HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health Insurance Portability and Accountability Act (HIPAA) rules addressing mobile health app developers.  The letter, written in November but made public last week, from  HHS Secretary Sylvia Mathews Burwell responds to concerns outlined in an earlier request written by DeFazio on behalf of the trade group ACT | The App Association regarding enforcement of HIPAA.   Continue reading

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23andMe Advances Its Goal of Creating Commercialized Database from Consumer Genetic Testing

On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their own genetic history.  This furthers 23andMe’s plan to become a repository for human genetic makeup and to turn data gathered from its $99 saliva tests sold to consumers into a large information sharing deals with drug companies.  However, the creation and use of this database raises potential privacy concerns.

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Next Round of HIPAA Audits to Begin “Expeditiously”

During a media roundtable held this week, the Director of the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) Jocelyn Samuels provided additional information regarding the long awaited next round of audits for compliance with the Health Insurance Portability and Accountability Act (HIPAA).  Specifically, she said that audits will be implemented “expeditiously” and will be governed by new audit guidelines. Continue reading

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FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and Budget (OMB) for review and clearance.

According to the notice published in the Federal Register on January 13, 2015, prescription drug advertising regulations require that broadcast (TV or radio) advertisements present the product’s major risks, also referred to as the “major statement.” The FDA expressed concern that, as currently implemented in the DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. However, at the same time, the FDA also recognizes that there is a conflicting concern that DTC TV ads do not include adequate risk information or leave out important information.

In order to evaluate these conflicting concerns, the FDA proposes a study intended to investigate the impact of limiting the risks presented in DTC prescription drug TV advertisements to those that are serious and actionable, including a disclosure to alert consumers that there are other product risks that are not disclosed in the advertisement.  The FDA hypothesizes that, relative to the inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks.

The notice describes the study design in additional detail and provides responses to those comments from the industry in response to the FDA’s previous request for comments in February 2014 regarding DTC advertisements.

All comments are due by February 12, 2015 and should be identified with: (1) the OMB control number “0910-New” (2) the title “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads)” and (3) “Docket No. FDA-2014-N-0168.” Comments should be faxed to the Office of Information and Regulatory Affairs, OMG, Attn: FDA Desk Officer, (202) 395-7285, or e-mailed to oira_submission@omb.eop.gov.

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Obama Advocates Federal Breach Reporting Law

On January 12, 2015, President Obama delivered a speech at the Federal Trade Commission during which he set forth several proposals, including the Personal Data Notification and Protection Act (the “Act”).  The Act would institute a federal data breach reporting framework by requiring businesses that hold consumer data to issue alerts to those consumers within thirty days of a data breach.

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Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug, device, biological, or medical supply that provides a payment or transfer of value to an advanced practice registered nurse (APRN) practicing in the state to submit the information required by the Department on a quarterly basis.  The first report covering the period January 1, 2015 to March 31, 2015 is due July 1, 2015.  All reports must be submitted via email to DCP.DrugManufacturers@ct.gov.

Significantly, payments and transfers of value will not be reported to the Department in a consolidated form.  Rather, an Expenditure Disclosure Form must be completed and submitted for each APRN to whom the manufacturer provides a reportable payment or transfer of value, potentially creating a significant administrative burden for manufacturers and the Department each quarter.  The following information must be provided on the form: name of manufacturer; first and last name of recipient; medical license number of recipient; Connecticut controlled substance registration (if applicable); date the expenditure was incurred; value/amount of expenditure; nature of the expenditure; purpose of the expenditure; FMV payment description; up to 5 prescribed products to which the expenditure relates, including product type (e.g., pharmaceutical, biologic, medical device, combination product) and product name; name and email address of person completing the form.


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FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015.   This guidance is a first for the FDA and comes as a product of negotiations with the medical device industry over Medical Device User Fee Amendments of 2012 (MDUFA III).  The lists of guidance is broken into an A-List (which the FDA intends to publish) and a B-List (which the FDA will publish “as resources permit”).  There is a third list of historically released guidance – from 2005, 1995 and 1985 – that are “subject to focused retrospective review.”  Some of the key A-List items are:

  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
  • Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions

 Important B-List items include:

  • Transfer of Ownership of a Premarket Notification: Questions & Answers
  • Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing)
  • 3D Printing (Technical)

Comments may be submitted on any or all of the lists.  There was little reaction to the guidance from Capitol Hill.  However, the guidance was released the same week the newly-seated 114th Congress began its discussions to repeal the medical device tax and prepared to release draft proposals and legislation under the 21st Century Cures Initiative – which is related to the “discovery, development and delivery of treatment and cures.”

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