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FDA Announces Precertification Program For Digital Health Tools

Posted on October 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process.

The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data.

Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards.

Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency.

If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s worth noting that these rules would apply to lower-risk settings.)

The prospect of pre-certifying companies does raise some concerns. In truth, the argument could be made that digital health software should be regulated more tightly, not less. In particular, the mobile healthcare world is still something of a lawless frontier, with very few apps facing privacy, security or accuracy oversight.

The fact is, it’s little wonder that physicians aren’t comfortable using mobile health app data given how loosely it can be constructed at times, not to mention the reality that it might not even measure basic vital signs reliably.

It’s not that the healthcare industry isn’t aware of these issues. about a year ago, a group of healthcare organizations including HIMSS, the American Medical Association and the American Heart Association came together to develop a framework of principles dressing app quality. Still, that’s far short of establishing a certification body.

On the other hand, the FDA does have a point when it notes that a pre-certification program could make it easier for useful digital health tools to reach the marketplace. Assuming the program is constructed well, it seems to me that this is a good idea.

True, it’s pretty unusual to see the FDA loosen up its certification process – a fairly progressive move for a stodgy agency – while the industry fails to self-regulate, but it’s a welcome change of style. I guess digital health really is changing things up.

 

The First Ever “Unchat” – #HITsm Chat Topic

Posted on September 12, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

We’re excited to share the topic and questions for this week’s #HITsm chat happening Friday, 9/15 at Noon ET (9 AM PT). This week’s chat will be hosted by…

That’s right! The #HITsm chat is going rogue this week. The #HITsm chat on Friday, 9/15 at Noon ET (9 AM PT) will have no agenda, no host, and no organization. It will be an hour long #HITsm free for all where anyone can propose any topic, thought, idea, meme that they want. You can share a link, a picture, a thought, a question, or anything else you feel like sharing.

Where this will end, no one knows, but that’s what makes it so exciting! If it falls flat, we’ll blame workflow and never do it again.

This chat was inspired by @burtrosen who asked for a chat where the #HITsm community can have a chance to “blow off steam.” I loved the idea and the “unchat” was born. There are so many great people in the #HITsm community, I’m sure that some amazing conversations will happen in this chat and likely on unexpected topics. Not to mention that random conversations are a great way to inspire new relationships.

To be clear, this is a true unchat. Those that join and participate will start the topics, extend the topics, ask questions, etc. The topics don’t even have to be related to health IT. If you want to talk about your holiday vacation plans, go for it. Is there a part of healthcare IT that’s really bothering you or has you really excited, let’s hear it. If you like cats as much as Brian Eastwood, share a cat photo. If you’ve fallen in love with your healthcare chat bot and want everyone to know it, share away. Of course, this is a community, so just be respectful and appropriate the way you’d be if we were hanging out or having dinner.

Given that this is an unstructured #HITsm unchat, there won’t be any formal questions for the chat. The threads will start and extend however the community sees fit. However, we will throw out this first question to get things started and the community thinking:

T1-5: What’s on your mind? #HITsm

We hope you’ll join us for this new #HITsm Unchat. Let’s get to know each other in new and unique ways.

Upcoming #HITsm Chat Schedule
9/22 – The Impact of HIEs in Natural Disasters
Hosted by Brian Mack (@BFMack) from @GLHC_HIE

9/29 – Condition Management vs Episodic Care Management
Hosted by Brian Eastwood (@Brian_Eastwood) from @ChilmarkHIT

10/6 – After Death Data Donation – A #hITsm Halloween Horror Chat
Hosted by Regina Holliday (@ReginaHolliday), Founder of #TheWalkingGallery

10/13 – Role of Provider Engagement for Improving Data Accuracy
Hosted by @CAQH

We look forward to learning from the #HITsm community! As always, let us know if you’d like to host a future #HITsm chat or if you know someone you think we should invite to host.

If you’re searching for the latest #HITsm chat, you can always find the latest #HITsm chat and schedule of chats here.

Digital Health Innovation in Pharma – #HITsm Chat Topic

Posted on September 5, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

We’re excited to share the topic and questions for this week’s #HITsm chat happening Friday, 9/8 at Noon ET (9 AM PT). This week’s chat will be hosted by Naomi Fried (@naomifried) on the topic of “Digital Health Innovation in Pharma.”

The digital health revolution is in full swing. Each year, more and more digital innovations are coming to market that leverage hardware and software to provide new ways of delivering care and information to patients and providers. These solutions can improve outcomes, drive down costs, and/or boost efficiency.

Healthcare stakeholders are beginning to understand digital health’s ability to radically reshape the healthcare landscape. While many firms in the pharmaceutical and biotech sector (“biopharma”) are only slowly awakening to digital health’s potential, some forward-thinking biopharma companies are aggressively looking for ways to use digital health to strengthen their businesses. They see it as critical to improving patient outcomes, building connections with providers and patients, strengthening their brand, and driving new revenues.

Join our Twitter chat as we explore the growing opportunity for digital health innovation in pharma and biotech. We’ll discuss some of the exciting opportunities that are emerging; what is working and what isn’t; and which business models seem to be succeeding. Share your thoughts during our conversation September 8th at 9-10 am PT!

Reference Materials:

Here are the questions that will serve as the framework for this week’s #HITsm chat:
T1: What are the best #patient-facing digital health solution currently deployed by #pharma & #biotech? #HITsm

T2: What is exciting in “#digiceuticals” (mobile apps & software that treat #medical conditions)? #HITsm

T3: How are #pharma & #biotech effectively leveraging digital health tools to improve and extend communication with providers? #HITsm

T4: What is impeding the deployment of #digitalhealth by #pharma & #biotech? What could help? #HITsm

T5: Buy, build, partner? What models are going to be most successful for #pharma and #biotech to get into #digitalhealth? #HITsm

Bonus: If you were master of the #digitalhealth universe & could make a major change in the #healthcare ecosystem, what would it be? #HITsm

Upcoming #HITsm Chat Schedule
9/15 – Unchat
This chat will have no agenda and no topic. It will be a community free-for-all where anyone can introduce any topic, subject, question, image, video, etc that they want. This could get interesting.

9/22 – TBD
TBD

9/29 – TBD
TBD

We look forward to learning from the #HITsm community! As always, let us know if you’d like to host a future #HITsm chat or if you know someone you think we should invite to host.

If you’re searching for the latest #HITsm chat, you can always find the latest #HITsm chat and schedule of chats here.

A Hamilton Pharma Love Song – Fun Friday

Posted on February 3, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

It’s almost Super Bowl weekend and I know many of you are already off getting ready for your Super Bowl parties. That’s why we bring you another Fun Friday. This is another ZDoggMD classic to “You’ll Be Back” from the Hamilton musical (which is extraordinary if you haven’t seen it yet). If you’re in healthcare, you’re going to love this and hate this at the same time. In fact, that pretty much describes all of ZDoggMD’s videos.

Have a great weekend!

CVS Launches Analytics-Based Diabetes Mgmt Program For PBMs

Posted on December 29, 2016 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

CVS Health has launched a new diabetes management program for its pharmacy benefit management customers designed to improve diabetes outcomes through advanced analytics.  The new program will be available in early 2017.

The CVS program, Transform Diabetes Care, is designed to cut pharmacy and medical costs by improving diabetics’ medication adherence, A1C levels and health behaviors.

CVS is so confident that it can improve diabetics’ self-management that it’s guaranteeing that percentage increases in spending for antidiabetic meds will remain in the single digits – and apparently that’s pretty good. Or looked another way, CVS contends that its PBM clients could save anywhere from $3,000 to $5,000 per year for each member that improves their diabetes control.

To achieve these results, CVS is using analytics tools to find specific ways enrolled members can better care for themselves. The pharmacy giant is also using its Health Engagement Engine to find opportunities for personalized counseling with diabetics. The counseling sessions, driven by this technology, will be delivered at no charge to enrolled members, either in person at a CVS pharmacy location or via telephone.

Interestingly, members will also have access to diabetes visit at CVS’s Minute Clinics – at no out-of-pocket cost. I’ve seen few occasions where CVS seems to have really milked the existence of Minute Clinics for a broader purpose, and often wondered where the long-term value was in the commodity care they deliver. But this kind of approach makes sense.

Anyway, not surprisingly the program also includes a connected health component. Diabetics who participate in the program will be offered a connected glucometer, and when they use it, the device will share their blood glucose levels with a pharmacist-led team via a “health cloud.” (It might be good if CVS shared details on this — after all, calling it a health cloud is more than a little vague – but it appears that the idea is to make decentralized patient data sharing easy.) And of course, members have access to tools like medication refill reminders, plus the ability to refill a prescription via two-way texting, via the CVS Pharmacy.

Expect to see a lot more of this approach, which makes too much sense to ignore. In fact, CVS itself plans to launch a suite of “Transform Care” programs focused on managing expensive chronic conditions. I can only assume that its competitors will follow suit.

Meanwhile, I should note that while I expect to see providers launch similar efforts, so far I haven’t seen many attempts. That may be because patient engagement technology is relatively new, and probably pretty expensive too. Still, as value-based care becomes the dominant payment model, providers will need to get better at managing chronic diseases systematically. Perhaps, as the CVS effort unfolds, it can provide useful ideas to consider.

Connected Wearables Pose Growing Privacy, Security Risks

Posted on December 26, 2016 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

In the past, the healthcare industry treated wearables as irrelevant, distracting or worse. But over that last year or two, things have changed, with most health IT leaders concluding that wearables data has a place in their data strategies, at least in the aggregate.

The problem is, we’re making the transition to wearable data collection so quickly that some important privacy and security issues aren’t being addressed, according to a new report by American University and the Center for Digital Democracy. The report, Health Wearable Devices in the Big Data Era: Ensuring Privacy, Security, and Consumer Protection, concludes that the “weak and fragmented” patchwork of state and federal health privacy regulations doesn’t really address the problems created by wearables.

The researchers note that as smart watches, wearable health trackers, sensor-laden clothing and other monitoring technology get connected and sucked into the health data pool, the data is going places the users might not have expected. And they see this as a bit sinister. From the accompanying press release:

Many of these devices are already being integrated into a growing Big Data digital health and marketing ecosystem, which is focused on gathering and monetizing personal and health data in order to influence consumer behavior.”

According to the authors, it’s high time to develop a comprehensive approach to health privacy and consumer protection, given the increasing importance of Big Data and the Internet of Things. If safeguards aren’t put in place, patients could face serious privacy and security risks, including “discrimination and other harms,” according to American University professor Kathryn Montgomery.

If regulators don’t act quickly, they could miss a critical window of opportunity, she suggested. “The connected health system is still in an early, fluid stage of development,” Montgomery said in a prepared statement. “There is an urgent need to build meaningful, effective, and enforceable safeguards into its foundation.”

The researchers also offer guidance for policymakers who are ready to take up this challenge. They include creating clear, enforceable standards for both collection and use of information; formal processes for assessing the benefits and risks of data use; and stronger regulation of direct-to-consumer marketing by pharmas.

Now readers, I imagine some of you are feeling that I’m pointing all of this out to the wrong audience. And yes, there’s little doubt that the researchers are most worried about consumer marketing practices that fall far outside of your scope.

That being said, just because providers have different motives than the pharmas when they collect data – largely to better treat health problems or improve health behavior – doesn’t mean that you aren’t going to make mistakes here. If nothing else, the line between leveraging data to help people and using it to get your way is clearer in theory than in practice.

You may think that you’d never do anything unethical or violate anyone’s privacy, and maybe that’s true, but it doesn’t hurt to consider possible harms that can occur from collecting a massive pool of data. Nobody can afford to get complacent about the downside privacy and security risks involved. Plus, don’t think the nefarious and somewhat nefarious healthcare data aggregators aren’t coming after provider stored health data as well.

Practice Fusion EMR Brings Patients Into The Picture

Posted on April 22, 2013 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Practice Fusion was one of the first free, advertising supported, cloud-based EMR to enter the market and has likely been the loudest proponent of free EMR software. Although, they have some interesting Free EMR competitors like Mitochon and Kareo. Since 2007, Practice Fusion has focused on offering unfettered access to its product in exchange for physicians being willing to accept advertisements relevant to the health records they’re using and the aggregate use of the EHR data.

The company, which has raked in venture capital in buckets since its founding, now says it has 150,000 healthcare providers using its EMR and records on 60 million patients, according to a piece in The New York Times.

Now, the company has taken another step in its free-for-all model with a new service it calls Patient Fusion. Patient Fusion is a new service which allows patients using the system to schedule appointments with any participating doctor who uses the EMR. It also allows patients to rate the doctors in question and to access their records with permission. So far, 27,000 of Practice Fusion’s EMR users have signed up for the service, the Times reports.

The Times columnist covering this announcement speculates that Practice Fusion has launched its new product as a means of building up patient traffic, but I don’t see how that would work. Patients may see more of their records, but this won’t necessarily do anything to increase the number of doctor-based views the network can sell to lab companies and pharmas.

On the other hand, Patient Fusion could prove to be a powerful way of attracting and keeping doctors who want to offer easy-to-administer appointment scheduling to patients. Also, getting patients engaged with their medical records is very much in the spirit of Meaningful Use and the ONC’s priorities generally, so this new patient feature could be a beacon for doctors going through MU-motivated EMR switching this year.

Bottom line, this seems like a nifty idea. I predict that most of Practice Fusion’s EMR customers will sign up over the next year or so.

EHR Mouseclicks, #HIT100 Interview, EMR and Doctor-Patient Relationships, and Sleep Rate: Around Healthcare Scene

Posted on July 29, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

I apologize for not having a weekly round-up last week — my family and I were in Southern Colorado, and while the owner of the lodge we were staying at said there was Internet available, that didn’t prove to be completely true. So for the next two weeks, these posts will have a combination of two weeks’ of posts. There were some great posts recently, and I’d hate for anyone to miss them!

EMR and EHR

Too Many EHR Mouseclicks and Keystrokes – A Solution for EHR Vendors

Critics of EHRs claim that there are too many mouseclicks/keystrokes involved to consider it efficient. However, there are ways to overcome this complaint. If vendors would focus on making their product respond consistently, and physicians get the training they need, this hurdle can be overcome. It may take awhile for this point to be reached, but it is possible.

EMR Advocate Tops the #HIT100

The #HIT100 list aims to recognize great #HITsm and #HealthIT communities on Twitter. This week, the #1 person on the list, Linda Stotsky (@EMRAnswers), was interviewed by Jennifer Dennard. She gives her thoughts on social media and health IT, and how it’s affected her career. Stotsky also reflects on the the value that the #HIT100 list brings to the health care community.

The Intersection of EMRs and Health Information Management

While researching for a discussion she was going to moderate on the exchange of personal health information with an ACO at Healthport’s first HIM Educational Summit, Jennifer Dennard stumbled upon some interesting information. This post contains some of her thoughts, and includes a list of the top 10 trends impacting HIM in 2016. At the conclusion of her article, she asks questions concerning Meaningful Use and the relationship HIM professionals have with EMR counterparts.

Happy EMR Doctor

How an EMR Gets in the Way of Doctor-Patient Relationships

While happy with his current EMR, Dr. Michael West talks about the “darkside” of EMRs. He says that he has to pay more attention to his computer than maintaining eye contact with his patients, but this is a problem that will be difficult to resolve. Although he could just jot notes down and update the EMR later, he feels this would be more time consuming and less accurate. Is there are a solution to the barrier created between doctors and patients when an EMR is used?

Smart Phone Health Care

SleepRate: Improves Your Sleep by Monitoring Your Heart

Everyone has trouble sleeping every now and then. Unfortunately, it’s not always easy to figure out why. SleepRate, a cloud based mobile service, may be the solution. This service tracks and analyzes the users sleep patterns, and, from that information, gives suggestions on how to improve sleep. It does this by monitoring your heart using a ECG.

App Helps Potential Skin Care Victims Track Moles

1 in 5 Americans will be diagnosed with skin cancer in their life. With a chance this high of getting this terrible disease, it’s more important than ever to monitor moles and other skin lesions. An app created by the University of Michigan Health System, UMSkinCheck, makes that monitoring easier. The app sends reminders about skin checks, and allows the user

EMR Thoughts
Digital Health Takes Off in 2012

Digital Health is growing more and more. Rock Health Weekly reported that there is 73 percent more funding for it this year than at this time last year. The yearly funding report by Rock Health Weekly was recently released, and there were several interesting findings in it. Digital Health isn’t going anywhere.

Hospital EMR and EHR

The Meaningful Use Song (To The Tune of “Modern Major General”)

If you need a little pick-me up, or a smile to end your week, don’t miss this video. The “Meaningful Use Song” includes commentary on MU, written by Peggy Polaneczky, MD, to a catch tune.

From The Horse’s Mouth: What Scribes Are For

Ever wonder what a scribe does, and if they are really even needed? This post includes quotes from Scott Hagood, the director of business development for PhysAssist Scribes. This is a great position for pre-med students, and with the growth of EMR, the field for scribes continues to develop and expand as well.

The Pharma-tization of ACOs

Posted on May 18, 2012 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I was sitting in a session at a conference recently that included a representative from a large pharma company. The actual individual and the pharma company are unimportant, but I thought that the comment they made was quite interesting. I don’t think I should have been surprised, because you can turn anything into pharma if you want. Just like I can turn anything into a blog post if I want.

The pharma executive commented on how her pharma company was a little too early to jump on the ACO (Accountable Care Organization) bandwagon. They were going to doctors to tell them about the need to use different drugs in order to provide “more effective” care for patients. By so doing, the doctor will provide better care to the patient and receive a better reimbursement because in the ACO model you’re paid for quality of care not volume.

Let me translate what I believe pharma’s intent really is (although I think it’s quite apparent) in these comments. “You shouldn’t be using our competitors drugs, you should be using our drugs because they’re more effective.” or “You should be using our more expensive drugs because it’s more effective than this cheaper drug.” While a strong generalization, remember the first rule of pharma: Sell more drugs. If this means using the new ACO models to push more drugs so be it. Thus the Pharma-tization of ACOs.

The interesting end to this story was why the pharma executive told us this story. She was really telling us about physicians lack of response to the ACO messaging. Basically this pharma company was ahead of the curve on using the ACO and value based care messaging out there, because physicians aren’t seeing their reimbursement influenced by either today. My guess is that many barely even see ACOs and value based care on the horizon. So, the above pharma messaging was given to deaf ears.

Social Media for Patient Recruitment

Posted on May 1, 2012 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I previously posted about Patient Recruitment & EHR where I talked about some of the intricacies of patient recruitment and use of EHR for clinical study patient recruitment. While I’m certain that EHR will be a major player in the patient recruitment of the future, I saw a tweet today that made a great case for social media being the go to platform for patient recruitment today.

Here’s the tweet from @JeffBrittonMD:

70% of patients were recruited on Facebook. That number hit me when I saw it. Although, after thinking about it a little bit it makes a lot of sense. The real key to Facebook recruitment is that they know a lot of information about you which advertisers can use to target their ads. So, it makes perfect sense for Facebook to work for patient recruitment.

I think we’ll see other social media channels prove beneficial to patient recruitment as well. Although, it’s still early for many of the other platforms that I think will prove most valuable. Keep an eye on Twitter to start. Also, don’t underestimate the power of mobile apps and even a physician’s social media presence.