Category Archives: FDA

Five Creative and Necessary Ways of Getting Medical Apps Adopted

Posted on July 9, 2024 by

Medical apps will likely become an important healthcare tool. Once barriers such as reimbursement and regulatory issues are fully addressed there are many ways in which app developers and their commercial partners can penetrate the healthcare market. However, there are … Continue reading →

Posted in digital health, education, FDA, fitness, health insurance, healthcare economics, Healthcare IT, healthcare reform, medical apps, mHealth, smartphone apps, wireless health | Tagged , , , , , , , , , , , , , | 1 Comment

Five Ways the SCOTUS Decision on ACA Will Affect mHealth

Posted on June 28, 2024 by

The upholding of the majority and key points of the ACA by the Supreme Court was a monumental step in changing healthcare in the USA. It is reform. It is not the creative destruction that is necessary in … Continue reading →

Posted in FDA, health insurance, healthcare economics, Healthcare IT, healthcare reform, informatics, medical apps, mHealth, mobile health, politics, technology, wireless health | Tagged , , , , , , , , , | 3 Comments

Five Ways to get Congress Moving on Mobile Medical App Guidance

Posted on June 12, 2024 by

As many of the readers of this blog know by now, the FDA draft guidance on mobile medical apps was released on July 19, 2011. While there are those who believe that FDA involvement in the regulation of … Continue reading →

Posted in digital health, Election 2012, FDA, health insurance, healthcare reform, medical apps, mHealth, mobile health, politics, smartphone apps | Tagged , , , , , , , , | Leave a comment

Adoption of mHealth: Can we see the Forest through the Trees?

Posted on May 27, 2024 by

In previous posts, I have highlighted many drivers and stakeholders (patient advocates, healthcare providers, insurers, hospitals, Pharma, and others) as key to the success of the adoption of digital health technologies (. There was a recently proposed amendment to the … Continue reading →

Posted in digital health, Election 2012, FDA, health insurance, Healthcare IT, healthcare reform, media coverage, medical apps, medical devices, mHealth, mobile health, pharma, politics, technology, wireless health | Tagged , , , , , , , , , , | Leave a comment

Medical Apps Use Gaining Support by Providers

Posted on May 2, 2024 by

There have been some significant developments and noteworthy observations which are creating an atmosphere conducive to the institution of medical apps into widespread use. On the nursing front, a recent nursing survey which included almost 4000 nurses and nursing students … Continue reading →

Posted in mHealth, Healthcare IT, technology, smartphone apps, mobile health, informatics, wireless health, IT security, telehealth, FDA | Tagged , , , , , , , , , , , , , | 1 Comment

Can Digital Health Technologies make People Better Health Care Consumers?

Posted on April 17, 2024 by

By now, many have either heard Dr. Jon Cohen’s talk firsthand or read articles referring to it. Dr. Cohen, CMO of Quest Diagnostics was a speaker at the recent TEDMed conference where he commented on how poorly educated and motivated … Continue reading →

Posted in digital health, education, FDA, healthcare economics, Healthcare IT, healthcare reform, informatics, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | Leave a comment

Medical Device Recalls: Implications for Digital Health Technologies

Posted on April 12, 2024 by

Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication. A recall of those types of products often implies taking them off the market as … Continue reading →

Posted in digital health, FDA, healthcare reform, Implantable Defibrillators, medical devices, mobile health, technology, wireless health | Tagged , , , , , , , , | 5 Comments

Crowdsource-derived Data for Post-Market Surveillance of Drugs and Medical Devices

Posted on April 5, 2024 by

Recently,Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. It requires the FDA to issue a Unique Device Identifier rule by the end … Continue reading →

Posted in clinical trials, digital health, FDA, mobile health, wireless health | Tagged , , , , , , , | 1 Comment

Crowdsourced Clinical Studies: A New Paradigm in Health Care?

Posted on March 30, 2024 by

The Miriam-Webster defines crowdsourcing as: “the practice of obtaining participants, services, ideas, or content by soliciting contributions from a large group of people, especially via the Internet.” Clinical studies using patient recruitment and data collected via crowdsourcing is surely an … Continue reading →

Posted in clinical trials, digital health, education, FDA, healthcare reform, mobile health, pharma, technology, wireless health | Tagged , , , , , , , , | Leave a comment

Adoption of mHealth: Chicken or Egg?

Posted on March 21, 2024 by

There seems to be universal agreement among all stakeholders in health care that mHealth technologies will play a significant role in the future. The questions are how far into the future and how will they find their way to patients. … Continue reading →

Posted in clinical trials, digital health, education, FDA, Healthcare IT, healthcare reform, informatics, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , | Leave a comment