Tags Regulatory


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Why Have Low Safety Standards for Dental Anesthesia?

The idea that dental anesthesia is somehow different than anesthesia for any other type of procedure is just not true. So why are safety standards lower?

Denied Health Insurance? Don’t Fight It Alone

MyPatientRights.org channels patients' complaints through state's regulatory agencies, informing them about problems faced in their state's healthcare system.
prescription drugs medicine chest drug expiration

How Reliable are Drug Expiration Dates?

The process of setting drug expiration dates takes into account not just biochemistry, but also profits. How much could be saved by extending the dates just 10%?

How the FDA Regulates Drugs

The FDA drug approval process is not a straight path from evaluation to regulation. Instead, it follows a cyclical path of proposal, modification, and re-proposal until, finally, they reach a decision on the product and create regulations.

Lessons from the Granddaddy of Digital Health: The WellDoc Story

The story of WellDoc contains important lessons for digital health entrepreneurs who hope to create a sustainable business.
woman sleeping with airing

Airing’s Inventor Responds to Readers’ Questions and Concerns

Pat Salber (@docweighsin) interviews Stephen Marsh, CEO of Airing, about TDWI readers' questions and concerns regarding the company's micro-CPAP product.
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The Urgency to Increase Security Against Cyberattacks

The first-ever government warning that a medical device was vulnerable to hacking was for an insulin pump that could deliver a fatal dose of the medication.
Validic: The Digital Health Connector Model

Catching Up with Validic, the Digital Health Connector [Video]

Validic enables the transfer of patient-generated digital data from a variety of devices so that developers can incorporate that data into their solutions.
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Will Your Medical App Require Regulation?

Legal expert Michael H. Cohen explains whether or not a mobile medical app (MMA) needs to be regulated

Eko’s Digital Stethoscope Lets You See Heart Sounds

The technology of existing stethoscopes has been around for >200 years. Eko Core's digital technology brings this key diagnostic tool into the 21st century.
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Nano Silver, Ebola, & Dr. Rima’s Truth

Rima Laibow's Natural Solutions Foundation has recently been issued a warning letter from the FDA about their claims that Nano Silver can cure Ebola

Nathan Cortez JD on FDA Regulation of Mobile Health Technologies

One of the hottest topics in mHealth is FDA Regulation - Listen to this TDWI podcast as Nathan Cortez, JD, a leading expert in field, addresses the issues.