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Pharmaceuticals – Balancing Online Presence and Compliance

PharmaTweets: How to balance online presence and compliance

More people are taking their health into their own hands, and they are doing it through the power of the web. Whether to diagnose some odd symptom, skim reviews about a new drug, or investigate the implications of healthcare reform, an increasing number of adults are getting at least some health information via the Internet — a study put the number at 90% of online Americans — and the majority of those people are members of Facebook, Twitter, or both.

Drug companies eyeing social media

Given these facts, it’s no wonder that drug companies have been eyeing social media as a potentially powerful asset, but the pharmaceutical industry has been slower than others to join the online conversation. This is primarily because of concerns over FDA regulations about disclosure and fair balance. In traditional marketing, FDA requirements are met by tacking disclaimers onto the end of print ads and television commercials.  Compliance is trickier when dealing with a 140-character limit, as on Twitter.

In 2009, as drug companies began to attempt more online marketing, they requested that the FDA re-consider its standards for web communications, and a public hearing was held as the FDA acknowledged that emerging technologies may require the agency to provide additional guidance in that arena.

At the time, industry experts expressed concern that the infamous rule development process could never keep pace with online innovation, and although the agency announced the promotion of prescription drug products using social media tools as part of their Guidance Agenda, pharma companies are still waiting for concrete rules as they attempt to balance compliance with online communications.

As these issues continue to develop, there are a few basic tenets that drug companies can bear in mind while building a relatable web presence.

Be aware of regulations and conventions.

It’s important to keep abreast of the current state of the discussion and the unspoken guidelines of the twitter-verse in order to tweet effectively, writes Dan Bebear, pharma industry consultant, in his helpful article on the subject.  One resource for staying educated is Jonathan Richman’s Pharma Social Media Wiki, which aggregates all social media content created by the healthcare industry — it’s a lot of information, but that’s the whole point. Also useful is Ignite Health’s Twitter account #FDASM, comprising everything about the FDA, Internet, and Social Media. Here, drug companies can stay on top of the latest announcements, trends, and compliance issues for their industry.

Value engagement over advertisement.

Online marketing and sales still carry considerable compliance risks — so pharma companies can instead focus on creating a personable and engaging web presence, building trust and brand recognition in consumers. Tweeting about a variety of topics and including plenty of human interest, companies can reach out to the public without breaking regulations. Johnson and Johnson twitter feed sets the standard in this arena.

Implement a records retention policy.

Organizations are held increasingly liable for online content — down to every post and tweet. Keeping a non-refutable record of what was said, and when, is not a luxury but a necessity in today’s claim-skeptical environment. In case of FDA crackdown or any other legal issue, it’s essential that drug companies protect themselves with a solid web archiving policy. That’s the only way to ensure complete, legally-acceptable backup of the ever-changing corporate web presence.

For more information on how pharmaceutical’s can get full value of Twitter and other social media platforms, without the risk, check out the social media archiving page.

Online Records Retention

5 Tips For Online Records Retention

How is your business dealing with the issue of digital record-keeping and online document security? Do you feel confident that you could present your records as authentic evidence to a regulator or judge? How quickly could you locate and obtain particular records or web pages if you were asked to produce them? These are the hard questions that smart businesses will ask themselves in the midst of rapidly changing digital world. Financial companies, publicly traded companies, and even governments must recognize the need for retention solutions that are up-to-speed with today’s new technologies (also the new regulations and demands that accompany them.) If your online back-up plan needs an overhaul, keep these points in mind during the remodeling.

1. Fragmention is not your friend.

Document management and compliance experts say when it comes to digital records, companies can get bogged down in narrow issues rather than looking at the big picture. Backup systems, software options, and other management solutions can be distracting from a focus on the overall flow and efficiency of the company. Here’s the deal: you’ve got lots of online content. It all needs to be preserved impeccably if you’re to remain both compliant (to records laws) and prepared (for legal situations).  PageFreezer speaks to that comprehensive approach by providing regular and secure archiving of all your online activity — as much or as little as you specify. No fragmentation — just seamless, automatic preservation of your records.

2. Regulation compliance may not be enough.

While it’s nice to know you’re in line with SOX, SEC, or FINRA requirements, bear in mind that the risk of litigation against your company is a pressing issue that must be addressed.  Many companies mistakenly believe that being in compliance with records retention laws automatically means their records won’t be challenged in court. Not so! As noted by Financial Advisor Magazine in an article on the subject, courts are increasingly questioning the validity of digital records.

A stunning example of this is the 2005 case of Vee Vinhee vs. American Express Travel Related Services Company Inc. — in which Vinhee (who was filing bankruptcy while owing over $40,000 to AmEx) won his case without legal representation and without even attending the trial. Amex lost because the company rested its case on its internal computer records, which could not be proven authentic to the satisfaction of the court.

3. You have the burden of proof.

The example above highlights the fact that companies are being held responsible for proving the authenticity of their records. The court must be convinced of the fact that the records have not been tampered with. According to Judge Christopher Klein (in his comments on the Vinhee case), the key issue is that the record is what it purports to be.  Is your business prepared to shoulder the burden of proof in court? It’s not such a burden when you utilize PageFreezer — we put a digital signature and timestamp on every page to assure data integrity and authenticity. Plus, we employ powerful search features that help you find the exact records you need, when you need them.

4. Better safe than sorry.

Another case concerning the admissibility of online records was that of Lorraine vs. Markel American Insurance Company (dated May 4, 2007).  This suit dealt with lightening damage to a yacht that was owned by Jack Lorraine and insured by Marckel. Both sides presented e-mail evidence to support their claims, but the submissions were rejected by Chief U. S. Magistrate Judge Paul W. Grimm. He said they failed to meet the FRE standards for admissible evidence. It was a landmark ruling in the arena of digital evidence. Grimm noted in his statement about the ruling, if it is critical to the success of your case to admit into evidence computer-stored records, it would be prudent to plan to authenticate the records by the most rigorous standards that may be applied. In other words, better safe than sorry! Choose the safe route — PageFreezer preserves your archives according to the highest standards possible.

5. Delegate — and breathe easier.

The whole issue of online records retention can be a real headache in today’s ever-changing technological climate. Companies drive themselves crazy trying to stay on top of the regulations and requirements! Don’t underestimate the peace of mind that comes with delegating this matter to a reliable outside service like PageFreezer. We handle the technology and shoulder the responsibility of maintaining perfect records for your business because you have other things to do. Feel free to do them while we archive your websites — keeping your company informed, compliant, and prepared.

PageFreezer tops “Archival Acid Test”

Web archiving continues to be a critical issue as companies and organizations search for the most foolproof methods of preserving their online content. There are numerous tools and services out there, but how can you be sure which one can stand up to its claims? The primary concern is that an archived page with complex content can be very hard to capture and replay perfectly.

To investigate the strengths and weaknesses of various archiving tools, the Web Science and Digital Libraries Research Group at Old Dominion University developed an “Archival Acid Test”. The test evaluates features which modern browsers execute well, but preservation tools often have trouble handling (such as Javascript, CSS, and HTML5 content). The researchers tested five web archiving services –,, (no longer functional),, and WebCite – along with the archiving tools Heritrix, WARCreate, and GNU Wget. The findings were published by the University in a paper, which revealed that none of the tools tested were able to fully render a captured version of the elements that displayed perfectly in a live web browser (such as Chrome).

Since PageFreezer is industry-leading in its ability to capture and replay web content, we asked the group to put our service to the test. The results were telling – PageFreezer was the only tool to pass every requirement, even advanced features!

PageFreezer archiving acid test graphWhen you are using PageFreezer, you can be confident that you are working with the most advanced website archiving solution available. It makes PageFreezer a smart choice for regulatory compliance and other cases where accuracy and completeness are critical.

Archives on Demand

At PageFreezer, we believe in making website archiving easy. Really easy. That’s why we developed a user interface that puts you in charge. You can manage, edit, and fine-tune your archives without having to contact customer service or put in a request. The power is yours!

We even made it possible for you to create an instant archive of your website (or social media page) anytime you choose. This handy-dandy feature puts you in control and allows you to…

  • Save storage space. If your website doesn’t change frequently, you may choose to capture it only once per day or week. This helps you save storage space (and money). With archiving-on-demand available, you don’t have to worry about altering your archiving schedule if sudden changes are made to your site. Just take an instant snapshot and you’re good to go.

  • Be prepared for anything. Many companies archive their sites for litigation protection or regulatory compliance. If you suddenly need to produce a current copy of your website, you can do so easily, with no wait time.

  • Confidently update your website. Suppose you are working on an entirely new website, or doing a major overhaul of the one you have. You can feel confident about changing content when an instant archive is always available. This also goes for temporary pages or when you need to delete comments off your blog or social media page. No need to wait for the next regularly scheduled capture — just archive instantly and proceed with confidence!

On-demand archiving is simple to use. Here’s the breakdown:

  1. Log into your PageFreezer account

  2. Find the website you wish to capture and click “edit” on the right

  3. At the bottom of the Settings page, click “Advanced”

  4. That little button that says ARCHIVE NOW — click it!

Ta-da! Instant archive. You get a fully functional copy of your site as it exists right now, that stands as admissible evidence in court. Plus, you get that peaceful feeling that you have covered your bases before making changes to your site. And it happened with a few simple clicks. Now that was easy!