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Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in response to the COVID-19 public health emergency CMS previously enacted extensive temporary COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. However, the Centers for Medicare and Medicaid Services (CMS) have now determined that various regulatory requirements must be restored in order to protect the health and safety of residents in long-term care facilities.Continue Reading NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices.  FDA stresses that during hurricanes and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. The guidance links to pages providing information on…

On March 23, 2017, New York State Attorney General Eric T. Schneiderman announced settlements with three mobile health application (app) development companies aimed at curbing deceptive marketing practices and inadequate privacy disclosures to consumers. The settlements – reached with Cardiio, Inc., Matis Ltd., and Runtastic GmbH, respectively – target health measurement apps that “purport to measure vital signs or other indicators of health using only a smartphone’s camera and sensors, without any need for an external device.”

The Office of Attorney General (OAG) expressed concern that growing consumer reliance on health-related apps “can be harmful” if the apps provide inaccurate or misleading results because they could cause consumers to potentially forgo necessary medical treatment, or conversely incur unnecessary treatment, in reliance on false assurances of health provided by such apps. In the settlements the OAG highlighted apparent issues it had identified with each of the developers’ apps, including:

  • That both Cardiio and Runtastic created a “net impression” via claims made on their websites and in app store listings that their respective heart rate monitor apps would accurately measure and monitor a consumer’s heart rate “without providing sufficient evidence substantiating” their claims regarding the app’s accuracy; and
  • That Matis made unsubstantiated claims regarding its fetal heartbeat app’s ability to monitor and play the sound of a fetal heartbeat by placing a smartphone on a woman’s stomach.

Continue Reading NY AG Announces Settlements with 3 Mobile-Health App Developers Over Privacy, Marketing Concerns

The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product.  FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).

In the Final Rule, FDA had amended the intended use regulations for drugs and devices at 21 C.F.R 201.128 (drugs) and 21 C.F.R. 801.4 (devices).  In announcing the delayed implementation, FDA attempted to clear up what it viewed as a misunderstanding about the Final Rule.  FDA emphasized that one of the revisions was meant to clarify that mere knowledge that the product was being prescribed or used by healthcare providers for an unapproved new use would not be sufficient on its own for FDA to find an unapproved new intended use for an approved or cleared drug or device.  In addition, the Final Rule was “intended to embody FDA’s longstanding position . . . that intended use can be based on ‘any relevant source of evidence,’ including a variety of direct and circumstantial evidence.”  The Final Rule used the phrase “the totality of the evidence” to accomplish this goal.Continue Reading FDA Delays Intended Use Regulations

On October 24, 2016, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a joint announcement of their plan to continue the Program for Parallel Review of Medical Devices.

The Program is a collaborative effort that is intended to reduce the time between FDA marketing approval and Medicare…