beyond phone and email into Social
2. Respect the fact that people may be embarrassed to share with their social circles about such conditions – there is a need to allow privacy settings and emotional support or education.

Comparing to the prior, Abbott's Our Hemophilia Community is a much more tightly-managed space -- no comments are allowed at all. The platform is mainly used to broadcast contents from Pfizer’s product brand sites (BeneFix & Xyntha) and its affiliated Hemophilia Village, which we thought was quite interesting as it may give precedent to other brands for connecting unbranded social to branded.

The ISI (Important Safety Information) is listed as top priority on the tabs, as recommended by many healthcare best practices. We were quite disappointed to find the Community Connections and Resources pages to be out of order -- being the gateway to its comprehensive contents on Hemophilia Village. As we respect brand’s choice of restraining comments on social media, there is definitely room for improvements on streamlining the ecosystem journey via deeper integration of site contents on

brand pages:

1. Feature story videos or resource links on timeline with thumbnails for higher engagement
2. Experiment with consumer-centric approach of content strategy, instead of information on the higher priority list for business.

With a fully implemented ecosystem, the Medtronic Diabetes Facebook page exhibits a robust social presence. With content integration at the tabs level, one can easily navigate all contents without leaving the Facebook page. Content updates are updated frequently and personal. The brand has clearly established a strong persona with vivid characters through these real life stories on its timeline. 


The fan base is strongly united and regularly shouts out support to cheer the each other up. Community management is relatively open with rules clearly labeled on its top tabs. Similarly to PsoriasisSpeaks, feedback appears to be timely and personal. With such a good social etiquette, it's no surprise to see 36,771 "likes" and high engagement rates. While we love the content, our recommendations are related to the ecosystem structure and User Experience (UX): 

1. Integrate its branded YouTube channel with its Facebook Page under the “Video” tab
2. Provide more navigation guidance within the "Patient stories" section, especially for new
   fans.

Social technologies can provide brands with tools to innovate their communication in all kinds of way; however, the real value today is to use these technologies to do something remarkably simple: enable natural human connections.   As healthcare agencies, we need to embrace these tools more than anyone else out there.   As long as we always put ourselves in the shoes of the patient, we will always have a compass that can help us understand what "good" looks like.   "True North" is always governed by the same principle regardless of the industry we operate in: Do The Right Thing.