Glass <3 FDA + HIPAA

This post was originally featured on HIStalk

Lots of people ask me about FDA and HIPAA compliance for Glass. There’s nothing in either of these regulatory frameworks that has unique implications for Glass, even in the most delicate clinical environments such as surgery.

Glass is a computer, just like a smartphone, tablet, laptop, or desktop. It’s not special except that it looks funny. It runs Android, the fastest-growing, widely-used, flexible, extensible operating system known to mankind.

There will be Glass apps that require FDA regulation, but those apps will only require FDA regulation if the same function warranted FDA regulation on smartphones or tablets. Most of the Glass apps being developed inside universities are extensions of the EHR.

As an example, every idea listed by John Halamka, MD, CIO at BIDMC, is an EHR extension. As such, none of these apps will require FDA approval.

Glass isn’t unique within the HIPAA regulatory framework, either. Glass is just another Android device on the network. All data storage and transmissions to and from Glass must adhere to HIPAA protocols, but that’s not unique to Glass.

Moreover, because Glass runs Android, CIOs already know how to manage Glass within their existing IT infrastructure. My company has tested Glass with existing mobile device management (MDM) tools such as AirWatch and it works. MDMs simply recognize Glass as another Android device on the network.

Many have stated that the first-person camera will be the bane of Glass’s existence in hospitals. The camera is a non-issue. Hospitals are already recording everything 24 / 7. In surgery, this is especially true, where hospitals will spend north of $100,000 to install cameras in the OR lights. In fact, most hospitals already give patients waivers (that they don’t read) stating that the hospital has a right to record everyone inside.

In many ways, Glass is more regulation-friendly than traditional computers and smartphones because:

  1. Glass doesn’t have a cellular chip, meaning it doesn’t support texting.
  2. Glass’s proximity sensor can detect when the device is taken on and off. Unlike traditional computers, which can be physically hijacked within 2-3 minutes of last use if the user forgets to lock / logout, Glass is physically un-high jackable.
  3. Glass won’t store any personal information, contacts, or connections. At Pristine, we’re removing the consumer-centric timeline user interface and replacing it with our own that’s hospital-centric. As such, users won’t have access to anything except hospital-specific functions. That means no texting, no Gmail, no Twitter, no SnapChat, no Instagram, etc.

Lots of people are trying to understand how Glass will reshape healthcare. Quite a few universities and hospitals are already testing Glass internally. A handful of venture-backed startups in addition to mine that are trying to reshape healthcare on Glass.

Surprisingly, I’ve seen little Glass activity out of the older healthcare IT vendors. I guess I shouldn’t have been so surprised. After all, this is healthcare IT.

Understanding the ACO Pioneers Successes and Failures

First year pilot numbers are out for the first ACOs. They're a mixed bag. About 1/3 performed well, 1/3 did mediocre, and 1/3 are anxiously leaving the ACO pioneer program.

People like to yell and scream as the healthcare system changes. It's difficult. A lot of legacy healthcare pundits were happy with the results of the ACO pioneer program because the data didn't appear to be overwhelmingly supportive of ACOs. But the data is actually extremely supportive of ACOs.

The hardest thing to do in a startup is prove product viability (I haven't; I still sell dreams). Similarly, paradigm shifting payment structures must prove viability. The leading 1/3 of ACOs did in their first year trying. 1/3 is phenomenal.

But what about the 2/3 that failed? Well...

How many companies with thousands of employees across dozens of physical locations with a broad base of skills in a very rigid hierarchy have successfully inverted their revenue models and associated cost structures in 1-2 years utilizing mostly unproven technologies? 2/3, if not 9/10, were destined to fail. No amount of normalization of data can account for inadequate and unprepared management in a radically new revenue and cost structure. ACOs will disrupt fee-for-service (FFS) providers because ACOs employ a disruptive business model that solves Clayton Christensen's jobs to be done theory. FFS providers job is to administer more care. ACOs job is to keep you healthy and out of clinic / hospital. ACOs are fundamentally aligned with patients health needs, FFS providers are not. As such, in the long run, they will deliver the best care at the lowest prices. These first batch of successful ACOs are a harbinger of what's to come.

Now all that's left to be done is to propagate the management practices of the best to the rest.

 

A Day in the Life of a Startup CEO

5:30 AM: wake up using Sleep Cycle, check Mailbox in bed. I want folks to know that I'm up early working.

5:55 AM: begin 1.5 mile run, always in Vibrams

6:30 AM: setup rings on a tree, workout, drink post workout shake, shower, shave, etc

7:30 AM: on the road to Capital Factory

8:00 AM: begin working. Here are some pictures of the views of and from Capital Factory (here and here and here and here and here). Work consists of:

emails

emails

emails

emails

phone calls

phone calls

begging for money

interviews

meetings

blogging

I take most of my phone calls on this bean bag, or in one of these phone booths.

6:30 PM: Attend a developer event, usually conveniently located at Capital Factory or on 6th Street

8:00 PM: go home

8:30 PM: work from home

12:00 AM: sleep

 

Interview: Paris Wallace, Founder, CEO, Ovuline

This interview was originally featured on HIStalk. I forgot to post the last 5 interviews when they were originally published on HIStalk, so they're here all in one big chunk. Moving forward, I'll make sure to post interviews as they're published.

Paris Wallace is founder and CEO of Ovuline of Boston, MA. 

What does Ovuline do?

Ovuline uses data to help women conceive and have healthier pregnancies. Women share their key health information with us,  both from what they observe as well as data they gather from wearable health tracking devices. We take that data and analyze it with machine learning algorithms and clinical guidelines to help them achieve their fertility and pregnancy health goals.

Is your system an expert system, a data-driven system, or some combination of the two?

Some combination of the two, but we’re mainly data-driven. Our systems use machine learning algorithms that analyze a large set of data based on all of the information Ovuline users share about their key health indicators. This is coupled with an analysis of their own personalized health information that comes from quantified self devices such as FitBit or Withings. Users also share their fertility symptoms with us, so we can further analyze that data using our proprietary technology.

All of that information is processed along with clinical guidelines to make accurate and personalized predictions about their fertility cycles. 

It’s a three-step data process: quantified self devices, what women observe about their own symptoms, and what our machine learning analyzes from the millions of data points of women who are also trying to get pregnant. I suppose you could say the big data combined with the small data –personal information — and clinical guidelines are what make up our system.

Ovuline is intended for pre-conception and post-conception.

That’s correct.  We launched our pre-conception – SmartFertility — product in September 2012 . We’re launching our pregnancy module in fall 2013.

What are some the tips and suggestions you give women?

We collect a variety of information from health and wellness data points, including menstrual cycle, cervical fluid, basal body temperature, nutrition, weight, sleep activity, and so on. All of this information — again, coupled with the large sets of data we’re analyzed in the “baby cloud” as I like to call it — allows us to recommend the best time for women to have intercourse to conceive. The women who’re actively using Ovuline conceive three times faster than the national average, two months versus 4-6 months.

Do you have different pricing plans for pre-conception, post-conception, and monitoring?

Although we sell fertility kits and quantified self devices to help our users record their data more accurately, right now we’re really focused on customer and data acquisition. We’re ultimately a data company.  We find and build preparatory algorithms based upon the data that users share with us that improve the user’s experience. 

Right now we don’t have anything – including charging for our service – that’s going to block people from sharing their data with us, because we ultimately think it’s going to be good for us and good for them.  We are exploring opportunities with various partners that will help us monetize, but right now we’re just trying to create amazing user experience and demonstrate the medical efficacy of what we’re doing.

How do you acquire customers?

Word of month is the #1 way we acquire customers. They’re also finding us on the Web because so many women are looking for a solution to this problem and until now there was no way to provide this in-depth level of analysis. The technology didn’t exist, and even as it emerged, this is the first time anyone has applied it to the fertility and pregnancy space. We’ve also been around for long enough that now we’re getting a lot of organic traffic, in addition to app store downloads.

Have you looked at any of the healthcare app store prescription platforms, such as Happtique?

We’re aware of them and exploring partnerships that make sense.

Do you have interesting insights about your data?

Fifty percent of fertility treatments are not needed.  Conceiving is often an issue of timing, as 30 percent of women have irregular cycles. One of the big public health issues around infertility is that it is almost taboo to talk about it. In general, I think any insights related to this space should be shared. We need to talk more about the tools and resources to help women conceive more quickly that don’t cost thousands of dollars.

Is there any other part of your business that you’d like to share?

We’re on the vanguard of supporting the Fitbit and Withings APIs to integrate their data into our database. We’re taking quantified self to the next level and trying to answer the question: what does all of this data mean to me as an individual, and how can I act upon it?

How did you get into this business?

This is my second company.  My first company was a molecular diagnostic company called GoodStart Genetics. GoodStart creates fertility diagnostic so parents can foresee if their children are at risk of being born with a recessive genetic disorder. I started GoodStart in 2008 during my last year of business school. I built GoodStart for four years. I designed the product, launched it nationally, grew the team, raised venture funding, and hired the former CEO of LabCorp to run it. GoodStart is doing incredibly well and continues to grow.

The experience at GoodStart ultimately gave me a pretty deep passion for women’s health, specifically fertility.  It’s a unique place in medicine where you have an acute issue with a positive outcome, so there is positive reinforcement to do an action as opposed to negative reinforcement. It’s incredibly rewarding to able to help people achieve their dreams of starting a family.

 

Interview: Joe Reinardy, Founder, CEO, CenterX

This interview was originally featured on HIStalk.

Joe Reinardy is founder and CEO of CenterX of Madison, WI. 

Tell me about the company. 

CenterX is what we like to call the nation’s next e-prescribing network. We’re building what we speak about internally as e-prescribing 2.0.

When we talk about e-prescribing 2.0, we’re referring  the e-prescribing that has been adopted in the United States over the last 2-4 years. E-prescribing 1.0 is largely the sending of electronic prescription messages from a doctor’s office to a retail pharmacy. If a patient goes to the doctor’s office, the doctor orders a prescription for the patient and says, “Which pharmacy do you want to go pick this prescription up from?” The patient can say, “I want to go to Family Drug Store on Main Street” and the doctor can look up the address electronically and send an electronic copy of that prescription directly to the pharmacy through the Internet rather than writing it on a piece of paper and giving it to the patient and having the patient act as courier of that piece of paper to the pharmacy.

In the last several years, the government has incentivized doctors to adopt e-prescribing. They have done so quite a bit. It’s gone from an insignificant adoption rate in about 2008 to about 44 percent of doctors reporting using e-prescribing in the last year.

CenterX wants to take that adoption and the use of that technology and turn it into something more clinically meaningful. Something that reduces the cost of healthcare and shares relevant information with the various providers of care for a given patient. In the next generation of e-prescribing, what we really want to do is close the feedback loop.

Today the status quo is that doctors send messages to pharmacists, but they don’t get any feedback about whether or not their patients are taking their medications, whether the patients can tolerate the medications, or whether the patients are getting better. The CenterX network simplifies the financial model around e-prescribing and closes that feedback loop. A doctor gets information about, did my patient pick up their medications, are they getting better, or do I need to pick up a phone and call them and ask them why they’re not taking their meds?

Closing the feedback loop is a powerful concept. A lot of companies are trying to innovate at the far end of the loop, the patient end. Companies like AdhereTechScanadu, andProteus, for example. Are you trying to provide the signaling, routing, and transfer infrastructure for all these different kinds of data?

Yes. We would welcome data from anywhere that you can get it. Ultimately what the doctors find useful is knowing exactly what the patient is taking, when, and why or why not. If he can get as close to an actual feedback mechanism that says this pill was ingested by this patient at this time, that would be the ideal situation.

If there are device companies that are coming online and that they’re able to make progress with pharmacies or with health plans and selling their tracking products, those are products that can provide very useful data to us. We act as an aggregation point for a lot of these companies and types of data they create.

Has CenterX exposed APIs to make all of that happen?

Yes. We’ve exposed APIs exposed to receive any kind of data.

You mentioned that you have a different pricing model than Surescripts.

Surescripts and the other companies in the space charge anywhere between $0.25 and $0.30 per prescription. They penalize patients, doctors, and pharmacists per prescription. This is called transaction-based pricing.

Our model is fundamentally different. We charge a flat monthly fee and share the cost among everyone that’s involved: providers, pharmacies, and payers. Prescribers pay just $5 per month for unlimited transactions. We are in many cases two or even three orders of magnitude less expensive than the status quo. Our pricing model encourages participants to use new technology and to use new message types, such as refill requests, cancellations, adherence notifications, and missed notifications.

I can see why pharmacies and payers would be willing to pay, but why would PCPs? 

We bring value to PCPs in two forms. We bring value in immediate release to the doctor’s financial ledger every month as soon as they sign up for our network and start using our network. As soon as they’re paying their monthly subscription fee, we are having a real impact their budget constraints.

Firstly, refill request messages, when a patient has filled their script or already filled their scripts three times and they need a new prescription to extend the treatment of whatever drug they’re on, whatever medication they’re participating in. They need to notify their doctor that they need a new script. That’s what’s called a refill request in the e-prescribing world. Those refill requests have been allowed or permissible on the prescription network or other e-prescribing network for years, but their adoption rate is very low.

Last year, fewer than five percent of refill requests went electronically through an e-prescribing network, as opposed to being delivered via phone or fax. So for a $5 per month subscription to our network, we can get rid of the faxes, we can get rid of the callbacks and get those things electronically into the EMR. The other thing that having an electronic refill request provides that doctor is an accurate and discrete type data list of the medications that they’ve written for this patient in the past and that they’ve taken.

The other problem we help alleviate is prior authorization faxes. We can provide the messaging and routing to expedite that process dramatically. The top six drugs account for 10 percent of all drug costs. Not 6 percent of the drugs — six specific medications. Each of those six medications has what’s called a prior authorization, a paperwork process that takes anywhere from six to 20 hours to complete. You have very expensive meds that are important to patients that the patients can’t start treatment on, for sometimes up to a week if that paperwork process hasn’t been filled out.

We automate their prior authorization process. It’s electronic prior authorization process. It saves hours per week per doctor. For a $5 per month subscription fee, they’re getting rid of their refill faxes and they’re getting rid of the callbacks, the hours that they’ve spent working on prior authorization just to make sure that their patient qualifies for the treatment that they need.

Can providers use CenterX in conjunction with their existing network provider or is it a mutually exclusive switch?

CenterX is not mutually exclusive of SureScripts or any other e-prescribing network. We do not, however, share data or traffic with other networks. We provide a different level and layer of support.

We provide a comprehensive solution that for some clients meets all of their e-prescribing needs. But for most of our clients, we need to grow our network in their communities and demonstrate our capability as an excellent service provider before they can risk single-sourcing their e-prescribing services. Typically, we start working with a new client by finding which e-prescribing services that client is not currently using. In that way, we sit right along side other e-prescribing solutions.

How did you get into this business?

I have a BS in chemical engineering from Michigan Technological University. I worked as an engineer in product design, manufacturing process design, and operations for Kimberly Clark for five years, including brands such as Huggies, Depends, Viva, Scott, and Kleenex.

I wanted something that made me feel more engaged with the customer, an opportunity to do something every day that I thought needed doing. I supported Epic’s first standard implementation of e-prescribing for one of the larger healthcare organizations in the world. Not long after that, I was asked to lead the e-prescribing team as CMS issued a mandate to eliminate computer generated faxes for scripts.

I ran the e-prescribing department at Epic for a number of years. Over that time period, I oversaw the connection of 200 of Epic’s customers to the e-prescribing networks that were available in that timeframe. I saw it was a marketplace that was underserved and was really still struggling just to get a business model off the ground that I thought would be obsolete by the time it was successful. I decided that I would leave that job and started an e-prescribing network.

When I left Epic to start CenterX, I turned to my best friend for help. Our roles have evolved as we find new team members. I wrote the first version of our Web services, but most of what I had written has been revamped by our software architects, who are true computer programmers and mathematicians.

Today I provide technical guidance from an experiential basis. I have years of experience implementing and supporting standards-based interfacing, specifically in e-prescribing. I guide our developers to deliver a robust NCPDP and HL7 standards-based architecture. I’m primarily in charge of strategy. Chris, my business partner, manages the day-to-day operations and is responsible for client relationships.

I often say that I’m an engineer and not an entrepreneur. CenterX is a startup by necessity. I believe that effective change in the e-prescribing industry must come from an independent, organically grown company. I don’t see myself ever leaving CenterX to do the small scale startup thing again. I have developed tremendous respect for the difficulty of entrepreneurship. I enjoy it, but I think e-prescribing has a lot of opportunity for improvement. I could spend my entire career advancing that industry while maintaining that satisfactory sense of direct client engagement that I wanted in 2006.

Tell me about the company. 

We are a privately-held company. We started the company on November 11, 2009 in Wisconsin.

I say “we.” At the time, I was otherwise not employed in any meaningful way and a business partner joined me with the LLC. He had a full-time engineering job working for a large paper company, but it was basically the two of us. We filed the LLC paperwork and worked out some of the details of the business plan. 

We had the technology portions of the business plan worked out, but we didn’t know how to get from idea to reality. It’s pretty tricky to try to negotiate contracts with doctors and pharmacists at the same time who are serving the same patient population.

We spent about a year working on the business plan and writing the first version of the software that runs our Web services. After that first year, we started selling, pitching our product, our solution to a number of perspective clients. We received some very useful feedback that said, “This isn’t quite plug-and-play for us yet, but it’s interesting. Don’t throw it away – we would be interested in talking more.”

At that time, we decided we should go out and get some money. We raised from friends and family somewhere under $200,000. We are now 12 employees. We have not had to go back for any additional funding. We can feed ourselves today.

Any final thoughts? 


There’s a better, cheaper, faster alternative to the e-prescribing monopoly.