Currently health apps do not have to pass any standards for scientific validity. In fact, some could be harmful!
This article gives an overview of current regulation and evaluation efforts by the government, medical societies, and others.
Excerpts from the Health Care Blog item Are Health Apps the Cure for Anything That Ails You?
With about 9,000 consumer health apps currently available in the iTunes store, it seems like almost all smart phone users can download their way to better health these days.
“Apple isn’t testing apps for their scientific validity,” said Dan Cohen, a social worker who has reviewed apps for their effectiveness.
Given the stakes, it’s no surprise that the government is starting to regulate these smart phone applications. Just last month, the Federal Trade Commission brought its first cases against the makers of two health apps. Each claimed to cure acne with colored lights emitted from cell phones.
“Smart phones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” the FTC chairman said, when announcing the crackdown. The agency cited the makers of AcneApp, which had sold about 11,600 downloads of its $1.99 app, and the developers of AcnePwner, which sold 3,300 downloads of its 99 cent app.
The Food and Drug Administration (FDA), meanwhile, proposed regulations this summer for apps that could be considered medical devices. The agency, which sought comments on its proposals until Oct. 19, may focus on apps that are accessories to established medical devices used by doctors, such as smart phone apps that can display X-rays.
It could also regulate apps that transform smart phones into medical devices by using sensors or other attachments. Already, the FDA has approved gadgets that turn smart phones into blood pressure-monitoring cuffs and pocket ultrasound machines.
Apps that connect to consumer devices, such as blood glucose meters, may be regulated, too, if the apps display or analyze the meters’ readings, the FDA says.
The majority of health apps will almost certainly not be considered medical devices and will escape government scrutiny. But some app developers are voluntarily going through the laborious FDA clearance process, in part, to convince the medical community that their products have real clinical value.
WellDoc, a Baltimore-based health care company, got FDA approval last year for its DiabetesManager, which provides automated diabetes coaching for patients. The app also was tested in a randomized clinical trial conducted by the University of Maryland’s medical school, which found that patients had a statistically significant improvement in their blood glucose levels after using the app for a one-year period.
Scientists have found flaws with other apps.
When a George Washington University professor conducted the first content analysis of behavior-modification apps, she discovered that few of the 47 smoking-cessation apps available in 2009 followed evidence-based health guidelines. Lorien Abroms, a public health professor, concluded that the apps had “serious weaknesses” because they did not link to quit lines or clinics or suggest ways for smokers to get social support from family and friends.
- Smartphone Apps Can’t Cure Acne (bellasugar.com)
- FDA Proposes Health ‘App’ Guidelines (jflahiff.wordpress.com)
- FTC Charges mHealth Apps With False Advertising – No Scientific Evidence for Curing Acne So There’s Not An App for That (ducknetweb.blogspot.com)
- FTC Approves Final Settlement Orders Against Marketers Who Claimed Their Mobile Apps Could Cure Acne (ftc.gov)
- Should Mobile Medical Apps Require FDA Approval? (informationweek.com)
- FDA Review of Some Medical Apps May Be Increased (socialtimes.com)
- Is It Really FDA Approved? (everydayhealth.com)
- Mobile Medical Apps Supervision By FDA, Agency Seeking Input (medicalnewstoday.com)
- FTC: Smartphone apps do not cure acne (news.consumerreports.org)
- Can the iPad cure what ails us? (macworld.com)
- Apps for What Ails You (technologyreview.in)
- FDA will have a plan for healthcare mobile apps in 2012. In the meantime… (medcitynews.com)
This October 24th Popular Mechanics story includes
- How text messaging is used to coordinate health care by health care professionals in rural areas across long distances
- How text messaging in Haiti was used to locate victims in search and rescue efforts despite language barriers
- Camera phones as diagnostic aids
The notion that SMS could revolutionize healthcare first entered Nesbit’s mind in 2007, when he was still a Stanford undergrad. He’d just met Dickson Mtanga, a community health worker in rural Malawi who was walking 35 miles to deliver handwritten patient charts to the nearest hospital. Nesbit biked out to Mtanga’s village one day, only to discover that his cellphone got a better signal there than it did on Stanford’s campus in Palo Alto, Calif. All those bars of service jumped from the phone’s screen and slapped him across the face: These far-reaching GSM networks, he realized, could connect doctors and patients like never before.
Armed with a $5000 grant, a backpack full of old phones, and a laptop running a GSM modem and the open-source group-texting software called FrontlineSMS, Nesbit started working with the hospital and community health workers to coordinate patient care. The system they put in place allowed Mtanga and others to text in the information on those medical charts rather than making the hours-long trek. Patients could text their symptoms to doctors, cutting down on unnecessary visits for minor ailments and freeing up space for those in need of serious care. Within six months of the system going live, the number of patients being treated for tuberculosis doubled, more than 1200 hours in travel time were eliminated, and emergency services became available in the area for the first time. The operating costs in those six months: $500, Nesbit saysThe explosion of cellphone use around the world has inspired a flood of new ideas about how to use that tech to improve healthcare. Besides Nesbit’s Medic Mobile, there are also ideas to turn camera phones into cheap diagnostic tools for vision problems or malaria, for example.
Patty Mechael, executive director of the U.N. Foundation’s mHealth Alliance, keeps tabs on these new techs. They all face major infrastructure hurdles, such as the lack of reliable energy sources to power phone chargers in some developing countries. But another, less tangible challenge is figuring out what mobile health programs are actually working and worth scaling up, and which ones aren’t. “What we have in mHealth are millions of flowers blooming, in many ways. Lots of pilots are being done throughout the world, many of which are reaching populations of a few thousand each,” Mechael says. “We’re at a tipping point where people are starting to say, ‘Okay, we need to be a bit more strategic, collaborative, cohesive.’”
Nesbit is among the voices calling for a more focused approach to mobile health. A wave of angst washes over his face when I ask if there’s too much hype surrounding mobile health, if it’s too saturated of a field. Hype is good, he says. What’s bad is hype that’s disconnected from implementation. All the media coverage and promises made about mobile health in recent years, he says, make it seem as if millions of health workers in developing nations have already integrated their phones into their daily practice. In reality, only about 20,000 have done so. Medic Mobile has SMS systems operating in 14 countries, and that number will jump to 20 in the next six months. Only a few thousand people are using Medic Mobile’s programs today, but the nonprofit just rolled out its first SIM card application, which can be used on virtually every mobile phone in existence. By 2015, Nesbit expects to have 500,000 community health workers using SMS applications to link patients with doctors.
If he hits those numbers, ubiquity really will be the killer app.
- How Your Discarded Phone Can Improve Global Health (newser.com)
- BellVoz Launches a New Communication Service, Direct SMS, Allows Customers to Send International Text Messages from their Mobile Phone, at a Lower Cost (prweb.com)
- Mobile Medicine (andrewsullivan.thedailybeast.com)
- How Mobile Phones Are Saving Lives in the Developing World (mashable.com)
The National Library of Medicine (NLM), wishes to congratulate the five winning entries in the Library’s software development challenge, “Show off Your Apps: Innovative Uses of NLM Information.” In addition, we thank all Entrants for participating in the Library’s first software development challenge!
GLAD4U (Gene List Automatically Derived For You) is a new, free web-based gene retrieval and prioritization tool, which takes advantage of the NCBI’s Entrez Programming Utilities (E-utilities). Upon the submission of a query, GLAD4U retrieves the corresponding publications with eSearch before using Pubmed ID-Entrez Gene ID mapping tables provided by the NCBI to create a list of genes. A statistics-based prioritization algorithm ranks those genes into a list that is output to the user, usually within less than a minute. The GLAD4U user interface accepts any valid queries for PubMed, and its output page displays the ranked gene list and information associated with each gene, chronologically-ordered supporting publications, along with a summary of the run and links for file exports and for further functional enrichment analyses.
Learning anatomy interactively with a touchscreen device is dynamic and engaging. Having it as an app, makes the information available anywhere, anytime. iAnatomy is an exciting electronic anatomy atlas for iPhone/iPod touch. The images are interactive and zoomable. If a label is touched, the name of the structure is shown. Images span from the face to the pelvis. The face and neck images and the female pelvis images are reconstructed from data from the National Library of Medicine’s Visible Human Project. iAnatomy is designed to stand on its own and does not require an ongoing internet connection. Learning is reinforced with multiple quiz modes. Latin medical terminology is also included as an option for international use.
The KNALIJ web application addresses the challenges and opportunities posed by ‘big data’ with a new generation of information visualization tools. It offers researchers, students and health consumers alike a technology platform with capabilities to rapidly discover and gain insights from the copious amounts of information being made available from the National Libraries of Medicine (NLM), through its data repositories such as PubMed. KNALIJ recognizes the ‘connections’ linking bio-medical and life sciences research and researchers around the world, and visualizes those linkages. This makes them clear, intuitive, and even playful by providing interactive ‘information communities’ for exploration, analysis, and education.
NLMplus is an innovative semantic search and discovery application developed by WebLib LLC, a small business in Maryland. NLMplus provides enhanced access to the vast collection of health and biomedical information and services made available by the world’s largest medical library, the National Library of Medicine (NLM).
Quertle is an innovative website for searching and investigating the biomedical literature. Quertle uses advanced linguistic methods to find the most relevant documents instead of traditional keyword searching, which often returns an overwhelming list of uninformative articles. Quertle is geared to active life science professionals – both researchers and health care providers – and saves them considerable time and effort in finding the literature they need. Quertle, available on the web using any browser, simultaneously searches multiple sources of life science literature, including MEDLINE.
The BioDigital Human Platform simplifies the understanding of health topics by visualizing anatomy, conditions and treatments. Similar to how geo-browsers such as Google Earth serve as the basis for thousands of location based applications, the BioDigital Human Platform will open up entirely new ways to augment healthcare applications. From the visual representation of concepts found on health portals, to step-by-step virtual guidance for surgical planning, to EHR integration so patients can finally understand their diagnosis, the BioDigital Human Platform will meet the learning demands of 21st century medicine.
DailyMedPlus is an online application providing integrated access to pharmaceutical information available from various databases provided by the National Library of Medicine (NLM). DailyMedPlus offers a high-performance unified search engine providing ranked, highlighted and full-text search results for patients and healthcare professionals who seek updated prescribing information. As the only product of its kind, the application supports searching NLM databases for pharmaceutical products using trade and generic names, medical conditions, indications, contra-indications, side-effects, and also allows for the searching of these products by their physical characteristics (“red round”), providing image results in an in line intuitive layout. Users benefit from comprehensive search results of more than 90,000 products displayed in over 26,000 organized and digitally curated monographs designed for browsing on a wide variety of desktop and mobile platforms.
Drug Diary is an iOS (iPhone / iPod Touch / iPad) application that allows users to quickly build an inventory of prescribed and OTC medications they are currently taking or have taken in the past along with information on the associated prescribers and pharmacies. From there, they are able to take notes outlining their experiences with these medications and generate reports to share with care providers. Data entry is made quick and easy through the use of a locally cached copy of the NLM’s RxTerms dataset and intelligent data entry screens that require little to no typing. The app leverages the data present in RxTerms to allow one tap access to another NLM source, MedLine Plus, which is a web portal that provides detailed information on the medications in the user’s library.
Molecules is a 3-D molecular modeling application for Apple’s iOS devices, including the iPad, iPhone, and iPod touch. It pushes the limits of mobile graphics processors by using advanced techniques to make realistic renderings of molecular models. A touch-based interface allows for intuitive manipulation of these structures, so that they can be viewed from any angle and at any scale. While originally designed for researchers to view and present biomolecule structures on the go, the most popular use of Molecules has proven to be in education. Chemistry teachers are using this application to explain common molecular structures to their students, and biology professors are demonstrating the form and function of biomolecules. Many students already have iOS devices of their own, so they are able to make the lesson more personal by following along on their own iPhone or iPad. The popularity of this approach is seen in the over 1.7 million downloads of this application to date.
Orkov is a Greek term for Hippocratic Oath that medical professionals, especially, physicians take all over the world. Orkov, an iPhone App for iOS 5 platform as well as for Android OS is a productivity smart phone application for hundreds of thousands of medical researchers who are the end users of PubMed.gov data all over the world. Orkov empowers many researchers to search and browse research abstracts and full text research articles from the repository of PubMed.gov’s over 5,000+ research journals. Orkov utilizes publicly available web service interface of PubMed.gov. Majority of the features of PubMed.gov are wrapped into a powerful iPhone/Andorid App that is easy to use and navigate.
- Quertle, a Life Sciences Semantic Search Engine, Wins a National Library of Medicine Award (biojobblog.com)
A few years ago, Father Tomasz Trafny was brainstorming with other Vatican officials about what technologies would shape society, and how the Vatican could have an impact. And it hit them: Adult stem cells, which hold the promise of curing the most difficult diseases, are the technology to watch.
“They have not only strong potentiality,” says Trafny, “but also they can change our vision of human being[s], and we want to be part of the discussion.”
In a rare move, the Vatican decided to collaborate with a private company, NeoStem, to do education and eventually research. The Catholic Church is investing $1 million to form a joint foundation, and next week, scientists from around the world will meet at the Vatican to discuss the future of stem cell therapies.
Trafny, who is chairman of the science and faith department at the Pontifical Council for Culture, says they believe there’s a superior alternative to embryonic stem cell research.
“We don’t see reason why we have to sacrifice human lives, while we have technologies that do the same without harming anyone and without raising any moral difficulties,” he says.
“What people don’t realize is for 30 years, we’ve been using adult stem cells,” says Robin Smith, the chief executive officer of NeoStem. “That’s called a bone marrow transplant. Diseases like leukemia, lymphoma, multiple myeloma, anemia — this is all part of the standard of care.”..
- Should I Save Stem Cells Now for Future Treatment? (everydayhealth.com)
- How Can I Mobilize Stem Cells for Myeloma? (everydayhealth.com)
- Stem cell hope for elderly patients (telegraph.co.uk)
- Scientists Clone Embryonic Stem Cells from Individuals To Aid In Cure For Diabetes as Reported by DiabeticLive.com (prweb.com)
- Pharmaceutically Speaking, Part 11: Outlawed Stem Cell Patents (tacticalip.com)