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New Hampshire Amends Patient Privacy Law Following IMS v. Sorrell Decision

May 11, 2012 — In the wake of the June 2011 U.S. Supreme Court decision in IMS v. Sorrell, which ... read more

CMS: Sunshine Act Data Collection Will Be Delayed Until 2013

May 7, 2012 — The Centers for Medicare & Medicaid Services (CMS) stated on the CMS blog that following its ... read more

Guest Column: Heavy Meddle by Peter Pitts

May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for ... read more

Proposed OTC Drug Distribution Would Expand Patient Access to “Rx” Drugs

April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve ... read more

PDUFA V Bills Moving Forward Without Specific Marketing Provisions

April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User ... read more

CHC and TAC Comments Object to “Dual Modality” Risk Communication in DTC TV Ads

April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office ... read more

ACRE Study Finds Medical Journal Discussion of Academic/Industry Relationships Unbalanced

April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in ... read more

FDA Draft Guidance on DTC TV Ads Raises Important Questions

By John Kamp April 9, 2012 – The only thing really clear about the new guidance on pre-review of the ... read more

FTC to Industry: Adopt Consumer Privacy Best Practices Now

March 28, 2012 – Industry members needing another reason to join the fray of companies participating in the Digital Advertising ... read more

Call for Industry Comments: Proposed FDA Study on “Corrective” DTC TV Advertising

March 26, 2012 – Note to Industry Leaders The Coalition for Healthcare Communication needs your input on a study FDA ... read more

New Video Highlights Advances in CME Conflicts of Interest Policies

March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – ... read more

FDA Draft Guidance on DTC TV Ads Identifies Campaigns Subject to 45-day Pre-Review Process

March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls ... read more

DAA’s Self-regulatory Ad Program to Protect Consumers Online Is Praised by White House, DOC and FTC

 Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer ... read more

Coalition Calls for Substantial Revisions to Sunshine Act Proposed Rules

Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care ... read more

Digital Health Coalition Issues Guiding Principles and Best Practices to Help Lead Way on Robust Use of Social Media by Medicine Companies

Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, ... read more

Digital Advertising Alliance Launches Consumer Education Campaign

Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform ... read more

MMM: CME Video Addresses Conflict of Interest

Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but ... read more

Does Novo Nordisk’s Victoza + Paula Deen = Recipe for Success?

Jan. 20, 2012 – Common sense should tell people that some of celebrity chef Paula Deen’s infamously unhealthy dishes – ... read more

Sunshine or Rain?

By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication Jan. 17, 2012 – The Affordable Care Act ... read more

MMM Features Kamp’s Call for Industry Leadership on Off-label, Online Communications

 Jan. 6, 2012 — This article, written by Coalition for Healthcare Communication Executive Director John Kamp, was featured in the ... read more

FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media

Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to ... read more

FDA Approval Report Contains Good News for Patients and Industry

  By John Kamp, Executive Director, Coalition for Healthcare Communication – Nov. 7, 2011 – Until the research labs and ... read more

RPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge

Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, ... read more

Par Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech

Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment ... read more

Kamp on the Sunshine Act: Collaboration Key to Patient Care

Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care ... read more

Experts Weigh In on Implications of Sorrell Decision

Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in ... read more

Academic Detailing and Health Plan Communications: Is the Playing Field Level?

By Kenneth P. Berkowitz, Esq. July 21, 2011 — Why does the government fail to apply current regulatory requirements and ... read more

Sorrell v. IMS: What Marketing Professionals Need to Know

By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the ... read more

Kamp Column: Industry Must Embrace Internet and Social Media or Become Irrelevant in Many Health Conversations

By John Kamp, Executive Director, Coalition for Healthcare Communication June 29, 2011 — Yesterday I had the pleasure of moderating ... read more

PhRMA Survey Shows That Physicians Value Industry Communication

March 31, 2011 — At a time when interaction between biopharmaceutical companies and physicians is under increased scrutiny, a recent ... read more

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Kerry/McCain Commercial Privacy Bill of Rights Has No “Do Not Track” Provision

April 14, 2011 – “The Commercial Privacy Bill of Rights Act of 2011,” introduced Tuesday by Sen. John Kerry (D-Mass.) and Sen. John McCain (R-Ariz.), would establish a framework to protect consumer information online but stops short of calling for a “Do Not Track” provision that has been the hallmark of other recently proposed legislation.

“When the bill comes to the Senate floor, there will be amendments, and someone may offer an amendment on [Do Not Track],” Kerry said at an April 12 press conference to announce the bill. However, he indicated that such a provision was excluded because it affected industry support for the legislation and added that he believes “the robustness of the opt-out” set forth in the bill “will answer concerns about Do Not Track.”

The Coalition for Healthcare Communication opposes mandatory Do Not Track provisions. The Coalition believes that consumer privacy and robust Internet commerce is better served by self-regulation enabling easy consumer opt-outs of unwanted tracking and marketing. “The Coalition and the 4As have led the development and implementation of a voluntary program – www.AboutAds.info – which is building a system to help Web users understand when they are being tracked online and allows them to opt out as needed,” said John Kamp, Coalition executive director. “We’re delighted the draft bill recognizes this effort.”

In crafting the bill (see Commercial Privacy Bill of Rights Text), which would put in place rules to regulate the collection, use and dissemination of consumer data and guide the Federal Trade Commission (FTC) in enforcing such protections, Kerry and McCain sought to strike a balance between consumer protections and the value of online advertising, Kerry said at the press conference.

“Many consumers enjoy the ability to receive targeted advertisements or visit Web sites that are free because they are completely ad-supported, but consumers must have control over how their data is used,” Kerry said. “We believe consumers and businesses will benefit from having a framework” for that communication and information exchange.

McCain noted in a statement that the bill “does not allow for the collection and sharing of private data by businesses that have no relationship to the consumer for purposes other than advertising and marketing. It is this practice that American consumers reject as an unreasonable invasion of privacy.”

Kerry also made clear that business interests were considered as well as consumer interests. “We produced this legislation with great sensitivity to the marketplace and to the economy,” he said. “Plenty of companies collect data and use it with high ethical standards and they use that data to innovate and tailor the services that they deliver to the clients they serve,” he added. 

Specifically, the bill sets forth the following consumer privacy rights:

  • The right to security and accountability: collectors of information must implement security measures to protect the information they collect and maintain;
  • The right to notice, consent, access and correction of information; and
  • The right to data minimization, constraints on distribution, and data integrity.

The Safe Harbor provision defined in the bill would allow the FTC to approve nongovernmental organizations to oversee voluntary safe harbor programs that would have to achieve protections at least as rigorous as those enumerated in the bill. Incentives for enrolling in a safe harbor program would include allowing safe harbor participants to design or customize procedures for compliance and to be exempt from some of the bill’s requirements.

“If we have to have legislation in this area,” Kamp said, “the Kerry/McCain bill’s safe harbor provision at least would allow our self-regulatory program to move forward.”

Recognizing that many companies are making significant investments in consumer privacy protections even in the absence of new laws, Kerry said that forging ahead in a collaborative manner shows that industry “knows that [consumer privacy protection] doesn’t just make business sense – it’s the right thing to do.”