HHS Issues Guidance on HIPAA and Cloud Providers

The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs).

In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business associates under HIPAA, and are therefore subject to HIPAA’s requirements.  HHS expressly rejects the idea that CSPs are analogous to “conduits” (such as internet service providers) that provide transmission-only services.  Rather, HHS explains that CSPs store and maintain PHI and thus have ongoing and routine access.

This guidance will be instructive to manufacturers of medical devices that connect to and store data on the cloud.

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District Court Dismisses State Law Unfair Competition Claim as Preempted by Federal Copyright and Patent Law

The Northern District of Texas recently held that federal copyright and patent laws preempted a state law unfair competition claim involving rival medical device companies.  The decision reflects that a preemption analysis does not consider whether the facts support actual protection by copyright or patent law.  Rather, the copyright preemption analysis looks to, among other things, whether the works “fall within the subject matter of copyright.”  The patent preemption analysis looks to whether the state law is used to protect “functional aspects” of a product.  Referencing Supreme Court jurisprudence, the decision reminds that “state regulation of intellectual property must yield where it clashes with the balance struck by Congress.”

A copy of the court decision is available here.  The decision is currently on appeal at the Fifth Circuit. Continue Reading

France Boosts Its eHealth Initiatives

The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health.  The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity to improve health monitoring, prevention and research.  In addition, according to past surveys, a vast majority of French people view eHealth initiatives as a promising tool for modernizing their healthcare system, but consider France to be lagging behind in this sector. Continue Reading

Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review

As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and 10 concerning firms’ communications about such uses.  FDA’s notice also follows the release of a set of joint principles endorsed by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), known as Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers (“Principles”).  Although it is unclear whether or when FDA might provide guidance on its views regarding permissible truthful communications regarding off-label uses of approved or cleared medical products, statements and guidance from industry associations, such as the Principles proposed by and PhRMA and BIO, provide valuable insight to device manufacturers about the topics that are under review.  The industry statements may also assist the FDA in formulating new guidelines that take into account First Amendment principles outlined in recent court decisions and settlements. Continue Reading

FDA Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps

Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential areas for further discussion with the agency. FDA is accepting comments on the HCT/P draft guidances until September 27, 2016. Continue Reading

CFDA Releases New Administrative Measures on Medical Device Recalls for Comment

The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning Commission) released in 2011 (Current Rules).  Comments on the Proposed Rules are due on September 30, 2016. Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical device has important consequences and often depends on a complex and very facts-based assessment.  The CJEU’s ruling may help to clarify how to apply the existing regulatory criteria on the qualification and classification of software as a medical device.

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FDA to hold Public Hearing on Communicating Information about Off-Label Conditions of Use

Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”

In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.” FDA provides some general discussion regarding the need to balance the potential benefits of allowing greater communication of relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products, against the potential risks, the need for controls, and the need to preserve incentives for supplemental approvals.  Continue Reading

CFDA Proposes Priority Review Pathway for Certain “Breakthrough” Medical Devices

The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules).  This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which was released in August 2015.  Document No. 44 is a blueprint for the reform of drug and medical device review procedures and an effort to ensure that CFDA has an efficient procedure for approving medical devices that fill unmet medical needs.  Continue Reading

Federal Circuit Rules Device Patent Claims Not Limited by Specification Description, Not Invalid for Lack of Written Description

Earlier this month in ScriptPro LLC v. Innovation Associates, Inc., the Federal Circuit overturned a district court’s grant of summary judgment based on a lack of written description under 35 U.S.C. § 112. The device patent at issue, ScriptPro’s U.S. Patent No. 6,910,601 (“the’601 patent”), “is directed to a ‘collating unit’ used with a control center and an automatic dispensing system … to store prescription containers after a medication has been dispensed into containers.”  The district court determined that the “patent’s specification limits the invention to a collating unit that sorts and stores prescription containers by patient-identifying information and slot availability,” and that, therefore, the claims, which contained no such limitation, were invalid for lack of written description.

The Federal Circuit concluded that the specification does not limit the claimed invention to use of a collating unit that sorts and stores prescription containers by patient-identifying information. In reaching this conclusion, the Federal Circuit found several aspects of the intrinsic evidence persuasive. Continue Reading