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FDA Cracks Down on Online Claims

The FDA is cracking down.

It’s been a tough year on the advertising front, at least for food and drug companies.  As part of an Obama-backed, pro-active approach to regulation enforcement, the Food and Drug Administration has been cracking down on product information and claims. As a result, a number of companies have received warning letters indicating that certain of their marketing claims on their websites are not compliant with the FD&C Act, particularly section 403(r)(1)(A).

Presumably, everyone supports the idea of advertising with integrity and honesty — but regulators and marketers often have differing views about what language is permissible.  What do the companies themselves say?  Many companies will probably object to the FDA’s statements. And that’s where PageFreezer comes in.

Not because we are lawyers (we aren’t), and not because we have any authority over the rules and regs of marketing claims (we don’t) — but because PageFreezer can provide defensible, accurate records that verify the exact online activity of any of our clients on any given day. This eliminates one man’s word against another and ensures that our clients have easily-accessible archives that can be viewed as if they were live.

Think it won’t happen to you?

In a modern claims-skeptical environment, many businesses will have to answer challenges about their marketing vocabulary, as was recently noted on a health news website. The same article quotes Ivan Wasserman, a Washington DC-based advertising and labeling attorney at Manatt Phelps & Phillips:

Even for companies working diligently to accurately communicate the health benefits of their products, it seems like it is becoming almost inevitable that if you have success in the market at some point you will find yourself defending a class action.

We have the tools you need.

PageFreezer is proud to offer an innovative solution to the pressing issue of regulation-compliant website archiving. We provide a digital timestamp and digital signature to each archived page, as required by the FDA’s 21 CFR Part 11 guidelines. So our clients have the security of defensible evidence when it comes to the contents of their websites.

The FDA and the marketing departments may disagree on the definition of acceptable advertising.  And no one can agree as to the motivations behind the endless litigation.  But everyone can agree on the benefit of reliable website record-keeping — brought to you by PageFreezer.

Going Gov 2.0? Keep it Legal

In the fast-paced, tech-based culture we live in now, many local governments are finding it essential to communicate and relate with the public on entirely new levels and in creative new ways. They want to be more accessible,more focused on problem-solving, and — perhaps most importantly — more interactive.

The Gov 2.0 movement is a result of this mentality, and now we have the mayor on Twitter, RSS feeds on the municipal website, and citizen-driven community improvement platforms on our mobile phones. Exciting and innovative? Yes. Somewhat intimidating? Yes, indeed.

Government agencies are jumping on board with all manner of citizen-empowering technologies, but not without some hesitation. The main concern for a government of any size when it comes to advancing technology is this: What are the legal risks associated with these innovations? Are we covering our bases in case of investigation or litigation? In the world where information is so easily disseminated and always changing, how can we maintain the integrity and perpetuity of our website?

Smart government agencies realize that their websites are public records, and are concerned with maintaining official archives as required by law. But how is that to be done efficiently given the complex, transitory nature of websites today?PageFreezer is providing the answer: regular online archiving of web pages that include a digital signature and timestamp to every page. Data integrity and authenticity are assured, the archives readily accessible for viewing anytime, and no installation or software involved.

Even for cities that have Flash files or other interactive media on their sites, PageFreezer is on the job. We can archive all content to be replayed at a later date, exactly as if it were live. Knowing that web pages are automatically stored in a manner compliant with record retention laws, government agencies are free to enter the cutting-edge world of Gov 2.0 without fear. They can focus on what’s really important – relating to and empowering citizens – while leaving the legal stuff to us.

Dustin Haisler, CIO, and Asst. Manager of the radically forward-thinking city of Manor, TX, employed PageFreezer in his recent Gov 2.0 Makeover of another Texas city that needed a push forward. Along with a website facelift, a handy citizen-reporting platform, and several other innovations, the city of De Leon, TX began archiving its online activity with PageFreezer to ensure compliance with all legal requirements. “Emerging social technologies allow us to interact with our citizens in very exciting and meaningful ways, says Haisler, who is a leading evangelist of the benefits of technology to local governments.However, legal constraints sometimes restrict our ability to experiment in these new channels of communication. Using PageFreezer, we’re able to not only experiment in these new channels but also stay compliant with record retention laws.”

Being aware of the legal implications of modern technological advances, and acting on that awareness, is an indispensable step in the process of becoming a dynamic, citizen-empowering government agency. It’s a step you can’t afford NOT to take. Let PageFreezer handle records retention, so you can get on with the business of interacting with and relating to the people of your community.

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.

SEC-ready Social Media Records

4 tips for keeping your social media records SEC-ready

How long has it been since your firm revisited its compliance policies?  Are your recordkeeping programs effective for newer, evolving platforms like social media?  Are your advisers prepared with complete and reliable records of online business communications, including social media content?

It’s been eight months since a social media fraud incident caused the SEC to issue warnings about investment adviser use of social media for business communications.  The case involved an Illinois-based adviser, Anthony Fields, offering over $500 billion in fictitious securities through social media websites.  According to a news release issued by the SEC, Fields also “failed to maintain required books and records, did not implement adequate compliance policies and procedures, and held himself out to be a broker-dealer while he was not registered with the SEC.”

Immediately following these events, the SEC released a risk alert for “Investment Adviser Use of Social Media”, which urged advisers to evaluate the effectiveness of their compliance programs.  Social media, noted the alert, is “landscape-shifting” because it allows for user-generated content and is much harder to capture for books and records purposes.  Advisers were particularly cautioned to pay attention to “third party content and recordkeeping responsibilities.”

So what are the recordkeeping responsibilities firms should be aware of?  

In evaluating your compliance policies and choosing an archiving solution, it’s critical to understand what is expected by industry regulators like FINRA and SEC.  To help you evaluate your current policies, consider these best practices of recordkeeping for firms.  Ask yourself: is your social media content being managed in accordance with these directives?

1. Records should be managed so that they can be reproduced in a timely and complete manner.

(2006 changes to the Federal Rules of Civil Procedure)

A simple backup or screen shot is not sufficient. Without the ability to organize and search company records, finding a specific page can be like finding a needle in a haystack. Firms must consider whether their data can be quickly presented to a regulator in case of litigation or e-discovery proceedings.

2. Records must be preserved in whatever medium they were originally produced.  

(Required by the Investment Dealers Assoc. of Canada, FINRA, and the FRCP)

The regulations currently in effect for business records are being extended to all electronic communications, including websites and social media. Firms are responsible for retaining and retrieving these records no matter where they occur. Also, they must ensure that retrieved data can be presented as a perfectly accurate reproduction including clickable links and playable video.

3. Some records must be kept for periods of up to seven years.  

(Required by SEC, FINRA, IDA of Canada, FSA of the UK, and the Sarbanes-Oxley Act of 2002)

Nearly every specification for record-keeping in the financial sector requires that data be preserved for long periods of time. Your social media communications are transient by nature. To remain compliant with regulations, they must be captured in such a way that their contents can be reproduced accurately, months or even years later.

4. Records must bear proof of data integrity and authenticity.

(Required by the Federal Rules of Evidence)

Besides complying with the retention requirements of financial services regulators, firms must be aware of how digital evidence is viewed in court, should they be involved in litigation or e-discovery proceedings.  Electronic evidence must bear a digital signature and timestamp to prove that the data in question was indeed online at the alleged time, and that the data in question has not been altered.

Understanding the rules for compliance is critical if firms are to engage using social media.  According to Carlo di Florio, Director of the Office of Compliance Inspections and Examinations (OCIE):

“As investment advisers increasingly utilize social media to communicate with clients . . . firms need to be mindful of the applicable standards governing those communications.”

But if advisers are careful to review their policies and ensure that digital communications are captured and retained properly, they can freely reap the benefits of doing business online.

Legal Implications of Twitter

As legal implications of Twitter skyrocket, is your company prepared?


This year has already seen multiple cases of social media fiascoes — the kind where a record of online content becomes the key to a whole criminal case or the basis for a lawsuit. It’s these cases that remind us of how vital social media has become to our communication, and how transient is the information that passes through those channels — unless it is caught and preserved. Individuals and companies alike must consider the possible legal implications of their own online conversations.

Social media matters in court.

Of all social media, Twitter is the most talked-about, likely because of the sheer volume of chatter that passes through it each day. 140-character missives, thousands of them per second, fill the social media space with all kinds of mostly innocuous information. But sometimes a single tweet skyrockets in legal importance, rising to the status of a public record or criminal evidence. It’s hard to predict when that will happen, or if your company will be the next one to suddenly wish it had irrefutable proof of exactly what it did (or did not) publish online.

Be prepared with defensible archives.

As subpoenas of social media content increase, be aware that your tweets may be required in court, especially as more companies are allowed to publish market-moving information and the market reacts to social media content. The information that passes through Twitter and other outlets can be misconstrued, misrepresented, or simply lost in translation. It can be used against you in a court of law, or thrown out when you were depending upon it as evidence. It can be requested by an opposing party, a regulator, or a judge.

If companies intend to use social media to communicate with customers, shareholders, and the world, they must take responsibility for their published content by keeping verifiable records. This presented a challenge in the early days of social media, but the technology now exists — in the form of web archiving — to capture and preserve even large volumes of social media content.

Take steps to make sure your posts are not lost as they slide past on Twitter or Facebook. Establish a social media policy that includes guidelines on capturing and preserving online conversations. Then, if the court comes knocking — you’ll be ready!

Are your tweets court-ready?

What’s in a tweet? Recent cases have shown that social media posts carry more weight in court than one might suspect. It’s not only individuals that need to worry about what they post online — companies and agencies are held accountable for their social media activity too. As digital content rises in legal importance, organizations must take notice.

If you had to produce records of your company’s tweets between certain dates, or your Facebook posts on a certain topic, would you be able to do it? And if you could, are you certain they would be accepted as evidence in court?

You CAN be assured that your tweets are court-ready if you follow a few simple guidelines:

Daily capture.

Don’t miss a thing! Make sure your company employs a retention solution that captures your social media content at least daily. Lost tweets or comments are potentially lost evidence — which could lead to charges of spoliation. The transient and real-time nature of social media does not release companies from the responsibility of preserving it. As recently noted in an article from Martindale-Hubbell:

“Recent jurisprudence is clear: social media information is potentially both relevant and discoverable.”

Proof of data integrity and authenticity.

What if you are required to produce social media records for a court case? How can you be sure the data will be accepted as authentic? CNN reports:

“Legal experts say photos and videos . . . must be authenticated, meaning the prosecutors must prove the images are what they seem and have not been altered or staged. And they can’t be shown out of context.”

This certainly applies to digital evidence in the form of social media posts and any associated content. It’s a modern-day application of Rule 901 in the Federal Rules of Evidence. If digital files are presented in court, the presenter must prove that the files were online at the time alleged, and that they haven’t been altered. This is called “proof of data integrity and authenticity”.

For digital content, the golden standard for proving data authenticity is a digital timestamp and signature. Your chosen solution for preserving web content should provide these “digital fingerprints” if you want your archives to stand as evidence in court.

Secure, searchable storage.

It goes without saying that your social media files should be preserved securely. You want to ensure the safety of personally identifiable information and other sensitive information. In addition, it’s helpful if your archives are searchable. In the event of ediscovery, regulatory request for information, or your own company analytics, having searchable social media files will simplify and accelerate the process — saving time and money.

Don’t assume your social media content is private or irrelevant — recent cases have proven the opposite. But companies and agencies can continue to engage successfully online, as long as they preserve their social media records as faithfully as they would their traditional records.

Tools for social media records

Do you have the 2 must-have tools for perfect social media records?

The jury is no longer out. Social media posts are business records. Though industry regulators vary on how long to keep them, social media posts are a vital piece of your company’s online history and must be preserved as such. Failure to retain social media content can result in sanctions, increased costs, and damaging of brand reputation.

That goes for government agencies as well. The public is counting on you to preserve faithful records of your conversations with them. Even if the lifespan of a post is only a few seconds, the statement has become part of your agency’s history by being posted publicly. Sometimes the short-lived posts and comments become the ones that matter most. If you allow social media content to be lost or deleted, you may be caught unprepared by FOI requests or investigations.

Fortunately, there are two key technologies that corporations and government agencies can employ to ensure they are prepared for any request for digital records:

real-time archiving and powerful search functionality.

With real-time archiving, records managers can rest assured that every post, comment, tweet, and update is captured. Rather than getting a snapshot of their social media page once per day, companies using real-time archiving are assured of a separate archive for each change that is made on their Twitter or Facebook profile. This is critical in court cases or FOI requests, when the details of “who said what, and when” become legally relevant. Real-time archiving ensures a full capture of social media activity, even if a post is quickly deleted.

Once you have thorough records of your social media activity, you will need powerful search functionality built into your archiving solution. Digging through digital records can be a drain on resources, especially if your records managers are not accustomed to responding to requests for digital information. The ability to slide through a timeline of your social media posts, narrow a search by keyword or date, and even perceive patterns in your social media activity are all valuable tools to help you dig up the exact post you need.

So, never fear. Even though digital records have grown ever more complicated with the explosion of social media use in business and in court, your company or agency can be prepared by investing in an archiving solution that covers your needs — from your most popular posts to your deleted tweets.

Web Archiving as Legal Tool

How Web Archiving Can Be Your Most Powerful Legal Tool

Web and social media archiving have become indispensable for companies that need to comply with retention regulations like those Freedom of Information laws to preserve their online records and conversations. Web and social media archives are also key for companies in litigious industries, as the use of online content is becoming ever more common as evidence in court cases.

Besides being used as a defensive tool against regulation and litigation, web archiving can also be used proactively for many legal applications. The ability to capture an exact copy of ANY published digital content and store it in a searchable and secure database has unexpected legal advantages. Consider unleashing the potential of digital data capture in the following ways:

  • Early case assessments: Companies can peruse archives to determine the potential liability of cases before they go to court (e.g., wrongful termination, online harassment, etc.)
  • Federal Rules of Civil Procedure: According to Rule 34, responding parties must produce requested information within 30 days.  Searchable archives simplify this process for web content.
  • Web content dispute resolution: Using archives, companies can quickly resolve disputes concerning website content, domain names, or false claims — saving time and money.
  • Online error management: In dealing with mistakenly published content (e.g., products listed for the wrong price), companies can use archives to easily identify the time frame of the mistake and quickly resolve claims relating to it.
  • Monitoring of offending parties: Archiving the web content of offending parties provides a digital portfolio of information about the opposition, and provides evidence for cases relating to web content (e.g., copyright infringement).
  • Protecting digital assets: Snapshots of web content can be filed with regulators like the US Trademark Office to create a digital record of a company’s online assets.

The great thing about archiving is that you can “set it and forget it”. Determine what websites or social media you need to capture for your legal advantage, then let the technology work for you. A good archiving solution will enable you to capture only specific pages or URL paths — saving storage space and money. Make sure your archives are marked with a digital timestamp and signature to ensure their admissibility in court. Then you can enjoy the legal edge that web and social media archiving can provide for your company.

Social media mistakes

Is your company making the worst social media mistake?


We know.  Social media has grown so quickly, been adopted so widely and become so universally recognized as a viable means of online communication for businesses . . . it has left your company’s proverbial head spinning.  Keeping a lid on employees’ personal usage of social media at work is hard enough.  And now, across industries, organizations are creating their own social media presence, often without a clear idea of how to balance risks and rewards.  How were you supposed to keep up with it all?

Hopefully, you have thus far avoided the major pitfalls that can come with adopting social media as an organization — embarrassing PR gaffes, compliance issues, or legal tussles — but is your company committing the worst social media blunder of all?  To avoid this one supreme mistake is to avoid dozens of other potential disasters.

It is the mistake of embarking on social media as a company — without a social media policy.  No clear guidance for personnel on how to engage with the public on behalf of the company, or how to maintain their personal social media activity in a way that upholds the company image.  No outline of the legal do’s and don’ts; no suggestions for creating worthwhile content.  And a staggering 76% of companies make this mistake, according to a recent study.

We understand that many organizations have been taken unawares by the social media storm.  But investing time in developing a good social media policy will pay great dividends by allowing your online communications to flourish without the worry of legal or public relations disasters.  A social media policy doesn’t have to be complicated.  Certain industries will have more to cover than others, but in general you simply need to outline that social media content from your company should remain respectful, honest, law-abiding, and relevant.

Make it easy on yourself by downloading one of these Social Media Policy templates — a variety of examples to choose from — and tailor it to fit the needs of your organization.  Also, check out these helpful tips on developing a good social media policy.  There’s no reason to proceed any further in your social media journey without the security of a policy to keep everything legit.  It won’t solve all your problems, but it will prevent a good many of them!

Don’t forget that in addition to your policy which directs the use of social media within the organization, you will also need to have a plan for preserving your social media records since they are part of your business records.  Copies of your social media activity may be requested for litigation or regulatory purposes, especially if you are in the financial, pharma, government, or legal industry!  But we’ve talked about that elsewhere.

Prevent problems with social media usage before they start.  Develop a social media policy that’s simple and clear, allowing your personnel the freedom to represent your company online within parameters that will keep everyone in the conversation . . . and out of trouble.

Prevent Social Media Scandals

Three smart tips to prevent social media scandal

Social media scandal. It’s a dreaded thought for any communications manager. And it seems that more cases of social media missteps are published every week. Most recently, there was a public outcry against the Latah County Sheriff’s Office, which published a flippant Facebook post about a young man, wanted for several crimes, who subsequently committed suicide. It was a sad story which again raised questions about organizations using social media to communicate with the public. Do the benefits outweigh the risks?

Despite stories like the one mentioned above, it is possible to effectively use social media as an organization. But there are specific steps that should be taken in order to prevent mistakes, and to handle them properly when they do happen.

  • Have a social media policy and inform employees of the rules.

Social media’s explosive growth caused many companies and agencies to become active on social networks without taking the time to develop and implement social media policies. We would be willing to bet that the Latah County Sheriff’s Office did not have a social media usage policy — or if it did, that the guidelines were violated by the recent controversial post. Having a policy in place allows your employees to engage with customers, while preventing thoughtless posts. Not sure where to start on your policy? Here are some excellent tips on how to write one.

  • Apologize for mistakes, but don’t reactively delete posts or comments.

It’s a guarantee — something will eventually show up on your social media feed that doesn’t reflect well on your company or agency. Whether it’s a poorly-composed post by your company, or a negative comment from an upset customer, the temptation to delete can be strong. But deleting posts or comments (or your entire Facebook account, as the Latah County Sheriff’s Office did in the wake of the scandal) is never a good idea. It can lead to charges of spoliation of evidence in court, or damage your company’s reputation for integrity. Instead, apologize for mistakes and respond calmly to negative feedback. Then your social media will be an honest reflection of your company’s communication with the world.

  • Capture and save all social media content, in case of litigation or records request.

There may be times when you do need to remove content from your social media page — for instance, in the case of spam or wrong information — and you should be prepared to keep records of the content even after it’s deleted. For the sake of regulatory compliance, open records laws, and just plain common sense, every organization should employ a solution to capture ALL their social media content and preserve it in a secure, searchable format. That way you can safely delete content while retaining a record of it.

None of us expect to be be involved in the type of social media scandal that has overshadowed the Latah County Sheriff’s Office — but the truth is, the Digital Age has added a new level of liability to public communications. The steps outlined above will empower you to prevent and handle social media mistakes, so you can continue to engage online with confidence.