Monday, August 29, 2016

Digital Health Space will soon be broadcasting (livestream) weekly. Our production staff is setting up a studio, checking the lights, sound and all the backstage operations. is hosting our event(s). It has several features which excel.  It is user friendly, the platform provides integrated chats, email, invitations, and the ability for community, in which you may join. I encourage you to join, so you will be immediately notified of events.

Video has become a dominant force, and attracts many people instead of the written word of blogging, emails, autoresponders and spammers.

I welcome questions and suggestions for future livestream events.

These events will be a combination of serious discussion, entertainment, and social engagement.

There will be several announcements forthcoming on Facebook, Google +, Twtiter, Sermo, and others.

I will be sending you the unique identifier for the Digital Health Space LiveStream.

Please share the news.


Saturday, August 27, 2016

FDA declines to scrutinize manufacturer claims for “low risk” mhealth apps, devices. What’s the takeaway?

Here in the US of A the Food and Drug Administration holds sway over regulating medical devices and medications. They analyze claims of effectiveness and transparency from companies that produce medications and biomedical devices.  Prior to regulating such things they analyze possible risk factors of devices used on patients.

The FDA is tight lipped about approving such things, and often the US of A is the last to approve medications and devices. The U.K. and countries in the Euro-zone approve much before the FDA. Almost all device and drug manufacturers  outsource their R&D to foreign zones.

The regulatory burden is more than enormous.  It adds to the cost of development.

The scope of such regulations is enormous.

FDA said it will ease up vetting general health and wellness apps, but it will scrutinize clinical applications and devices. Does this mean the FTC will step up?

The U.S. Food and Drug Administration has issued final guidance on “low-risk” digital health apps and devices for general health management 18 months after it  came out with draft guidance.

The document offers information on the kinds of apps and devices for which it will and won’t take action. Apps promoting or maintaining a healthy weight or to assist with weight loss goals and healthy eating are OK.  The guidance says that companies can make claims that their apps and devices can help with healthy lifestyle choices to reduce the risk of chronic conditions such as Type 2 diabetes, high blood pressure and heart disease or improve their management. But those lifestyle choices have to be advocated by the likes of the American Heart Association or American Association of Clinical Endocrinologist or peer-reviewed medical journals.

So what are some examples of what’s not OK? Claims that a product will treat or diagnose obesity, an eating disorder, such as bullimia or anorexia, or an anxiety disorder. Digital health entrepreneurs are also encouraged to ask themselves the following questions:

Is the product invasive?
Is the product implanted?
Does the product involve an intervention or technology that may pose a risk to
the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
If the answer is yes to any of the above, they need to assume their products are considered clinical applications, will be scrutinized and should act accordingly.

My takeaway from the guidance is twofold. It’s a question of resources. Although there are thousands of general wellness apps, more and more medical device and pharma companies are developing digital health devices and apps of their own.  Second, the Federal Trade Commission has shown it is willing to take action against companies that it deems to be making false health claims about their apps and devices.

The distinction now is 'false claims" such as those made by Focus Education , which produces.

The Federal Trade Commission has singled out Focus Education for making what it calls unsubstantiated claims for its computer game, including that it “permanently improves” children’s focus, behavior and children with ADHD, according to a statement from the FTC.

In another consent agreement the FTC takes action against melanoma app marketing claims, and concerns over consistency. They also took action against  Moledetective  another smartphone app

FDA declines to scrutinize manufacturer claims  and shifts regulation to the Federal Trade Commission.

Thursday, August 25, 2016

Is the post-EHR era upon us? | Healthcare IT News

I would not be so bold as to claim the title of this blog.  However there are some that posit this idea.

Several mandates are still in effect.  As Mark Segal, chair of the HIMSS Electronic Health Record Association, reminds us: "Meaningful use is forever." And EHR  carries with it the long shadow of incentives and penalties which in the long run are very significant.

Many in the health and health IT industry are saying meaningful use is dead, due to it's complexity and the cost of upgrading current EMR systems to comply with CMS and HHS mandates. HIT vendors and health providers are justified in offering their opinion of non-attainability of the MU goal stage III.

Upon hearing of the Centers for Medicare & MedicaidServices' August Stage 2 rule change – ostensibly meant to offer more flexibility, but also requiring 365 days of EHR reporting in 2015 – CHIME CEO Russell Branzell struck an apocalyptic tone.
"CHIME is deeply disappointed," he said, echoing frustration held by many other stakeholders on the provider and technology vendor sides. "Now the very future of meaningful use is in question."
Upon learning of the rules newly-onerous requirement, one commenter on was more willing to put it definitively: "Lets all take a deep breath, and say it: Meaningful use is dead. Now is the time to figure out what to do next."
Whether or not there's any such thing as a "post-meaningful use" era, there's been plenty of discussion recently of a "post-EHR era" – one in which, with the basic commodity of electronic health records now in place and in use, the technology can evolve and improve: better usability and design, mobile device interfaces, more seamless interoperability. 
Although the vast implementation of EHR, MU I has taken place, many say it failed, largely because the Federal government hastily mandated a too short plan to implement it. They did the same with the Affordable Care Act. Passing both of these laws and the small print within was a political expediency...a rush to get it passed rather than a framework for success.  Success cannot be measured by one factor, as to how many people  have a card in their wallet which claims they have health benefits.  Most people do not have better care, cannot access a physician, and cannot afford the deductibles.

New to-do lists loom for 'post-EHR era'

It is patently obvious the regulatory burden increases each  year at the expense of patient care. Much of the "quality metrics" amount to checking off the boxes to reach HEDIS and MEDSTAR rankings. In some cases patient engagement is measured by how many times an insurer calls a patient without being asked to for things such as life issues, pharmaceutical needs. In one day I received three different phone calls from Human asking me if I needed any help.  I was offered a house call 'free' since they had a  mobile MD in my neighborhood. It took several 'NOs" to convince the care manager that I had just seen my doctor. The next call was from another case manager...about ten minutes apart wanting to review my medication list. The third call was from another asking me how I was doing after my spouse had passed six months ago.  This was a routine monthly checkup on my well-being.

On the face of it, it all seems well intentioned and that my doctors care about me. Perhaps I have become cynical....and perhaps there are patients that require this much pro-active care-giving. I am fortunate I have my wits about me (I think) even if I am 73, have had several major  heart adventures and one small stroke. Since I have young adult children they manage me quite well. (there should be an opt-out for the computerized checklist.  The whole thing is on automatic pilot, from voice mail to phone trees to managed care.  The infrastructure eats up any savings in actual patient care, in fact it seems as if the patient care savings were designed to finance the parasitic administrative burden.

Health insurers now practice medicine, they set the standards for payment, and use practice patterns to judge the quality of care. They call patients at home without permission or knowledge by the doctor....It is all okay because I am told the call is recorded for quality measures....(who listens to these recordings?

Are we in Kansas Dorothy ?

Is the post-EHR era upon us? | Healthcare IT News