Category: Communication Media & Internet

Fashion Documentaries: A Fashion Do

Sheppard Mullin 2012

 

Since the first major fashion documentary featuring designer Isaac Mizrahi, “Unzipped,” made its debut in 1995, the popularity of fashion documentaries has only gained traction.  Within the past five years, a smattering of renowned brands, including Marc Jacobs, Louis Vuitton, and Valentino, as well as some fixtures in fashion like Anna Wintour and Diana Vreeland, have allowed cameras to capture their exclusive world of fashion through their respective documentaries.  More recently, James Franco, the former face of Gucci, steered his production company toward a collaboration with Gucci’s creative director Frida Giannini, creating the documentary entitled “The Director: An Evolution in Three Acts.”  The film, which debuted last spring at the Tribeca Film Festival, documented how a Gucci collection comes together.  Even retailers are following suit, with documentaries such as director Matthew Miele’s “Scatter My Ashes at Bergdorf Goodman,” which features the history of New York’s famous luxury department store, making their way to audiences.

While fashion documentaries have yet to garner the same level of commercial appeal as the level attained by certain political and/or topical documentaries, the fashion industry’s elite players seem eager and willing to demystify their creative process on-screen.  The value, while not necessarily directly realized through documentary distribution proceeds, may indirectly be realized through marketing.  In the same vein as fashion film shorts, full-length fashion documentaries blur the line between film and advertisement for the brands upon which the films are based.  (See Victoria Lee and Ted Max, Fashion Film Art Movement, Fashion and Apparel Law Blog, June 14, 2012).

Yet tension may exist between the desire of fashion houses and designers to promote their brands in a particular light, and documentary filmmakers’ desire to capture the provocative truth, whether positive or negative.  Even when the filmmaker has a vested interest in the brand’s success, it may have a particular point of view which is not in line with the brand’s marketing goals.  Therefore, when contemplating whether to pull back the curtain for the cameras, it’s important for a fashion brand to consider all the potential issues which may arise from the release of a fashion documentary featuring the brand and to preemptively address these potential issues during contract negotiations with the filmmaker involved with the project.

Certain contractual limitations on the filmmaker, such as those affecting access granted to production crews and approvals and controls over aspects of the documentary’s development and production, may be negotiated as precautionary measures for the brand to ensure the documentary serves its purpose as a marketing tool.  As “Bergdorf’s” director, Matthew Miele noted in a press release, while his film could come across as overly promotional, he noted that he retained control over its contents, working closely with Bergdorf Goodman during the post-production and editing process.

Based on the flurry of fashion documentaries slated to be released this year, including films profiling Stanley Marcus of Neiman Marcus, New York fashion icon Iris Apfel, and Miele’s look at Tiffany & Company, fashion documentaries appear to continue to serve a valuable marketing purpose.  No doubt with the right filmmakers attached to a fashion documentary project, a fashion brand can use the finished product to increase its presence as global powerhouse, both on- and off-screen.

Article by:

Fashion and Apparel Team

Of:

Sheppard, Mullin, Richter & Hampton LLP

How To Obtain Local Ranking For Cities Where Your Law Firm Does Not Have An Office

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If  you do not have physical presence in a specific city then it is unlikely that you will be able to obtain local map rankings within that city. If you are targeting a small neighboring city there is a greater chance that you can work your website optimization and business listing optimization to get your business listed in the local rankings. In our experience, we have seen businesses achieve such local rankings, but this typically happens when city populations are under 60K, within a 20-mile radius, or without strong law firm competitors.

If you are in a larger city like New York and are trying to target small neighboring cities, it is much harder to rank locally due to the large amount of competition and distance from the center of the main business cluster for your industry. That center is one of the top 10 foundational ranking factors as seen in the image from the 2013 Local Search Ranking Factors from Moz. However, for local businesses that want to rank for local cities there is a viable option.

Ranking in Cities Where You Do Not Have an Office

The strategy is to build a page on your law firm website and dedicate it to the city. You want to have your title tag, meta description, your page content and page headings contain the term or terms for want to rank for . If you are pursuing personal injury lawyer rankings for Cary, North Carolina, you would set your title to have Cary personal injury lawyer in it, and the same goes  for the rest of the previously mentioned locations. Do not stuff that keyword on the page multiple times in any one tag or area. Having that term once in the title, once in the description, once in a header tag, once in the description for the page content and in the content of the page two or three times is sufficient. Also consider incorporating the keyword into an image so the image file name mirrors the image Alt Tag. These are the basic foundations for your city-specific page.

What Content Should I Use On A Local Page?

You want to incorporate your business and the community into the content on that location page. Post pictures of client meetings, testimonials or case results that you have achieved in that city. If you have been in the local media for community service or cases you have worked, link to those sources. If you sponsor a school activity or are a member of a charity or non profit in that community, briefly mention the connection and link out. When you link out, make sure the links are going to relevant and related sites to your business and the location. Linking out to a legal nonprofit in that city that you are a member of or support is a great example, or even the city hall since that organization would have a physical location. These practices all tie in the location and make the page stronger for ranking in that location. Another good thing to do is link internally to your site. If you are trying to rank for Cary personal injury lawyer, then in the content on that local page you should link the words personal injury over to your main personal injury page. Also provide a link to your nearest office location – a link to your contact page or that office page which will have details such as hours of operation and directions.

Since your local page is basically a landing page where you will be driving potential clients, include a call to action. Try a form that they will fill out for more information or a phone number they can click on to call you, this way you are driving visitors to your physical office.

How To Build Links To A Local Page

The next important step, and often the hardest currently, is to build links back to this local page. One way to build links is to link from within your site to the location page. Examples of this are having phrases like “Cities we serve” or “Communities we help” on the page, then listing those locations and linking over to the specific local page. The next, and easiest, links to generate are to contact the organizations you are associated with for links. If you are part of the local chamber, you should already have a link from that location. If you sponsor a local kid’s sports team or another school related activity, see what it would take to get a link over to that page. The same goes for other non profits and any other association you are part of. Make sure you work with the organization to get a link to your location page.

The harder links to get are the ones that require considerable outreach and development. This is one reason many firms hire an agency to work out a strategy for obtaining these type of links. To obtain links from sites you are not connected to, but feel may be a relevant resource to, like a prominent legal blog, you have to organically build that relationship. Then, you have to offer to write high quality and attention-getting content so it will drive potential clients to your website from that website. Another wonderful technique is to leverage events. If you host or sponsor any local events then you have great opportunity to obtain local links and citations from those events.

Gone are the days that you could write quick, simple articles and post them anywhere. With all the Google updates in 2013 link outreach has taken a 360 and requires much more effort and skill to build a quality page and obtain quality links.

How To Use Social Media For Local Optimization

Finally, consider social media. While it may not directly help rank your page, it will increase your exposure and “signals” that Google monitors.  Consider participating in discussions and groups that are in the location you want to build visibility. Post content to these groups and genuinely contribute to discussions. This can help raise your recognition in that community. If there are no groups or discussions going on, consider starting them yourself if you have the time. Post quality content that is shareable. Particularly, shared posts on Google can rank quickly if done properly and tied to Google Authorship.

While you will not be able to get a map pin for a city you are not located in, you can take these actions to optimize a location page for that particular city and work on ranking it organically. This is the next best thing if you have no physical location. If you think you can pull enough clients from a specific city or if you were able to rank there, then you can consider opening a location there. Both are large undertakings. Creating a strategic local page is more simple and less costly, but getting those rankings without the local physical presence does make things difficult and can take considerable time.  This must be taken into consideration.

Article by:

Grant Brott

Of:

Consultwebs.com, Inc.

Employee’s Complaint About Union Officials Watching Porn is Deemed “Human Imperfection” But Not Grounds for Retaliation

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A union employee was suspended then terminated after being indicted – as part of an identity theft investigation by the prosecutor – which involved the public posting of names, salaries and Social Security numbers of the company’s managers during a previous strike. During her suspension, the employee claimed that she witnessed the union president and vice president looking at pornography during business hours, which she then reported to the union’s regional leaders. The employee also alleged that the union sabotaged her post-termination grievance process.

As a result, the employee sued the union under section 101 of the Labor-Management Reporting and Disclosure Act, alleging that she was retaliated against for raising a matter of union concern relating to the general interest of its members (i.e., her complaint about union officials watching porn during business hours). The Fourth Circuit found that the employee’s complaint did not rise to the level needed to meet the test and added that “human imperfection must be kept in some perspective.”

On Monday, the United States Supreme Court denied the employee’s bid for certiorari. (see Melissa H. Trail v. Local 2850 United Defense Workers of America et al., case number 13-332).

Article by:

Adam L. Bartrom

Of:

Barnes & Thornburg LLP

Registering Your Trademark with the Trademark Clearinghouse – Is Your House in Order?

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“It’s happening – the biggest change to the Internet since its inception” is how the president of ICANN’s Generic Domains Division has described the new gTLD Program being implemented by The Internet Corporation for Assigned Names and Numbers (ICANN), and rightfully so. The new program will result in the expansion of available generic Top-Level Domains (gTLDs), such as .COM, .NET or .ORG, from the list of 22 that we’ve all become familiar with through the years, to a list of possibly 1,400 generic Top-Level Domains.

On October 23, 2013, the first new gTLDs were “delegated”. This means they were introduced into the Internet’s “Root Zone”, the central authoritative database for the Internet. As a result, the domain name Registries, the organizations approved to operate these and other soon-to-be-delegated gTLDs, can execute the final processes required to make their domain names available to Internet users. ICANN claims that the purpose of this unprecedented expansion of domain name extensions is to enhance competition, innovation and choice in the Domain Name space, providing a wider variety of organizations, communities and brands new ways to communicate with their audiences. As available real estate in the “.com” territory has become increasingly scarce, it is hoped that the new gTLDs will provide additional space for entities and individuals to set up an online presence. While it is true that virtually every two or three letter combination seems to have already been registered in the “.com” Top-Level Domain, this explosion of new generic top-level domains also means big bucks for domain name registrars and additional costs for trademark owners who properly protect their marks.

While 4 new gTLDs were delegated in October, the delegation has been a rolling process, with new generic Top-Level Domains being released in November, December and January. Below are just a few of some the gTLDs that have successfully completed the process. The list will continue to be expanded as the measured rollout of the new gTLDs progresses over the coming years:

.equipment

.kitchen

.diamonds

.bike

.shoes

.technology

.enterprises

.gallery

.education

.graphics

.ceo

.ventures

As the new gTLD program is rolled out, many trademark owners are wisely looking for ways to protect their brands from being registered by third parties as domain names in the new gTLD space without their knowledge or consent. In view of the rapidly changing gTLD landscape, owners need to be aware of how to protect their marks, sooner rather than later.

What Does All This Mean for Brand Owners?

Over the past year, there has been significant discussion and concern in the legal community regarding the potential for trademark infringement by third parties seeking to register domain names that incorporate the brands of others under these newly released gTLDs.

In light of the potential for infringement, ICANN has established certain mechanisms for the new gTLD program in order to try and protect the rights of brand owners. The main tool for doing so is the Trademark Clearinghouse (TMCH), an entity created by ICANN with which trademark owners can register their marks in advance of the new gTLD launches.

Brand owners who register their trademarks with the TMCH can take advantage of a priority, or “sunrise”, period during which they are entitled to register domain names that are identical to their marks, before registration opens to the general public. In addition, the TMCH provides the brand owner with automatic notification of any third-party attempts to register domain names that are identical to their marks, enabling the mark owner to then take appropriate legal action. To be clear, this mechanism does not stop third-parties from registering domain names identical to marks registered with the TMCH, but does notify the brand owner, or its representative, of such registration. These devices provide brand owners with help against cyber squatters seeking to register infringing domain names under the new gTLDs.

Registration of a trademark with the TMCH is available for registered trademarks, marks protected by statute or treaty, or court-validated marks. Registration is also available for any other marks protectable under the new gTLD registry’s policies and that meet the eligibility requirements of the TMCH. Registration with the TMCH is encouraged for brand owners in order to combat infringement of their brands in cyberspace and registration costs currently are $150 per mark for a one-year term of registration, $435 for a three-year term, and $725 for a five-year term. Such registration with the TMCH does not include fees that will be charged by the new gTLD registrars to register domain names during the “sunrise” or general public registration periods.

The biggest change to the Internet since its inception is happening now…make sure your marks are protected!

Article by:

Nicole M. Meyer

Of:

Dickinson Wright PLLC

Bedside Manner: The Key to Landing and Retaining Clients

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Practicing law is very much a client-centric business and providing exceptional service is pivotal to a successful practice. Are you providing the service that your clients expect?

Survey after survey will tell you that the #1 reason why clients fire attorneys is “lack of responsiveness” or in general an overall lack of customer service. Correspondingly, the top reason clients hire lawyers is empathy and responsiveness. Keeping clients and potential clients happy is the key to not only maintaining, but growing your practice. The following are a few tips for ensuring that your bedside manner doesn’t impede your ability to attract and retain new clients.

client retention bedside manner law office management

Return Calls Promptly

The legal industry and in particular personal injury law is highly competitive. Speedy response time to new leads is the key to higher conversions (See our recent article about response time:http://www.rwlynchblog.com/the-key-to-converting-more-leads/). But your bedside manner doesn’t end there: lack of responsiveness is the most cited reason for firing a lawyer. Return client calls as soon as possible, even if it’s an email (or a call from a secretary or paralegal) that lets them know that their call is important to you and that you will respond as soon as possible.

Listen

Our most successful attorneys can attest to this advice: listen to everything a potential client has to say about his/her potential case. Yes, some potential clients can run off on tangents that are seemingly unrelated to a case. However, some of the best cases our clients say they’ve landed are cases that other attorneys turned away; simply because they didn’t take the time to listen and ask the right questions. Don’t lose potential clients because “you don’t have the time” to sort through all of the “riff-raff”. Giving your full attention and asking questions will allow you to uncover the important nuggets of information you may miss otherwise.

Don’t Use Legalese

Take the time to explain legal issues in a way your clients can easily understand them. These are complicated issues and clients are often scared and confused. Explaining issues in a clear and concise manner devoid of legal jargon will put your clients at ease.

Above All Empathize

Taking the time to care, explain the process and reassure clients will not only help you retain clients but will create a lasting impression that will ensure those clients will continue to refer new business your way.

Article by:

Brian Lynch

Of:

RW Lynch Company, Inc.

Hey Wait, What About North Carolina's Fancy New Quasi-Judicial Statute?

Poyner Spruill

 

In 2009, the North Carolina General Assembly adopted Senate Bill 44, an act that codified the case law regarding quasi-judicial land use proceedings, including the proper standards and procedures for judicial review. See N.C. Gen. Stat. § 160A-393. Quasi-judicial land use decisions include, among other things, decisions involving variances, special and conditional use permits, and appeals of administrative decisions. See N.C. Gen. Stat. § 160A-393(b)(3).  The adoption of this new statute took the effort of many accomplished land use attorneys and interested stakeholders.  In fact, discussions regarding the need for this legislation originated before my legal career even began. So, when I read a recent Court of Appeals decision involving the denial of a special use permit by a quasi-judicial body, I was befuddled as to why the opinion did not contain a single citation to G.S. § 160A-393.

In Blair Investments, LLC v. Roanoke Rapids City Council, et al. (filed December 17, 2013), the petitioner sought a special use permit to construct a cell phone tower.  After considering the evidence presented by the applicant, planning department and concerned neighbors, the Roanoke Rapids City Council denied the special use permit on the grounds that the proposed tower would “endanger the public or safety” and would “not be in harmony with the surrounding area.”  The Superior Court affirmed the Council’s decision.  On appeal, however, the Court of Appeals reversed the Council’s decision on the grounds that the applicant had met its burden of making a prima facie showing of entitlement to the special use permit and the testimony of the concerned neighbors were speculative opinions, unsupported by any documentary or testimonial evidence.  Therefore, the Court held the Council’s decision was not supported by substantial, competent, and material evidence and remanded the case with instructions that the special use permit be granted.  

To be clear, I take no issue with the Court’s ultimate decision in Blair.  The Court appropriately reviewed the record and made the correct determination based on the facts and evidence that were before the Council.  I also take no issue with the overall legal principles and case law cited by the Court in Blair.  I do find it perplexing, however, that in discussing the appeal procedure, scope of review and its ultimate disposition of the case, the Court cited to a number of cases decided prior to the adoption of G.S. § 160A-393, but did not cite to or discuss 160A-393 at all.  As already discussed, the purpose of adopting 160A-393 was to codify prior case law and establish the black letter law governing the review of quasi-judicial decisions.  Perhaps the failure to recognize or cite to 160A-393 was an oversight by the lawyers who argued the case or perhaps it simply slipped by the law clerks working on the opinion.  I can’t imagine, however, the statutory framework for reviewing quasi-judicial decisions was completely ignored by the Court intentionally.

Many might consider this article to be a technical assault on an otherwise good appellate opinion.  While I believe it to be a substantive omission, my true reason for writing this article is to hopefully ensure that this fancy new statute at least gets dropped in a future footnote. Too many people worked too hard for it not to.

Article by:

Chad W. Essick

Of:

Poyner Spruill LLP

New Online Privacy Policy Requirements Take Effect January 1, 2014

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California Online Privacy Protection Act (CalOPPA)

Owners of websites, online services or mobile applications (apps) that can be accessed or used by California residents should ensure their compliance with the new amendments to the California Online Privacy Protection Act of 2003 (CalOPPA) by the law’s January 1, 2014 effective date.  The borderless nature of the Internet makes this law applicable to almost every website or online service and mobile application.  Accordingly, companies should review and revise their online privacy policies to ensure compliance with the new law and avoid potentially significant penalties.

Previously, CalOPPA required the owner of any website or online service operated for commercial purposes (an “operator”) that collects California residents’ personally identifiable information (PII) to conspicuously post a privacy policy that met certain content requirements, including identifying the types of PII collected and the categories of third parties with whom that information is shared. The new law requires that companies subject to CalOPPA provide the following additional disclosures in their privacy policies.

  • How an operator responds to “do not track” signals from Internet browsers and any other mechanism that provides consumers a choice regarding the collection of PII about an individual consumer’s online activities over time and across third-party websites and online services.  A company may satisfy this requirement by revising its privacy policy to include the new disclosures or by providing a clear and conspicuous hyperlink to a webpage that contains a description of any program or protocol the company follows to provide consumers a choice about tracking, including the effects of the consumer’s choice.
  • An affected company must disclose to users whether third parties may collect PII about a user’s online activities over time and across different websites when a consumer uses the operator’s website or online service. However, an operator is not required to disclose the identities of such third parties.

The California law does not require that operators honor a user’s “do not track” signals. Instead, operators must only provide users with a disclosure about how the website or mobile app will respond to such mechanisms. “Do not track” mechanisms are typically small pieces of code, similar to cookies, that signal to websites or mobile apps that the user does not want his or her website or app activities tracked by the operator, including through analytics tools, advertising networks, and other types of data collection and tracking practices.  Further, the Privacy Enforcement and Protection Unit of the California Office of the Attorney General recently stated that the required disclosures should not be limited to tracking simply for online behavioral advertising purposes, but those disclosures must extend to any other purpose for which online behavioral data is collected by a business’s website (e.g., market research, website analytics, website operations, fraud detection and prevention, or security).

A violation of the law can result in a civil fine of up to $2,500 per incident. The California Attorney General maintains that each noncompliant mobile app download constitutes a single violation and that each download may trigger a fine.

Given that most company websites will have California visitors, companies should consider taking the following steps to ensure compliance with the CalOPPA amendments by January 1, 2014:

  • Identify the tracking mechanisms in place on your company’s websites and online services, including (a) the specific types of PII collected by the tracking mechanism and (b) whether users have the option to control whether and how the mechanisms are used and how the website responses responds to “do not track” signals by seeking input from those familiar with your website, including (i) technicians and developers who understand the mechanics of how the website operates, including how it responds to “do not track signals,” (ii) financial and marketing personnel who understand how user PII is monetized, and (iii) any other stakeholders who access or handle user PII.
  •  Review the practices of any third parties that have the ability to track users on your website. To draft the new disclosures, you will need to understand how those third parties track your users and whether they are capable of doing so before or after the users leave your service.
  • Incorporate the information identified above to modify your online privacy policy to include the required behavioral tracking disclosures.
  • Retain the prior version of the policy in your records, including the date on which each version was posted to the site. The new version should have an updated effective date to distinguish it from the previous version.

Expansion of California’s Data Breach Notification Requirements

Under another new law taking effect on January 1, 2014, California will expand its data breach notification requirements by adding new types of information to the definition of “personal information” under California Civil Code §§ 1798.29 and 1798.82. The new law requires notification if a California resident’s personal information is compromised, and, as with CalOPPA, the breach notification requirements apply regardless of the location of the organization that sustains the breach.  Therefore, to the extent that your business collects and retains California residents’ PII, then the amended California breach notification law would apply.

Previously, the California law required notification of a data breach in the event of the unauthorized access to or disclosure of an individual’s name, in combination with that individual’s (i) Social Security number, (ii) driver’s license or California ID number, (iii) account, credit or debit card number, together with a security or access code, (iv) medical information, or (v) health information, where either the name or the other piece of information was not encrypted. Under the new definition, “personal information” will also include “[a] user name or email address, in combination with a password or security question and answer that would permit access to an online account.”

Accordingly, if your business or organization collects this type of information, then it should consider undertaking the following proactive measures to reduce the risk and magnitude of a potential data breach:

  • Periodically and systematically delete nonessential personal information. By deleting obsolete PII and other sensitive information, businesses can significantly reduce the risk of a breach.  Retaining such obsolete legacy PII serves no business purpose, but only adds unnecessary exposure and potential liability.
  • Conduct a PII inventory and perform a risk assessment of your security measures.  Identify what PII is being collected by your organization, where it is retained, who has access to the PII and  the security measures to protect the PII.  Ensuring that sufficient protections are in place may not prevent every incident, but they can reduce the possibility of an incident occurring in the first place and limit the disruption to your business if there is a breach.
  • Limit the disclosure of PII to third parties only when necessary to provide services or products. You can be equally responsible for a data breach notification if the person or entity who experiences the data breach was a third party who received PII from you. Any vendor or third party with whom you share PII should contractually represent and warrant that they have in place certain standards for protecting that information and agree to indemnify your company for any loss that results from a breach.

 

Article by:

Of:

Vedder Price

Are You Ready for the Coming Explosion of Cybersquatting?

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The next wave of domain-name barbarians is gathering outside the gates. Here’s what you need to do now to keep your trademarks, and your e-commerce, safe.

Almost every business has had to deal with cybersquatters – pirates that launch web sites designed to divert customers by using domain names that mimic the business’s trademarks.

Until now, the war has focused primarily on domain names within the “.com” sphere. But the battlefront is about to expand – dramatically.

The international body that runs the Internet (called ICANN) has recently begun releasing new generic top-level domains (“gTLDs”). In addition to the familiar “.com,” this program makes it possible to set up a business name, a trademark, a geographic designation – virtually any word in any language – as a gTLD in its own right. Almost 2,000 applications for gTLDs were filed, and more than 1,000 will ultimately be granted. Because many of the new gTLDs will sell domain names to all comers without any attention to whether they are violative of someone else’s trademark rights, they will create a giant new arena in which domain name pirates can operate.

So what should you do now to protect your brands and your domain names?

1. Lock up the family jewels.

ICANN has mandated the creation of a Trade Mark Clearing House, in which owners can list their registered trademarks. It has also required that all newly-released gTLDs offer a 30-day “Sunrise” period in which owners of marks listed in the TMCH get first crack at registering them as domain names. In addition, during the Sunrise period and for sixty days thereafter, other parties that apply for those marks will be advised of the TMCH listing and, if they pursue their application, the owners of the TMCH-listed marks will be notified, giving them an opportunity to invoke various dispute-resolution procedures.

The Trademark Clearance House is now in operation, and it makes sense for brand owners to list at least their “core” trademarks there. These are the marks in which you have invested the most time, energy, and money; the ones most closely associated with your business; the ones you have already had to protect most often in the .com realm.

2. Plan now to make preemptive registrations in gTLDs of particular interest.

An important limitation of the Trade Mark Clearing House is that it protects only against domain names that are identical to your registered trademarks, not to common misspellings, typos, and so on. This leads to a second important step: being prepared to file preemptive domain name registrations for common variations of your brand.

Now is the time to identify specific gTLDs in which you will be especially interested in and to watch for their release dates. For instance, if you’re in the auto industry you will likely want to be active in such gTLDs as “.auto,” “.car,” and the like. As soon as the Sunrise period for one of your identified gTLDs opens, be ready to file immediately. This is an instance where the best defense is a vigorous offense.

Many brand owners were caught unawares years ago when the Internet burst upon the scene, and control of brand-related domain names became crucial. There’s no way to stop the next wave of cyberpiracy. But there’s also no reason not to be prepared for it.

Article by:

John C. Blattner

Of:

Dickinson Wright PLLC

Dark Sites Re: Secret Websites

DrinkerBiddle

 

In our modern media age, it sometimes feels as though everyone in the entire world has noticed the same thing at the same time.  So it is with the Deep Web and the darknes that lurk in the shadows – it was an obscure topic until few months ago, and now your grandparents have probably heard of them.  Once the type of thing that only geeks (like me!) would think and/or talk about, the topic has now made the front cover of Time Magazine (in a piece by legendary fantasy author and critic Lev Grossman).  It has also made national news (with the takedown of the infamous SIlk Road marketplace) and inserted itself into a far more noticeable place of prominence in our culture.

These hidden sites can be found through a collection of anonymous servers that enable a vivid underground of dissidents, hackers, criminals, law enforcement, drug runners and folks who seem like refugees from a James Bond movie.  All you need is a specialized tool like TOR, and (if you believe the stories) you can live a secret life online.  But should you care?  As a character says in one of my novels, “you may not be interested in the deep web, but the deep web is very interested in you.”

In the past when we talked with clients about the dark sites of the deep web, people really thought that it sounded like something out of a William Gibson story, like Chiba City in Neuromancer, or the Night Market in Nick Harkaway’s Angelmaker.   But now companies are suddenly finding themselves confronting deep web issues as never before, whether because someone has “doxed” their employees or executives (by releasing personally identifiable information on persistent sites that cannot be taken down), because their products are being counterfeited and distributed by online networks, because they are being defamed on chat boards that cannot be reached let alone turned off, because someone has used TOR to anonymously hack their passwords — the possibilities are endless, troubling, and happening now.  If you want to steal someone’s trade secrets and want to ensure that the transaction is untraceable, suddenly there are tools to accomplish exactly that.  If you’ve learned how to copy a product using a 3-D printer, you can distribute the plans.  If you want to cause trouble, you can hire someone directly to do that, pay them in bitcoins, and watch the damage from afar.

As a lawyer, it is impossible not to see how this is going to have a dramatic impact on IP, privacy, and nearly every other thing we do.  The Internet of Things is coming shortly (the FTC just held a workshop on the topic this week), and the facial recognition technologies and environmental advertising predicted in Minority Report are no longer futuristic fictions.  3-D and electronic printing promises to give ever smaller groups the ability to make things based on electronic schematics without access to heavy industry.  More and more information will be available about more people, and will be available to more people – and the fact that there are genuinely secure ways where those who are so inclined can use that data for criminal purposes should give everyone pause.

To be sure, all of this seems rather abstract, and it can sound like a tabloid scare tactic.  But there are some things that everyone can do to deal with the risks in their own lives.  First, engage in some data security hygiene: change your passwords regularly, don’t pass them out, don’t allow them to be easily engineered by people who know a few random facts about you.  Second, think about whether you are in a business where people will want to copy your products, will want to pretend to be you, will want to steal your information.  If you are that type of business, it is worth checking from time to time to see if you have been targeted.  And finally, as always, if is critical that everyone in this day and age try to stay abreast of what is happening in the world of tech – it is easy to assume that because you make donuts, or own a small clothing store, or manage a bank, or run a hedge fund, that you don’t need to know about the cutting edge developments coming down the pipe.  But you do.  The time when you could just stick to your knitting and ignore the tech world is past, and you need to assume that the tech world is very interested in you, indeed.

Article by:

Darren S. Cahr

Of:

Drinker Biddle & Reath LLP

Food and Drug Administration (FDA) Guidance for Industry and FDA Staff: Mobile Medical Applications

GT Law

 

On September 25, 2013, the Food and Drug Administration (the “FDA”) released final guidance on the regulatory requirements regarding the introduction of mobile medical applications into the marketplace (the “Final Guidance”).  The purpose of the Final Guidance and its Appendices is to assist manufacturers with determining if a product is a mobile medical app and if so the FDA’s expectations for that product.  This Alert summarizes some the key components of the Final Guidance.

I. Summary of the Guidance

This Final Guidance informs manufacturers, distributors and other entities on how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications).1   Some mobile applications may meet the definition of a medical device under section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), but because some may pose a lower risk to the public, FDA intends to exercise enforcement discretion.  A majority of mobile applications either do not meet the definition of the FD&C Act or are in a category where the FDA intends to exercise enforcement discretion.

The FDA intends to apply its regulatory oversight on those mobile applications that are medical devices and whose functionality could post a risk to a patient’s safety if the mobile application does not function appropriately.  The Final Guidance is intended to provide clarity and predictability for manufacturers of these mobile applications.

The Final Guidance provides lengthy definitions of the following terms:

  • Mobile Platform
  • Mobile Application
  • Mobile Medical Application
  • Regulated Medical Device
  • Mobile Medical App Manufacturer

The above-referenced definitions can be found in the full guidance.

II. Scope

The Final Guidance explains the FDA’s intent—to focus its oversight on a segment of mobile apps.

III. Regulatory Approach for Mobile Medical Apps

The FDA intends to apply its regulatory oversight to only those mobile apps that are (1) medical devices; and (2) whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. The FDA believes that if it fails to function as intended, this subset of mobile medical apps poses potential risks to the public health as currently regulated devices. The FDA strongly recommends that manufacturers who fall within the scope of this guidance follow the Quality System2  regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm. Manufacturers of mobile medical apps must meet the requirements associated with the applicable device classification.

A. Mobile medical apps: Subset of mobile apps that are the focus of the FDA’s regulatory oversight

The FDA currently intends to apply its regulatory oversight to only the subset of mobile apps.3   Of major importance, mobile apps can transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods. In spite of the transformation, FDA considers such mobile apps to be mobile medical apps.

The following are mobile apps that the FDA considers to be mobile medical apps that are subject to regulatory oversight:

  • Mobile apps that are an extension of one or more medical devices by connecting4  to such device(s) for purposes of controlling5  the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.
  • Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
  • Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.

B. Mobile Apps for which the FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act)

The Final Guidance illustrates the FDA’s exercise of enforcement discretion for mobile apps that: (i) Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; (ii) Provide patients with simple tools to organize and track their health information; (iii) Provide easy access to information related to patients’ health conditions or treatments; (iv) Help patients document, show, or communicate potential medical conditions to health care providers; (v) Automate simple tasks for health care providers; or (vi) Enable patients or providers to interact with Personal Health Record (“PHR”) or Electronic Health Record (“EHR”) systems.

It is important to note that some mobile apps listed above and below may be considered mobile medical apps, and others might not.

The following examples represent mobile apps for which the FDA intends to exercise enforcement discretion:

  • Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
  • Mobile apps that provide patients with simple tools to organize and track their health information.
  • Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).
  • Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.
  • Mobile apps that perform simple calculations routinely used in clinical practice.
  • Mobile apps that enable individuals to interact with PHR systems or EHR systems.

IV. Regulatory Requirements

Manufacturers of mobile medical apps are subject to the requirements described in the applicable device classification regulation.6

Our team will continue to provide you with updated information on various aspects of this Final Guidance.

1 While many have suggested that this guidance provides similar views on software, the Agency has taken a more formalized position on certain software requirements and the classification of such products.  For example, the FDA has previously clarified that when stand-alone software is used to analyze medical device data, it has traditionally been regulated as an accessory to a medical device or as medical device software.  Medical Devices; Medical Device Data Systems Final Rule (76 FR 8637) (Feb. 15, 2011).

2 See 21 CFR part 820.

3 See Appendix C.

4 To meet this criterion, the mobile medical apps need not be physically connected to the regulated medical device (i.e. the connection can be wired or wireless).

5 Controlling the intended use, function, modes, or energy source of the connected medical device.

6 Class I devices: General Controls, including:

  • Establishment registration, and Medical Device listing (21 CFR Part 807);
  • Quality System (QS) regulation (21 CFR Part 820);
  • Labeling requirements (21 CFR Part 801);
  • Medical Device Reporting (21 CFR Part 803);
  • Premarket notification (21 CFR Part 807);
  • Reporting Corrections and Removals (21 CFR Part 806); and
  • Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812).

Class II devices: General Controls (as described for Class I), Special Controls, and (for most Class II devices) Premarket Notification.

Class III devices: General Controls (as described for Class I), and Premarket Approval (21 CFR Part 814).

 

Article by:

Of:

Greenberg Traurig, LLP