You’re developing a health app for mobile devices and you want to know which federal laws apply. Check out this interactive tool.
WHAT ARE THE LAWS? Does your mobile app collect, create, or share consumer information? Does it diagnose or treat a disease or health condition? Then this tool will help you figure out which – and it may be more than one – federal laws apply. It’s not meant to be legal advice about all of your compliance obligations, but it will give you a snapshot of a few important laws and regulations from three federal agencies.
Health Insurance Portability and Accountability Act (HIPAA)
Federal Food, Drug, and Cosmetic Act (FD&C Act)
Federal Trade Commission Act (FTC Act)
FTC’s Health Breach Notification Rule
WHICH LAWS APPLY TO YOUR MOBILE HEALTH APP? Go here.
The Federal Trade Commission (FTC) has released a new interactive tool on its website, with help from the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA), to help health app developers to determine whether certain r
From taxicabs to hotels, some of the oldest areas of economic activity in the world have been upended by mobile apps like Uber and Airbnb. Healthcare, on the other hand, another industry that traces its roots to ancient times, has remained
Cardiac rehabilitation patients who used a health app lost more weight following a heart attack than those who went through cardiac rehabilitation without one, according to a small Mayo Clinic studythat will be presented at the American College of Cardiology's 65th Annual Scientific Session in Chicago next week.
D-Eye, a smartphone-based retinal imaging system, has raised $1.68 million (1.5 euros) from Innogest, Invitalia Ventures, Giuseppe e Annamaria Cottino Foundation, and Si14.
The product was first conceived in Padua, Italy, by Dr. Andrea Russo, an ophthalmologist, when he was examining his patients. D-Eye CEO Rick Sill told MobiHealthNews that Russo got the idea when he was with a patient one day and his phone rang.
“He looked at the smartphone and said ‘I wonder if it would be possible to use the smartphone as a digital ophthalmoscope because now I could actually capture images using the smartphone. Then I’d be able to transmit those images to other doctors to view if they were so interested,’” Sill explained in an interview. “He went out and bought himself a 3D printer and started cranking out ideas for attaching a lens on top of a smartphone that would allow him to do just that, to image the retina.”
Suivre son poids avec une balance intelligente, contrôler sa glycémie avec une appli... Les outils de santé mobile font partie de notre quotidien e
Via LEO INNOVATION LAB FRANCE
Lionel Reichardt / le Pharmageek's insight:
Il existe actuellement environ 100 000 applications santé disponibles dans le monde sur l’App Store et Google Play, dont plus de 1000 en français. Rien d’étonnant à ce que 70 % des mobinautes santé déclarent ne pas avoir trouvé l’appli qui leur convient ! Et quand ils pensent l’avoir trouvée, 46 % la désinstallent après le premier usage, et 90 % après le 5ème lancement pour cause de déception…
New Deloitte report highlights the four critical dimensions of effective mhealth that must be aligned in order for mhealth to reach its full potential.
The promise of mobile health (mHealth), the use of mobile devices to support the practice of medicine and public health, is profound but, as yet, unrealized, according to a new report from Deloitte Consulting.The report, “The Four Dimensions of Effective mHealth: People, Places, Payment and Purpose” discusses how mHealth strategies are not “one-size-fits-all.” and leveraging mHealth makes it possible to provide a more versatile and personalized approach to health care.
Des applications de « téléconseil médical » commencent à fleurir et proposent à leurs utilisateurs de payer pour des conseils dispensés à distance par des médecins. Enquête sur ces services à l'éthique douteuse.
Alors que toutes les marques veulent leur application, de plus en plus d'utilisateurs de smartphones se concentrent sur seulement quelques applis et suppriment rapidement les autres. Pour proposer des applis vraiment utiles les marques doivent travailler avec les concepteurs et ce sur la durée.
mPower, a Parkinson’s disease (PD) iPhone app developed by Sage Bionetworks and a team of neurologists at the University of Rochester Medical Center (URMC), marked the first year of its release by being highlighted in Apple Inc.’s “Loop You In” special product launch event on March 21, 2016.sagelogoCoinciding with the event, Sage Bionetworks, a Seattle-based nonprofit biomedical research organization, released an updated version of its mPower (Mobile Parkinson’s Observatory for Worldwide, Evidence-based Research) app with an improved user interface and enhanced functionality based on user feedback. Sage also announced that mPower will be the first app incorporated into a new Apple platform called CareKit, making the mPower app an even more valuable tool in keeping Parkinson’s patients better informed about their symptoms and care status, and as a data collecting medium for clinical studies should the user wish to participate.
Via Alex Butler
To improve the completeness of reporting of mobile health (mHealth) interventions, the WHO mHealth Technical Evidence Review Group developed the mHealth evidence reporting and assessment (mERA) checklist. The development process for mERA consisted of convening an expert group to recommend an appropriate approach, convening a global expert review panel for checklist development, and pilot testing the checklist. The guiding principle for the development of these criteria was to identify a minimum set of information needed to define what the mHealth intervention is (content), where it is being implemented (context), and how it was implemented (technical features), to support replication of the intervention. This paper presents the resulting 16 item checklist and a detailed explanation and elaboration for each item, with illustrative reporting examples. Through widespread adoption, we expect that the use of these guidelines will standardise the quality of mHealth evidence reporting, and indirectly improve the quality of mHealth evidence.
While mobile apps are new enough on the care delivery scene that many providers have only begun dabbling, consumers are sending a strong message that forward-thinking hospital executives can translate into an opportunity for improving population health management programs.Northwestern University's Feinberg School of Medicine is conducting clinical trials that use mobile health apps to do much more than just communicate with patients — the software teaches mental health patients cognitive behavioral therapy, or CBT, techniques designed to improve population health and reduce mental healthcare costs.This story is part of a reporting package on the rise of population in health in healthcare IT management. Stories include our analysis of health system strategies, an overview of the work done by Essentia Health and a look at how mobile apps are supporting initiatives.Designed by Northwestern's Center for Behavioral Intervention Technologies, the ThinkFeelDo website (a responsive design site built to render effectively on any device) and the IntelliCare suite of mobile apps (available in the Google Play store for Android devices, with Apple iOS apps in the works) break up the various CBT techniques into separate modules to make learning the techniques and applying them in situations an easier task.The modules include text, animation and video. Caregiver coaches, on the other end of the mobile site and apps, review patient progress and can intervene during lessons to help patients with any challenges or issues and to provide encouragement."Costs can be saved by giving depressed patients these kinds of tools, decreasing overall health care utilization for an individual," said Kenneth R. Weingardt, scientific director at the Center for Behavioral Intervention Technologies. Weingardt also is a licensed psychologist."We are now saving more money because the cost of the app is much lower than the cost of face-to-face. For some folks who are fairly well-functioning and can go it alone, these types of technology may provide them with what they need so they do not have a long depressive episode that impacts their health and costs a health plan money."ThinkFeelDo and IntelliCare are still in clinical trials at Northwestern, though CBITs is in discussions with Kaiser about deploying IntelliCare through its patient portal."Mobile interventions have much farther reach than individual providers can have," Weingardt said. "They can reach many more people beyond those we can see in our clinic. And a health system that adopts these kinds of tools can improve their bandwidth and their ability to address these problems beyond the capacity of their workforce.”[Like Healthcare IT News on Facebook]In the Northwestern’s clinical trials, Weingardt added, that means giving participants tools to get symptoms under control and making it less likely they will come back with complaints.Providers such as Northwestern and other simply cannot ignore the trend toward mobile tools any longer, said population health management vendor Enli Health Intelligence chief medical officer Joseph Siemienczuk, MD."We have to follow the communication preferences of the community and and it is clear that their communication preferences have moved to mobile technology,” Siemienczuk said. "As we pursue effectiveness, moving patient engagement activities to mobile technology is an imperative."Twitter: @SiwickiHealthIT
Via Alex Butler
According to Deloitte’s 2013 Survey of U.S. Health Care Consumers shows that despite strong interest in mobile health (mHealth), consumer adoption of mobile health technologies remains limited. The limited consumer mhealth adoption is being fueled by key concerns surrounding:
Privacy and security
Skepticism about app accuracy
Gaps between consumers’ wants and the industry’s ability to deliver
If consumers can easily embrace mobile enabled technology from shopping, traveling and banking, then why not embrace mobile health?
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