HL Chronicle of Data Protection : Privacy Lawyers & Attorneys : Hogan Lovells Law Firm : Data Security, E-Commerce & Technology

The Federal Communications Commission and the Food and Drug Administration jointly announced this week an upcoming public forum to discuss the review process for “Life-Saving Wireless Medical Technology.” The joint public forum is scheduled for July 26-27, 2010 and written comments in advance of the meeting are due June 25, 2010.

The FCC and FDA share joint regulatory authority over wireless-enabled medical devices, most notably those relying upon commercial broadband wireless networks to relay patient information back to providers. As described in the FCC news release, “[t]he joint public meeting . . . reflects a commitment by the two agencies to work even more closely to ensure the safety and reliability of [these] devices while increasing their availability to consumers and health care providers. This collaboration is a critical step in the development and approval of new wireless medical devices . . . .” The two agencies expressed a desire to develop a collaborative, streamlined process for review of new devices.

The accompanying Public Notice included a list of questions on which the agencies are seeking written comments in advance of the public forum. These topics include:

• Data integrity and reliability issues arising from the use of allocated spectrum, the use of unlicensed devices, and the use of commercial networks and applications, and needs, uses, and risks for ‘medical-grade’ wireless technology and communications.

• Medical device and system security issues including inadvertent and intentional intrusion.

• View on current FDA and FCC regulatory requirements, including the relationship between FDA approval/clearance and FCC certification of applications, and post market and compliance requirements

The request also solicited comments on additional topics appropriate for inclusion in the forum.

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The Federal Communications Commission released its long-awaited National Broadband Plan today, providing an aggressive roadmap for advancing affordable broadband deployment and adoption; stimulating economic growth; and boosting the nation's capabilities in education, healthcare, homeland security, and other areas.  The Plan also appears to confirm that the FCC is looking to take an expanded role in privacy-related consumer protection issues.

In the Plan, the FCC discusses a number of broadband privacy and data security issues focused on the protection of and consumer control over personal information.  For example, the FCC states 

 

[t]he collection, aggregation and analysis of personal information are common threads among, and enablers of, many application-related innovations...

and the Plan notes the value of services such as customized suggestions for movie rentals or books and more targeted and relevant advertising.  It cautions, however

many users are increasingly concerned about their lack of control over sensitive personal data.

The FCC then remarks:  

Innovation will suffer if a lack of trust exists between users and the entities with which they interact over the Internet.  Policies therefore must reflect consumers’ desire to protect sensitive data and to control dissemination and use of what has become essentially their “digital identity.”  Ensuring customer control of personal data and digital profiles can help address privacy concerns and foster innovation.

The FCC also makes several broadband privacy and data security recommendations in the Plan, including:

• Encouraging Congress and the Federal Trade Commission (as well as the FCC) to clarify the relationship between users and their online profiles, including disclosure and consent requirements and data collection, sharing, storage, safeguarding, and accountability responsibilities;

• Suggesting that Congress consider helping spur the development of trusted "identity providers" that can help consumers maximize the privacy and security of their data;

• Having the FTC and FCC jointly develop principles to require that customers provide informed consent before broadband service providers share certain information with third parties (including account and usage information and other personally identifiable information); and

• Prompting the federal government to put additional resources into combating identity theft and fraud and enhancing consumer online security.

In addition, the Plan includes several privacy and data security recommendations in the smart grid and cybersecurity areas, including a recommendation that states require utilities to "provide consumers access to, and control of, their own digital energy information, including real-time information from smart meters and historical consumption, price and bill data over the Internet."  If states fail to do so within 18 months, the Plan recommends that Congress consider national legislation.

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The Federal Communications Commission released a Public Notice this week seeking further comment on numerous privacy issues as part of its National Broadband Plan proceeding.  Based on questions raised in a recent Center for Democracy & Technology filing, some of the broad issues that the Notice seeks comment on include:

• Consumer expectations of privacy, and how to meet those expectations as new technologies are deployed;
• Building Privacy by Design;
• Concerns surrounding the collection, use, and storage of transactional data; and
• The regulation of third-party applications.

The FCC, which is working to complete the Plan and submit it to Congress by March 17, has thus far not focused extensively on how to protect consumer privacy and personal information in the broadband ecosystem.  This Notice, however, indicates that the FCC may be planning to highlight a number of privacy-related consumer protection issues in the Plan.  Moreover, depending in part on the comments received in response to the Notice, it could also open the door to future privacy and data protection proceedings at the FCC.

Comments are due on January 22, 2010, just over a week after the Commission issued the Notice.

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