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FCC Slams Serial Robocaller With $120 Million Proposed Fine for “Spoofing” Numbers

We all get them. Repeated marketing calls to our mobile and home phones with the incoming phone number altered to make it appear that it’s a local call, when in fact, the call is from a robo-scammer using IP technology to “spoof” the phone number. As it turns out, there’s a federal law that makes such spoofing illegal, the Truth in Caller ID Act of 2009 (“TICIDA”), and in its first enforcement action under TICIDA, the FCC hit an alleged serial robocaller, Adrian Abramovich and his companies (together, Abramovich) with a whopping $120 million Notice of Apparent Liability for allegedly originating nearly 100 million such calls.

The Commission also issued a Citation and Order to Abramovich for alleged violations of the Telephone Consumer Protection Act (“TCPA”) for making unauthorized prerecorded telemarketing calls to emergency phone lines, wireless phones and residential phones without obtaining the required prior express written consent from the called party. While TICIDA allows the Commission to directly fine first-time violators through its NAL authority, which it did here, in TCPA FCC enforcement actions involving entities and individuals that do not hold Commission authorizations, the Commission must first issue a citation, and then can only proceed with a fine if the recipient repeats the violation. That still leaves Abramovich open to potentially monumental TCPA class action exposure. The Citation and Order also notified Abromovich that he had violated the federal wire fraud statute by transmitting or causing to be transmitted, by means of wire, misleading or false statements with the intent to perpetrate a fraud.

According to the Commission, Abramovich ran a scheme where his spoofed calls appeared to originate from local numbers and offered, via a pre-recorded message, holiday vacations and cruises claiming to be associated with well-known American travel and hospitality companies. The pre-recorded messages would prompt customers to “press 1” to secure their reservation. Once a customer pressed “1”, the customer was transferred to a call center where live operators pushed vacation packages typically involving timeshare presentations, that were not affiliated with the well-known brands used in the recorded messages. The Commission characterized Abramovich’s schemes as “one of the largest – and most dangerous – illegal robocalling campaigns the Commission has ever investigated.” According to the Commission, in addition to defrauding consumers, the robocalling campaign also caused disruptions to an emergency medical paging service, which provides paging services for emergency room doctors, nurses, emergency medical technicians, and other first responders.

While significant in absolute terms, the $120 million proposed fine, according to the Commission, was significantly below the penalty that could have been proposed in the NAL. Rather than fine the statutory maximum of $11,052 for each spoofing violation, or three times that amount for each day of a continuing violation, the Commission calculated the base forfeiture amount at $1,000 per unlawful spoofed call, since this was the first time the Commission used its TICIDA forfeiture authority.

Mr. Abromovitz now has an opportunity to respond to both the NAL and Citation. Stopping illegal robocalling has been a key priority for Chairman Pai, and no doubt the Commission is expecting that the threat of huge monetary forfeiture penalties against the industry will provide a powerful incentive for roboscammers to look for other ways to make a buck. Given the Commission’s struggle with fashioning tools to go after serial robocallers that do not have the effect of increasing TCPA exposure for established companies engaging in legitimate customer communications, we do not expect the Commission to back down from its proposed penalty, and expect this to be the start of a new enforcement initiative using TICIDA and its direct penalty provisions.

This post was written byRebecca E. Jacobs, Martin L. Stern and Douglas G. Bonner of Womble Carlyle Sandridge & Rice, PLLC.

The FCC Responds to Comcast’s Negative Option

On Tuesday, October 11, the Federal Communications Commission (“FCC” or “Commission”) announced the release of an Order and Consent Decree with cable behemoth Comcast Corporation (“Comcast”) in which the company agreed to pay US$2.3M to settle an FCC investigation into whether Comcast employed negative option billing to wrongfully charge for services and equipment customers never authorized. The settlement also requires Comcast—by some accounts the largest cable company in the country with 22.3M subscribers—to adopt a sweeping, highly detailed five-year compliance plan designed to force the company to obtain customers’ affirmative informed consent prior to adding charges to their bills. According to the FCC’s press release, the settlement amount is the largest civil penalty the agency has ever assessed against a cable operator.

What is Negative Option Billing and How Does the FCC Regulate It?

“Negative option billing” is a practice similar to “cramming” in the telecommunications context, wherein a company places unauthorized charges on a consumer’s bill, requiring subscribers to pay for services or equipment they did not affirmatively request. In addition to the obvious nuisance of unknowingly paying for unauthorized services and equipment, the FCC’s action is also aimed at protecting consumers from “spend[ing] significant time and effort in seeking redress for any unwanted service or equipment, which is often manifested in long telephone wait times, unreturned phone calls from customer service, unmet promises of refunds, and hours of effort wasted while pursuing corrections.” For these and other consumer protection reasons, negative option billing is illegal; it violates both Section 623(f) of the Communications Act of 1934, as amended (the Act), and Section 76.981(a) of the Commission’s rules. Specifically, 47 U.S.C. § 543(f) explicitly prohibits negative billing options, noting also that a failure to refuse an offer is not the equivalent of accepting the offer.

As the FCC clarified in a 2011 Declaratory Ruling, while a customer does not have to know and recite specific names of equipment or service in the course of ordering those products, the cable operator must have “adequately explained and identified” the products in order for a subscriber to “knowingly accept[] the offered services and equipment by affirmative statements or actions.”

Section 76.981(b) explains that the negative billing option does not prevent a cable operator from making certain changes without consumer consent, such as modifying the mix of channels offered in a certain tier, or increasing the rate of a particular tier (unless more substantive changes are made, such as adding a tier, which then increases the price of service).

The FCC appears to have found only one violation of the negative option billing prohibition previously, and in that context, the Commission used its discretion to refrain from imposing a penalty. More than 20 years ago, in 1995, the Commission acted on a complaint and investigated Monmouth Cablevision for allegations that the company—which had previously rented remote controls to their subscribers—violated FCC rules when it removed the leasing fee on subscriber bills and instead included a $5 sale price for the remotes. In that case, the Commission explained that, while “in a literal sense, this is the same equipment that the customer previously rented, we cannot find that these customers affirmatively requested to purchase these remotes rather than renting them.” The Commission went on to explain that “changing the way in which existing service and equipment is offered, e.g., from leasing to selling,” did, in fact, violate the Commission’s negative option billing prohibition. However, due to the “de minimis difference between the $ 5.00 purchase price and the total rental price” and because of the “large number of regulatory requirements that became effective on September 1, 1993, and the associated compliance difficulties,” the then Cable Services Bureau chose not to impose a penalty. Because state governments have concurrent jurisdiction over negative billing practices, cable companies have faced court action for these and similar allegations for decades.

The FCC Investigation

Based on “numerous” consumer complaints, the FCC’s Enforcement Bureau opened an investigation in December of 2014 into whether Comcast engaged in negative option billing. In the course of its investigation, the FCC determined that customers were billed for “unordered services or products, such as premium channels, set-top boxes, or digital video recorders (DVRs).” Beyond not authorizing these products, in some cases the FCC claims that subscribers specifically declined additional services or upgrades, only to be billed anyway. In fact, the Order—which is part of the settlement but generally not subject to the non-government party’s review prior to release—details numerous complainants that claim to have been given the runaround by Comcast customer service representatives, with one customer (Subscriber A) claiming that, after three hours on the phone and multiple transfers, she was ultimately transferred to a fax machine. Another complainant (Subscriber B) asserted that he determined Comcast had wrongfully billed him for approximately 18 months for an extra cable box he never ordered, and that he spent another year calling to request (unsuccessfully) that the company remove the charge.

The Settlement

The Order and Consent Decree are striking in terms of the level of transparency exhibited throughout. Unlike most FCC settlements, in which facts and legal arguments are closely guarded and held confidential, this Order reads more like a Notice of Apparent Liability for Forfeiture, where the FCC explains the underlying facts and legal theories in substantially more detail. Especially noteworthy here, is that unlike majority of the other settlements released by the FCC’s Enforcement Bureau since Travis LeBlanc took the helm, neither the Order nor the Consent Decree include a statement admitting liability. Rather than an admission of liability by Comcast, the Consent Decree includes a lengthy discussion of the perspectives of both Comcast and the Commission. Besides arguing that most of the services were authorized and that unauthorized services inadvertently added to consumer bills were removed, Comcast—represented by FCC regular and first Enforcement Bureau Chief David Solomon—argued that the Commission itself “has cautioned against an expansive application of the Negative Option Billing Laws, stating that a broad reading of the rule could lead to harmful consequences.” Moreover, Comcast asserted that “the Negative Option Billing Laws are not per se prohibitions, but instead are targeted only at affirmatively deceptive conduct on the part of cable operators, and Commission enforcement requires a demonstrated pattern of violation,” rather than an erroneous charge “occasioned by employee error” that does not involve deceit or intent. For its part, the Commission asserted that it believes “the Customer Complaints and other facts adduced during the Investigation are evidence of violations of Section 623(f) of the Act and Section 76.981 of the Commission’s Rules.”

Moreover, the settlement requires that Comcast be required to comply with the terms of the Order and Consent Decree for an uncharacteristically long term—i.e., five years instead of the three years the Bureau has normally insisted upon.

In addition to the US$2.3M civil penalty, Comcast must implement a highly detailed compliance plan. Although in many instances, Comcast is given until July 2017 to create and implement requisite processes, the level of detail applied to the cable company’s alleged transgressions is similar to that found in certain cramming and slamming settlements. In those instances, however, the Commission is usually acting against less sophisticated targets with decidedly fewer resources that cannot retain compliance personnel with the expertise to design, develop, and implement their own expansive compliance plans. Among other things, and as explained in five pages of detail in the Consent Decree, the company is required to:

obtain customers’ affirmative informed consent prior to charging them for new services or equipment; send customers an order confirmation, separate from any other bill, that clearly and conspicuously describes newly added services and equipment and their associated charges; offer mechanisms to customers that, at no cost, enable them to block the addition of new services or equipment to their accounts; implement a detailed program for redressing disputed charges in a standardized and expedient fashion; limit adverse actions (such as referring an account to collections or suspending service) while a disputed charge is being investigated; designate a senior corporate manager as a compliance officer; and implement a training program to ensure customer service personnel resolve customer complaints about unauthorized charges.

Going forward, it appears that the Commission will have a substantial amount of insight into the way the company conducts its business vis-à-vis its customer service responsibilities, in the form of annual reports and extended document retention requirements.

Lessons from the Settlement

Over the past two and a half years, it has become more apparent that the FCC is willing to apply old rules in new ways, and to continue to be an aggressive enforcer of the rules in general, but particularly when it comes to protecting consumers. Although the Commission has issued Enforcement Advisories in the past, alerting companies that it is on the lookout for noncompliance in certain areas, this US$2M+ action is proof that regulatees should not wait for FCC warnings before ensuring they are compliant with the rules. Companies should take heed and adopt a proactive approach to understanding the rules applicable to them based on their business operations.

ARTICLE BY Koyulyn K. Miller of Squire Patton Boggs (US) LLP

FCC’s Enforcement Bureau Commends PayPal for Modifying its User Agreement

We previously advised that the FCC’s Enforcement Bureau, in an unusual move, on June 11 published a letter it sent to PayPal warning that PayPal’s proposed changes to its User Agreement that contained robocall contact provisions might violate the TCPA.

These proposed revisions conveyed user consent for PayPal to contact its users via “autodialed or prerecorded calls and text messages … at any telephone number provided … or otherwise obtained” to notify consumers about their accounts, to troubleshoot problems, resolve disputes, collect debts, and poll for opinions, among other things. The Bureau’s letter highlighted concerns with the broad consent specified for the receipt of autodialed or prerecorded telemarketing messages and the apparent lack of notice as to a consumer’s right to refuse to provide consent to receive these types of calls.

On June 29, prior to the revisions coming into effect, PayPal posted a notice on its blog stating: “In sending our customers a notice about upcoming changes to our User Agreement we used language that did not clearly communicate how we intend to contact them.” PayPal clarified that it would modify its User Agreement to specify the circumstances under which it would make robocalls to its users, including for important non-marketing reasons relating to misuse of an account, as well as to specify that continued use of PayPal products and services would not require users to consent to receive robocalls.

The FCC’s Enforcement Bureau immediately put out a statement commending PayPal for its decision to modify its proposed contact language, noting that these changes to the User Agreement represented “significant and welcome improvements.” The Bureau’s very public actions on this matter signal to businesses everywhere of the need to review existing “consent to contact” policies. Certainly the FCC’s yet to be released Declaratory Ruling on TCPA matters that was voted on during a contentious FCC Open Meeting on June 18 may also invite that opportunity.

ARTICLE BY Laura H. Phillips of Drinker Biddle & Reath LLP

FCC Chairman Proposes New TCPA Rules

The FCC is ready to rule on long-standing petitions seeking clarifications of the Telephone Consumer Protection Act and related FCC regulations. On May 27, 2015, FCC Chairman Tom Wheeler circulated a proposed regulatory ruling to fellow commissioners, which would address issues raised in more than 20 pending petitions. The fact sheet summarizing the chairman’s proposal foreshadows bad news for legitimate businesses using automatic telephone dialing technology.

The fact sheet lumps scammer calls like those from perky “Rachel” of the mysterious and ambiguous “Cardholder Services” with those from legitimate businesses. The fact sheet cites the 214,000 consumer complaints about robocalls. No breakdown is given as to how many of these complaints involved con artists and how many related to businesses calling, for example, to collect debt. The tone of the fact sheet provides no comfort. Its preamble states the plan is to “close loopholes and strengthen consumer protections.”

The FCC will vote on the new proposal during its Open Commission Meeting scheduled for June 18, 2015. In the meantime, companies using automatic telephone dialing technology should plan to take action to comply with whatever comes from the FCC. There will be no notice and comment period and whatever passes at the Open Commission Meeting will become effective immediately upon release.

New Provisions

If Chairman Wheeler’s proposals are adopted without changes, the new rules will provide:

Wireless and wired telephone consumers will have the right to revoke their consent to receive calls and text messages sent from autodialers in any reasonable way at any time. Many courts have concluded that consumers have a right to revoke consent. Some have said that revocation must be in writing. Some have said consent, once given, cannot be taken back. If this proposal passes, all courts likely will hold that consent may be revoked in any reasonable way at any time. This rule will have consequences beyond TCPA exposure. For example, it is likely to increase the cost of credit because creditors and debt collectors will have to employ more people to manually dial debtors who have failed to meet their obligations and utter the words, “Stop calling me!”
To prevent “inheriting” consent for unwanted calls from a previous subscriber, callers will be required to stop calling reassigned wireless and wired telephone numbers after a single request. It is not clear from the fact sheet what the individual on the other end of the line must say to notify the caller that they are not the person they seek to reach.
The TCPA currently prohibits the use of automatic telephone dialing systems to call wireless phones and to leave prerecorded telemarketing messages on landlines without consent. The current definition of an “automatic telephone dialing system” under the TCPA is “equipment which has the capacity to (A) to store or produce telephone numbers to be called, using a random or sequential number generator; and (B) to dial such numbers.” A 2003 FCC ruling focused on the use of the word “capacity” in the definition and broadly extended the definition to cover autodialers used to dial specific numbers. This ruling has resulted in inconsistent court decisions over whether a dialer must have a present capacity to so dial or whether a future capacity is sufficient for to trigger TCPA coverage. The new proposal appears to attempt to resolve the ambiguity by amending the definition of an “automatic telephone dialing system” to mean “any technology with the capacity to dial random or sequential numbers.” That is not much help. The industry needs an answer on the present versus future capacity issue. As it stands now, a court could conclude that a smartphone is an automatic telephone dialing system. The tone of the fact sheet suggests that this problem is not going to be solved in a way that is favorable to industry.

Existing Provisions Under TCPA

Chairman Wheeler’s proposal also provides for some very limited and specific exceptions for “urgent circumstances,” which may include free calls or text messages to wireless devices that alert consumers of potential fraud or that remind them of urgent medication refills. Consumers will still have an opportunity to opt-out of these types of calls and texts.

The new proposal will also leave many of the existing provisions of the TCPA intact:
The FTC will continue to administer the National Do-Not-Call Registry to prevent unwanted telemarketing calls
Wireless and home phone subscribers can continue to prevent telemarketing robocalls made without prior written consent
Autodialed and prerecorded telemarketing and information calls and text messages to mobile phones will still require prior consent
Political calls will still be subject to restrictions on prerecorded, artificial voice, and autodialed calls to wireless phones, but will continue to not be subject to the National Do-Not-Call Registry because they do not contain telephone solicitations as defined by FCC regulations
Consumers will still have a private right of action for violations of the TCPA along with statutory penalties

Implications

If adopted, the new regulations may significantly restrict the use of autodialing technologies by business. However, the devil will be in the details. Organizations should review the owners’ manual that came with their dialer. What can it actually do? In other words, what is its present and future capacity? Have those answers ready so you can act when the FCC rules. Companies should also have proper processes and systems in place to meet the consumer opt-out requirements of any new regulations. Policies should address steps to take when a called party claims that the number called no longer belongs to your intended recipient.

One thing is certain about these new rules, they will not stop scammers who use spoofed caller IDs and originate calls from outside of the United States and, therefore, outside of the jurisdiction of the FCC and/or FTC. They will just make to harder and more expensive for legitimate businesses to reach their customers.

ARTICLE BY Chanley T. Howell, Michael C. Lueder & Steven Millendorf of Foley & Lardner LLP

Junk Fax Act Compliance: One Week Left to Request a Waiver for Non-Compliance

Thursday, April 30, 2015, marks the last day a business can request a retroactive waiver for failing to comply with certain fax advertising requirements promulgated by theFederal Communications Commission (FCC). The scope of these requirements was clarified on October 30, 2014, when the FCC issued an Order (2014 Order) under the Junk Fax Prevention Act of 2005 (Junk Fax Act). The 2014 Order confirms that senders of all advertising faxes must include information that allows recipients to opt out of receiving future faxes from that sender.

The 2014 Order clarifies certain aspects of the FCC’s 2006 Order under the Junk Fax Act (the Junk Fax Order). Among other requirements, the Junk Fax Order established the requirement that the sender of an advertising fax provide notice and contact information that allows a recipient to “opt out” of any future fax advertising transmissions.

Following the FCC’s publication of the Junk Fax Order, some businesses interpreted the opt-out requirements as not applying to advertising faxes sent with the recipient’s prior express permission (based on footnote 154 in the Junk Fax Order). The 2014 Order provided a six-month period for senders to comply with the opt-out requirements of the Junk Fax Order for faxes sent with the recipient’s prior express permission and to request retroactive relief for failing to comply. The six-month period ends on April 30, 2015. Without a waiver, the FCC noted that “any past or future failure to comply could subject entities to enforcement sanctions, including potential fines and forfeitures, and to private litigation.”

ARTICLE BY

Julia Jacobson

Matthew R. Turnell

McDermott Will & Emery

FCC to Issue Net Neutrality Rules–Federal Communications Commission

In February, Federal Communications Commission Chairman Tom Wheelerwill circulate a draft order regarding Net Neutrality to his four fellow commissioners. The Net Neutrality rules will govern whether Internet service providers (ISPs), such as Comcast or Verizon, can block access to websites or give preferential treatment to traffic from websites that pay for such treatment. To sustain the rules, the commission may change the regulatory classification of broadband service, subjecting it to rules, known as Title II, that apply to traditional phone service, rather than the less restrictive Title I rules that currently cover broadband. 47 U.S.C. §§ 153–621.

This will be the FCC’s third attempt at imposing Net Neutrality obligations. The U. S. Circuit Court reversed the commission’s first two attempts, finding that the rules were inconsistent with the classification of broadband as a Title I service. Comcast Corp. v. FCC, 600 F.3d 642 (D.C. Cir. 2010); Verizon v. FCC, 740 F.3d 623 (D.C. Cir. 2014). In the most recent opinion, the court struck down two rules, one prohibiting ISPs from blocking access to websites and one prohibiting them from unreasonably discriminating against traffic from websites or applications.

In response, the FCC published a proposal to reinstate the rules with small changes to address the Court’s concerns. The proposal was roundly criticized by Net Neutrality proponents, because it did not flatly outlaw discrimination. President Obama weighed in with a statement in favor of Net Neutrality rules. Recently, Chairman Wheeler has strongly indicated that the new proposal will reclassify broadband as a Title II service and include a rule banning unreasonable discrimination. The Chairman plans to circulate a draft order to the other commissioners, giving them a chance to comment on the draft and vote on the proposal at the FCC’s open meeting on February 26.

The effect of the rules is uncertain. Rules banning discrimination have been in place for only three of the 12 years since Net Neutrality was first proposed. Even though discrimination was allowed for more than nine years of that time, ISPs have not been able to convince content providers to pay for priority treatment. The new rules may outlaw activities that the ISPs do not have the market power to engage in anyway. But the rules will give content providers comfort that the ISPs will not be able to charge them for priority service in the future.

The bigger (and more uncertain) impact will arise if the FCC reclassifies broadband as a Title II service. If this happens, the Commission will probably forbear from applying most sections of Title II to broadband. But the FCC’s authority to forbear from applying the statute in these circumstances is uncertain. Such a decision will be challenged on each section of Title II and the myriad of regulations under it. Litigation will last for years. If the FCC’s decision to forbear is reversed, the ISPs may be subject to some very onerous Title II regulations, such as obligations to resell their services, obligations to sell out of tariffs, and price restrictions. The outcome could be a messy hodge-podge of regulations that apply to some services and providers but not others.

ARTICLE BY

FCC: The New Data Security Sheriff In Town

Data security seems to make headlines nearly every week, but last Friday, a new player entered the ring. The Federal Communications Commission (“FCC”) took its first foray into the regulation of data security, an area that has been dominated by the Federal Trade Commission. In its 3-2 vote, the FCC did not tread lightly – it assessed a $10 million fine on two telecommunications companies for failing to adequately safeguard customers’ personal information.

The companies, TerraCom, Inc. and YourTel America, Inc., provide telecommunications services to qualifying low-income consumers for a reduced charge. The FCC found that the companies collected the names, addresses, Social Security numbers, driver’s licenses, and other personal information of over 300,000 consumers. The data was stored on Internet servers without password protection or encryption, allowing public access to the data through Internet search engines. This, the FCC found, exposed consumers to “an unacceptable risk of identity theft.”

The FCC charged the companies with violation of Section 222(a) of the Communications Act, which it interpreted to impose a duty on telecommunications carriers to protect customers’ “private information that customers have an interest in protecting from public exposure,” whether for economic or personal reasons. Additionally, the companies were charged with violation of Section 201(b), which requires carriers to treat such information in a “just and reasonable” manner.

The companies were determined to have violated Sections 201(b) and 222(a) by failing to employ “even the most basic and readily available technologies and securities features.” The companies further violated Section 201(b), the FCC found, by misrepresenting in their privacy policies and statements on their websites that they employ reasonable and updated security measures, and by failing to notify all of the affected customers of the data breach.

Commissioners Ajit Pai and Michael O’Rielly dissented, arguing that, among other things, the FCC had not before interpreted the Communications Act to impose an enforceable duty to employ data security measures and notify customers in the event of a breach. Though now that the FCC has so-interpreted the Act, we can expect the FCC to keep its eye on data security.

The FCC made clear that protection of consumer information is “a fundamental obligation of all telecommunications carriers.” Friday’s decision also makes clear that the FCC will enforce notification duties in the event of a breach, and will look closely at carriers’ privacy policies and online statements regarding data security.

ARTICLE BY

David A Munkittrick

Proskauer Rose LLP

Proposed Health Information Technology Strategy Aims to Promote Innovation

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with theOffice of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”

This report, entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework”, was mandated by Section 618 of the Food and Drug Administration and Innovation Act, and establishes a proposed blueprint for the regulation of health IT. The FDA, ONC and FCC (the Agencies) noted that risk and controls on such risk should focus on health IT functionality, and proposed a flexible system for categorizing health IT and evaluating the risks and need for regulation for each category.

The Agencies set out four key priority areas: (1) promote the use of quality management principles, (2) identify, develop, and adopt standards and best practices, (3) leverage conformity assessment tools, and (4) create an environment of learning and continual improvement.

The Agencies are seeking public comment on the specific principles, standards, practices, and tools that would be appropriate as part of this regulatory framework. In addition, the Agencies propose establishing a new Health IT Safety Center that would allow reporting of health IT-related safety events that could then be disseminated to the health IT community.

The Agencies also divided health IT into three broad functionality-based groups: (1) administrative, (2) health management, and (3) medical device. The Agencies noted that health IT with administrative functionality, such as admissions, billing and claims processing, scheduling, and population health management pose limited or no risk to the patient, and as a result no additional oversight is proposed.

Health IT with health management functionality, such as health information and data exchange, data capture and encounter documentation, provider order entry, clinical decision support, and medication management, would be subject the regulatory framework proposed in the report. In addition, the FDA stated that a product with health management functionality that meets the statutory definition of a medical device would not be subject to additional oversight by the FDA.

The report had a spotlight on clinical decision support (CDS), which provides health care providers and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care. The report concluded that, for the most part, CDS does not replace clinicians’ judgment, but rather assists clinicians in making timely, informed, higher quality decisions. These functionalities are categorized as health management IT, and the report believes most CDS falls into this category.

However, certain CDS software – those that are medical devices and present higher risks – warrant the FDA’s continued focus and oversight. Medical device CDS includes computer aided detection/diagnostic software, remote display or notification of real-time alarms from bedside monitors, radiation treatment planning, robotic surgical planning and control, and electrocardiography analytical software.

The FDA intends to focus its oversight on health IT with medical device functionality, such as described above with respect to medical device CDS. The Agencies believe that this type of functionality poses the greatest risk to patient safety, and therefore would be the subject of FDA oversight. The report recommends that the FDA provide greater clarity related to medical device regulation involving health IT, including: (1) the distinction between wellness and disease-related claims, (2) medical device accessories, (3) medical device CDS software, (4) medical device software modules, and (5) mobile medical apps.

The comment period remains open through July 7, 2014, and therefore the report’s recommendations may change based on comments received by the Agencies. In the meantime, companies in the clinical software and mobile medical apps industry should follow the final guidance recently published by the FDA with respect to regulation of their products.

In the meantime, health information technology companies should follow the final guidance recently published by the FDA with respect to regulation of their products.

Article By:

Stephanie L. Zeppa

Lauren Lewis

Of:

Sheppard, Mullin, Richter & Hampton LLP

Gaga for Gigabit: The FCC (Federal Communications Commission) Liberates 100 MHz of Spectrum for Unlicensed Wi-Fi

On April 1, the FCC took steps to remedy a small but growing annoyance of modern life: poor Wi-Fi connectivity. Removing restrictions that had been in place to protect the mobile satellite service uplinks of Globalstar, and by unanimous vote, the FCC’s First Report and Order on U-NII will free devices for both (i) outdoor operations; and (ii) operation at higher power levels in the 5.15 – 5.25 GHz band (also called the U-NII-1 band).¹The Report and Order also requires manufacturers to take steps to prevent unauthorized software changes to equipment in the U-NII bands, as well as to impose measures protecting weather and other radar systems in the band.

The practical impact of these rule changes is difficult to overstate. By removing the operating restrictions in the U-NII-1 band, the FCC essentially doubled the amount of unlicensed spectrum in the 5 GHz band available to consumers. In the near future, use of this spectrum will help to alleviate congestion on existing Wi-Fi networks, especially outdoor “hotspots” typically used at large public places like airports, stadiums, hotels and convention centers. Two less-obvious, longer-term benefits also are worth watching.

First, the new IEEE 802.11ac standard for Wi-Fi was finalized in January 2014. This next generation Wi-Fi standard is capable of delivering vast increases in raw throughput capacity to end-users, often approaching the holy grail of transfer speeds: 1 gigabit. To achieve those speeds, wide channels of operation are required – channels that simply were not available to Wi-Fi devices. Now that the U-NII-1 band has been unleashed for Wi-Fi usage, there should be little impediment to the near-term rollout of 802.11ac compatible devices.

This new standard will offer marked improvements in download speeds and streaming quality, and be a boon to consumers who increasingly rely on mobile devices for bandwidth intensive applications such as HD video. Unsurprisingly, cable operators in particular are excited by the possibilities of this technology; on the day the Report and Order was released, Comcast Chief Technology Officer Tony Werner authored a lengthy blog post touting the possibilities of Comcast offering Gigabit Wi-Fi to its customers utilizing the U-NII-1 band.^[2]

Second, in addition to the untempered enthusiasm of the MSOs, wireless carriers also have a stake in this unlicensed spectrum. Specifically, as use of licensed mobile spectrum continues to expand exponentially, the wireless carriers will increasingly encourage wireless offloading as a means of addressing congestion and capacity issues on macro cellular networks. For example, Cisco Systems estimates that 45% of global mobile data traffic was offloaded onto the fixed network through Wi-Fi or small cells in 2013^.[3]

This transformation of 100 MHz of spectrum in the U-NII-1 band marks one part of a renewed focus on consumer broadband at the FCC. In addition to unlicensed Wi-Fi, the FCC is also in the middle of a proceeding – covered in an earlier FCC Law Blog post^[4]– to streamline rules for wireless infrastructure. Taken together with the FCC’s release earlier this week of auction rules for 65 MHz of AWS-3 spectrum later this year, it becomes clear that although it is early yet, the Wheeler Commission is gaga for broadband.

_{[1] U-NII is the acronym for “Unlicensed National Information Infrastructure devices”, unintentional radiators which facilitate broadband access and wireless local area networking, including Wi-Fi. A copy of the First Report and Order is available here.}

_{[2] See Tony Werner’s blog post here.}

_{[3] See Global Mobile Data Traffic Forecast Update, 2013-2018.}

_{[4] See Sleeper “Small” Cells: The Battle Over The FCC’s Wireless Infrastructure Proceeding.}

Article By:

Douglas A. Svor

Dave Thomas

Of:

Sheppard, Mullin, Richter & Hampton LLP

High Court Tosses Out Indecency Cases, Finds FCC Didn’t Give Proper Notice to Broadcasters

Michelle Cohen of Ifrah Law recently had an article, High Court Tosses Out Indecency Cases, Finds FCC Didn’t Give Proper Notice to Broadcasters, featured in The National Law Review:

On June 21, 2012, in FCC v. Fox Television Stations Inc., the U.S. Supreme Court struck down the Federal Communications Commission’s effort to apply its indecency standard to brief broadcasts of nudity and “fleeting expletives.” But the Court relied not on the First Amendment’s free-speech guarantees but rather on the Fifth Amendment’s due process clause.

The Court held that Fox and ABC were not given fair advance notice that their broadcasts, which occurred prior to the announcement of the new indecency policy, were covered. This retroactive application violated their due process rights.

Broadcasters were hoping for a much broader First Amendment ruling that would have permanently hamstrung efforts by the agency to police indecency on the air. Instead, although a $1.4 million fine against ABC and its affiliates and a declaration by the FCC that Fox could be fined as well were both overturned, the agency remains free to create new indecency policies and case law under 18 USC 1464, which bans the broadcast of any” obscene, indecent, or profane language.”

In ABC’s case, the transgression was showing a seven-second shot of an actress’s buttocks and the side of her breast on NYPD Blue in 2003, and in Fox’s case, it was some isolated indecent words uttered by Cher and Nicole Richie on awards shows.

Prior FCC policy stressed the difference between isolated indecent material (which was not punished) and repeated broadcasts (which resulted in enforcement action). The Court held that Fox and ABC did not have sufficient notice that these brief moments, which occurred before the new policy went into effect, could be targeted.

The U.S. government tried to argue that a 1960 statement by the FCC gave ABC notice that broadcasting a nude body part could be contrary to the prohibition on indecency. The Supreme Court said “no dice,” as FCC had in other, later decisions declined to find brief moments of nudity actionable. If the FCC is going to fine ABC and its affiliates $1.24 million, it had better provide clear, fair notice of its indecency policies.

Since the case doesn’t affect the enforceability of the FCC’s current standard, as applied to current (rather than past) broadcasts, however, broadcasters still live in fear of the possibility of big fines levied against them for a couple of obscenities or a few seconds of nudity.

We agree with longtime public interest advocate Andrew Schwartzman, who said of this ruling, “The decision quite correctly faults the FCC for its failure to give effective guidance to broadcasters. It is, however, unfortunate that the justices ducked the core 1st Amendment issues. The resulting uncertainty will continue to chill artistic expression.”

The courts can certainly review challenges to the FCC’s indecency standards, and related issues will continue to come before the courts, including the issue of whether the current indecency standard violates the First Amendment rights of broadcasters and whether any changes the FCC may make will survive First Amendment scrutiny.

Meanwhile, with this case resolved, the FCC can finally move forward with a backlog of indecency complaints pending before it. FCC Commissioner Robert M. McDowell said in response to the Supreme Court ruling that there are now nearly 1.5 million such complaints, involving 9,700 television broadcasts, and that “as a matter of good governance, it is now time for the FCC to get back to work so that we can process the backlog of pending indecency complaints.”

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