Today, FDA held a tweetchat to provide further clarity and answers around its guidance on mobile medical app regulation. The basic takeaway on the guidance (which can be found here) is … it’s good! It’s clear! It’s pro-innovation! That’s great for companies and developers, but doesn’t make for a very exciting Twitter exchange.

Essentially the types of medical apps the FDA intends to regulate are largely unchanged from the draft guidance, but impressively the areas where FDA intends to exercise enforcement discretion – in effect, a hands-off policy – are significantly expanded. As you may have read in my colleague, Brian Reid’s blog post on Sept. 24, big pharma and health care solution providers will, for the most part, be able to develop away with little interference.

Apps that help patients manage their own condition (without providing specific treatment suggestions), organize their personal health information, provide access to information regarding their condition or treatment, help them communicate potential medical conditions to care providers, automate tasks for care providers or enable patients to interact with their personal health records or electronic health records are all fair game.

And FDA certainly had its talking points down, per @FDADeviceInfo: “FDA’s final MobMed guidance supports innovation & protects consumers”. That was a message that got repeated.

FDA did provide a little more color around its philosophy:
• “Enforcement discretion” = FDA is not actively enforcing requirements for manufacturers to register and list with the FDA
• FDA will review apps in a way that balances risks/benefits without creating unnecessary burden for app developers
• The FDA guidance reflects its focused priorities on apps that pose greater risks to patients & is a big de-regulatory action
• Apps that require FDA review will be evaluated according the same risk-based system the agency applies to other medical devices

A brief recap of select Q&A from the tweetchat can be found below. The full tweetchat can be reviewed online at, #FDAapps:

Q. How will FDA be monitoring apps for compliance? Browsing the Apple/Google Play stores?
FDA: Our efforts are focused on education and clarity at this time; we are focusing on clarifying areas that need oversight and looking for voluntary compliance.

Q. Logging and recording data seems to be fine, but what about interpreting data and making care recommendations?
FDA: Apps that meet definition of a medical device but pose little risk to consumers are an area where the FDA is exercising “enforcement discretion”; however, making recommendations that change dosage would raise risk to consumers.

Q. Some dosing apps are simple calculations routinely used in clinical practice. Will FDA exercise enforcement discretion for them?
FDA: Yes – please see appendix B in guidance (pg. 23).

Q. Under what circumstances would FDA choose to alter its enforcement discretion paradigm as explained in the guidance?
FDA: We intend to follow this [enforcement discretion] policy unless we have new info that raises public health risk. If/when we change policies we will follow public processes.

Q. Is the FDA checking apps’ algorithms and/ or checking validation/evaluation of apps?
FDA: It depends on the risk of the device & patient exposure. With regards to functionality, it would be similar to other high risk development.

Q. Is there a time at which you hope to transition to another phase–one of enforcement and action?
FDA: We will allow reasonable time for app developers to be into compliance prior to enforcement actions.

Q. How long does app rev/approval typically take?
FDA: On average, it has taken 67 days for clearance but it depends on the complexity and functionality of the app.

Q. Approximately how many ‘clearances’ of apps are we talking about up till now?
FDA: The FDA has cleared about 100 mobile medical apps over the last 10 years

Other resources:
• For questions about a specific app, please email:
• Health professionals & consumers may submit reports of mobile medical app adverse events or problems to FDA online & by phone @ 1-800-FDA-1088

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Last year, I had the opportunity to participate in a unique educational program for public health leaders through the Office of the National Coordinator for Health Information Technology (ONC) at George Washington University School of Public Health and Health Services. I jumped at the opportunity to study such a dynamic part of the industry, knowing how quickly and drastically changes are happening. The program has given me the core background essential to understanding the intersection of healthcare and technology, which involves health policy, security, privacy, meaningful use, electronic health records and more. I also have had the opportunity to meet and learn from many experts in the field, many of whom will be attending the Health 2.0 Conference this week in San Francisco.

Here are the top things that I learned from my time in the HIT program that are relevant for anyone working in healthcare:

  • The cost of healthcare is not sustainable; we need to make better decisions, need more information from the point of care
  • Meaningful Use Stage 1 put us on the up ramp; healthcare organizations are not doing meaningful use for money, but for improvement in patient care
  • Technology accelerates advancements in healthcare, but has to be done right at the right time
  • Only until we start engaging the patient will we see a difference in healthcare
  • Patients are ready for the new era of healthcare, physicians are starting to hear things like “it’s in my chart” or “can’t you just scan me”
  • While connected care is critical, as physicians share charts and health information exchange exists, more competition will transpire to keep and maintain patients
  • There are still a lot of skeptics regarding electronic health records, so the benefits need to be continuously reinforced and issues managed and proactively communicated (e.g., backup plans for security breaches, power outages)
  • Consolidations, mergers and partnerships will occur: smaller healthcare groups will align with larger ones because of the high capital investments associated with reform and the approximately 16,000 EHR vendors will merge toward the end of next year to about 12,000
  • Analytics, including physician benchmarking, is leading the evolution of value based medicine
  • Healthcare organizations must be nimble and flexible given new, fluid and dynamic marketplace

I have also experienced the healthcare revolution firsthand through working with our clients here at WCG. We work with some of the top leaders of innovation in the industry, innovating and enabling change every day via their wireless health solutions, mobile health and fitness apps, care collaboration networks and more. As a testament to the vast changes in the healthcare industry and necessity to innovate in order to stay relevant, WCG has since launched a new specialized practice, Healthcare Technology & Transformation, to help us guide our clients in the ever-changing healthcare industry. Focused on all aspects of healthcare technology, our integrated approach allows us to utilize all areas of the communications spectrum from traditional public relations to strategic influencer identification and analysis.

This week at Health 2.0, follow the conversation via #health2con. I’ll be there meeting and greeting with old and new friends, listening to esteemed speakers talk about groundbreaking topics and watching the latest product demos. It’s bound to be an exciting conference.

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#MDigitalLife is a WCG program designed to learn from and to showcase physicians who are blazing new trails in the digital world – changing the way that medicine is practiced and better health is realized.  You can find previous posts here.

“I do interact with patients online (though not my own, of course) … I like to hear the stories about health issues they’re facing, and to follow their journeys … It helps me to understand what patients expect – or at least hope for – from their doctors.”

Danielle Jones, M4 (Medical Student), 4th Year

We’ve focused a great deal in this series on the role that physicians play in educating their patients.  But Danielle Jones, a 4th year medical student at Texas Tech, had a lot more to say about how patients have been educating her. “We’re all patients at some point in our lives – we’re not just doctors and med students.”

Danielle was an early adopter of twitter (she opened an account at the advice of her husband, who works in technology and had picked up quickly on the potential of the tool).  She’s always been passionate about fertility issues, and soon realized that Twitter was used actively by patients who were going through IVF treatments.  As she listened to their conversations, she began to understand their experience more clearly … and then to extrapolate how valuable that understanding could be as a physician.

Our twitter-using readers will know that it can be a place that’s very much about talking – often to the point of self-aggrandizing.  But Danielle recognized that it was an incredible place to listen and understand – and to engage with others. “I don’t use my twitter account solely for medicine.  I like to use it for people who interact.  It’s not necessarily about people who write a great blog or are skilled marketers – it’s about people who are willing to have an engaging conversation.”

In Danielle’s case, that engagement might be about DIY home repairs, or design, or furniture restoration. But more and more often, it is about medicine – and the changing relationship between doctors and patients.

“Patients aren’t going to come into the exam room and tell you that they’re frustrated because you’re 30 minutes late and will only spend 5 minutes with them.  But they’ll tell twitter. Sometimes we get so involved with the medical aspect of being doctors, we forget that there was once this whole world that we didn’t understand.  The doctor’s experience is an abstraction to a patient – they don’t know what’s going on behind the scenes.  It’s a good reminder of what things were like for us before we started studying medicine.”

Danielle Jones

Twitter also became a place where she could learn from other physicians who were exploring the potential of social media as a mechanism for becoming more effective doctors.  She’s had a lot of wonderful influences that started on twitter, including (but definitely not limited to) the following:

  • Bryan Vartabedian and Wendy Sue Swanson – “They are two of my favorites.  They’re really active and engaging and share great information.”
  • Daniel Kraft – “He’s so sharp – I’ve had an opportunity to meet him, and came away really impressed.”
  • Natasha Burgert – “She shares really great information – but she’s also so down-to-earth and genuine that people really respond to her.  That’s inspiring.”
  • Nick Bennett – “He’s done some guest-blogging on Mind on Med (he did a series about Medical Education in other countries). Some of his articles on my blog have gotten more traffic than mine, and he’s always incredibly responsive to comments and questions.”
  • Natalie Silvy – “She’s a med student in the UK who co-founded a twitter-based journal club, and has written about medical education on my blog.”
  • Brittany Chan – “Brittany and I go to medical school together, and she’s my partner in crime in terms of advocating for social media.”

When Danielle started medical school, she found that there was so much reading and studying that it didn’t provide many outlets for creativity.  As a result, she decided to start blogging.  Her blog, Mind on Med, was never designed to be a “marketing piece.”  It was always about having a place to express herself – on almost any subject.  But it picked up a quick following, and it wasn’t long before people started to take an interest in her perspective.  She was selected from a pool of applicants to be a reviewer for Iltifat Hussain‘s iMedicalApps.  And Doximity, an emergent physician’s community – asked her to join them as an advisor relative to reaching medical students.  That led to an invitation to join a Doximity-sponsored conference in California – and to sit on a panel with none other than Wendy Sue Swanson and Bryan Vartabedian.  “I felt about 2 inches tall sitting next to these two people who’d had such a great influence on me.  It was an incredible honor to be able to spend that time with them.”

Danielle has consciously avoided promoting her blog among her fellow med students – though some of them have mentioned to her that they read it.  And nearly all of them have been positive about the notoriety it’s gained her with iMedicalApps and Doximity.  But it also caused her to gain the notice of the medical school administration.  When Danielle started medical school, the only mentions of social media were cautionary tales – “Don’t share patient information!  You could go to jail or get kicked out of school!”  That differs pretty widely from her own viewpoint, which she articulated brilliantly here, in her post entitled, “What Medical School Doesn’t Teach Us.”

The Dean of the medical school knew that there was more to it than that – and asked for Danielle and Brittany to join an advisory board on social networking. The board is working on creating a social-media-friendly set of guidelines for medical students, and hopes eventually to have some curriculum elements adapted to be more even-handed in portraying the potential of social media. That role prompted a sponsored trip to the Stanford MedicineX conference (the brainchild of Larry Chu, MD being held this year from September 28-30th in Palo Alto).  Danielle and Brittany are hoping to be able to come back to school with some great new ideas and case studies that will move the mission forward.

With all of the well-received recognition Danielle has received for her work in social media, it may not surprise you that she plans to continue it through her residency, internship and into professional practice. But it has surprised a lot of people in the medical community.  As I’ve come to understand it, the process for applying for residency is something like rushing a sorority at a Texas state college – on steroids#.  And the conventional wisdom is that you shouldn’t do anything that’d rock the boat for you during the application process.  Many med students are counseled to shut down all of their social media accounts until the process is complete, lest something that they’ve done might rub an interviewer the wrong way.

When one of her fellow students asked Danielle when she planned to shut down her blog prior to the residency application process, she was shocked.  And not a little bit offended. That emotion prompted her to write a piece called, “5 Reasons Danielle Jones and Mind on Med Won’t Disappear during Interviews.”  That post got a lot of attention in the medical community – especially after it was picked up by the leading blog in medicine – Kevin Pho’s KevinMD.

It’s good to know that conventional wisdom isn’t going to hold Danielle back.  Her view of the doctor-patient relationship may just be the template for the future. As the gulf between patients and physicians has done nothing but expand for the last 30 years, Danielle is bridging it – though she’d never claim that distinction.  Not everyone involved in infertility discussions online welcomes a medical student into their midst.  But most are really pleased that a future physician would care enough about what they’re going through to join them.  Danielle has had a chance to cry with women who’ve lost a pregnancy, celebrate with those who’ve become moms, and encourage those who’ve had to endure setbacks and disappointments along the way.

 “I don’t know that I really thought about how beneficial it’d be to connect with these folks online.  But once I started interacting with them, I was just blown away.  Infertility is one of those things that just takes over a person’s life. They need to be able to talk about it with people who care … and it’s so hard to really hard to understand someone’s journey until you’ve gone through it with them. These people share so much of their lives with one another, and I’m incredibly grateful that they’ve allowed me to share that experience with them.”

Would you want Danielle Jones to be your doctor?  I would.

You can keep up with Danielle here:

  • Blog: – I haven’t mentioned it yet, but one of the reasons that Danielle’s blog has achieved such popularity is that it’s both thoughtful and funny as hell.  Consider it a must-read.
  • Twitter: @DanielleNJones
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#MDigitalLife is a WCG program designed to learn from and to showcase physicians who are blazing new trails in the digital world – changing the way that medicine is practiced and better health is realized.  You can find previous posts here.

“The use of mobile and social technology have come into prominence at a wonderful point in time.  They’re allowing us as physicians to connect with minority populations who have already adopted those technologies at a significantly higher rate than the average American.  It’s my hope that we can leverage the confluence of those trends to leapfrog minority families – for the first time – into a position of empowerment relative to their health.”

Ivor Horn, MD – Children’s National Medical Center

Ivor Horn is a pediatrician at the Children’s National Medical Center in Washington, DC.  That institution, for those who aren’t familiar with it, serves kids and families in our nation’s capitol, many of whom are members of traditionally underserved populations such as black americans and latino americans.

Children’s National cares for patients through more than 360,000 visits each year and is the regional referral center for pediatric emergency, trauma, cancer, cardiac, and critical care as well as neonatology, orthopaedic surgery, neurology, and neurosurgery.  Children’s National is ranked among the best pediatric hospitals in the United States by U.S. News & World Report and The Leapfrog Group.

It also serves as a research center of note for doctors and other scientists who are working to address the health needs of these populations. While Dr. Horn started her career as a full-time practitioner, her role has now evolved to about 90% research.

“I love seeing patients, and I’d never give that up. I know that I can make a difference through that interaction with a kid and their parents, but I wanted to see how I could multiply that influence beyond the 1×1 interaction.”

Ivor Horn, MD

Dr. Horn believes that the exam room is the right place to help families work through solving their specific health issues.  But there are also system health issues that can’t really be addressed from the exam room – and that’s where a lot of her research is focused.  Over the last several years there has been a significant push in the US to ensure that physicians are regularly applying “evidence-based medicine” – in other words, that they’re diagnosing and treating patients based primarily on proven methods. Dr. Horn is a strong advocate for the consistent application of those clinical guidelines, but she’s also identified that they rarely go far enough  She sees that the communication that wraps around that evidence-based medicine is significantly more important for minority populations – both for doctors and patients.

Many doctors have a hard time translating clinical messaging into lay terms that are easily understood and actionable by their patients (some studies have shown that the average patient understands less than 50% of what their doctor tells them).  For a physician to learn to communicate with minority populations is particularly difficult – and its not just because of language or education issues.  There are cultural norms around health in minority populations that most doctors are unfamiliar with, which can further complicate the communication process.

A significant amount of Dr. Horn’s work is focused on finding ways to increase the impactfulness of physicians’ communication with their patients.  Dr. Horn wants give physicians and patients the tools and techniques they need in order to “use the 15 minutes they have together to EMPOWER and ENABLE patients in the greatest way possible – to increase the odds that patients will be willing and able to follow treatment protocols, and ultimately to improve their health outcomes.”

A good example of that work is in progress now, in the form of a protocol designed to help kids with asthma – and their families – to keep that asthma under control, and avoid acute attacks that put a child’s health at risk and force an emergency room visit.  The program was developed as an exam-room process that enables patients’ families to actively question their doctor about the kind of care their child needs in order to avoid asthma attacks.

One of the common problems in minority populations is that they don’t necessarily think that they have the right to have all of their questions answered by their treating physician.  Dr. Horn’s program tells them – and teaches them how – to effectively do so.  She always tells her patients – explicitly – no matter where I am, PLEASE ASK ME!!  She is their primary care doctor and therefore their advocate.  When she refers patients to specialists she tells them the same, and lets them know that it is their right and their obligation to ensure that they fully understand their doctors diagnosis and treatment.

It turns out that asthma serves as a great example of how this scenario plays out in real life.  In the hospital they have a clinic in the ER for kids who are at risk for asthma issues.  Those kids are admitted because their asthma frequently gets out of control.  At the clinic they get intensive education about how to manage asthma (environmental, social, and medical).  And a big part of that program is helping patients’ families to work with their primary care providers (PCPs) to continually manage their asthma so that they STAY out of the ER.  The problem was that their PCPs weren’t necessarily equipped to work with them on that kind of proactive management.  The PCP would say “your asthma is under control – why are you here?” And they’d say “because I’m am supposed to be!”  Basically, Dr. Horn’s patients weren’t always getting what they needed from the PCP.  So her program is about treating asthma – but mostly about arming parents to communicate effectively with PCPs.  Her patients learn things like:

  • What are the components of a healthcare visit?
  • What do they need to tell their doctors?
  • What do they need to ask?
  • What do they need to walk out the door with?

After completing the asthma intervention, she and her research partners surveyed the group of families who’d participated.  When the families were asked what had been the most valuable aspects of the program, they got responses like,  “It gave me the ability to ask questions – I didn’t know I could.”  “I knew I couldn’t give my child that medicine because of my work schedule.”  “I didn’t know that I could let Grandma pick up the medicine.”  All of those are things that, once identified, can easily be worked around.

The problem was that the program was successful in the short term, but that it was hard to sustain.  People were tending to drift back into their old habits.  Now, their challenge is to take the program and make it both evidence-based AND sustainable.  Dr. Horn believes that the answer may lie with a mobile intervention – perhaps leveraging SMS text messaging.  A mobile intervention would allow patients to access the information they need at the right time (i.e., when they’re about to visit their primary care doctor) – but also allow them to call it up whenever they need it, easily.  They’ll get refresher reminders over a period of time – and it guides them towards the next visit.

Hopefully the mobile solution will prove to be effective enough in sustaining successful treatment that it will stick around – and have a side benefit as well.  If it works, it’ll be able to take Dr. Horn’s research and techniques and allow them to scale to the point that they’re available for pediatric asthma patients all over the country.

There is tremendous momentum building around eactly this kind of mobile health innovation.  Dr. Horn wants to be sure that the companies and organizations involved don’t forget underserved populations as they’re designing and testing their inventions – and encourages such companies to partner with those underserved populations and the doctors who serve them.  That’s not necessarily easy to do directly today, but Dr. Horn suggested that interested companies should start with the “safety net” organizations to see how they could engage to determine how their solution could be applied to a specific population.

Organizations like the  National Medical Association, the Association of Black Cardiologists and the Hispanic Medical Association are focused on black and latino populations, and can often provide great resources and insights in terms of taking things forward. Medical schools are also great partners for that kind of innovation; Childrens National frequently partners with Howard Medical School and works on child health disparities funded through NIH.

I came to know Dr. Horn through twitter, while she was visiting Austin for the SxSW interactive festival last year.  Just as we saw recenty from Wendy Sue Swanson, the way Dr. Horn uses social media to communicate with a broader population came through traditional media.  Dr. Horn found that she was doing interviews in local media on a relatively recent basis, but wanted to find a way to access that same broad population on a more regular and controlled basis.

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She thought about starting her own blog, but decided that it’d make more sense to start leveraging a social property that already had a foothold in her desired audience group – and would be regularly maintained in the event that she wasn’t able to keep a frequent enough publication schedule.  As it happens, she had a friend who already had a blog for parents of color – Denene Millner’s My Brown Baby.

As is fitting for a scientific researcher, Dr. Horn decided to attack blogging systematically, and conduct it as a kind of experiment.  She and Ms. Millner agreed that she would blog monthly for six months.  Before, during and after the experiment, they measured the conversation on and around the blog.  Ms. Millner had already provided a forum that had proved to be effective in engaging families in healthcare and childhood development, and was interested in adding more detailed medical information – effectively raising the level of conversation from a purely “lifestyle” conversation to a true health conversation.  Dr. Horn presented the results of that study at last month’s National Conference on Health Communication, Marketing, and Media (Use of Social Media for Engaging Communities of Color In Child Health Dialogue). Dr. Horn feels confident that they measurably achieved their goal – in fact, the blog was nominated as a Best Health and Wellness blog in 2011.   She’ll be presenting it again this month at the Medicine 2.0 Conference in Boston.

The key learning from that experience for Dr. Horn was that when a physician comes into the right conversations online, it can make a measurable difference in parenting.  That positive experience proved to be a launchpad for Dr. Horn to expand more deeply into social media, and Twitter was the next logical step for her.  Blogging can take a LOT of effort and time (which as an academic she doesn’t have in abundance). Dr. Horn joined Twitter looking for the same target population she’d accessed through Ms. Millner’s blog (minority parents). She’s been successful in doing so, but also managed to find another community that she wasn’t necessarily expecting: There is a small (but active and growing) group of folks on Twitter who are focused on finding new ways to address the needs of underserved populations.  Not surprisingly, she mentioned how much she appreciates the work and approach of Andre Blackman (Pulse + Signal; creator of the Fast Forward film festival for health innovation) and  Alisa Hughley of enBloomMedia, who’s focused on transplants/organ donorship in minority populations.

Dr. Horn’s vision for the power of digital and social media to help reduce some of the health disparities in underserved communities is an inspiring and powerful one – and one well worth following.  You can keep up with them through Dr. Horn’s twitter account – and also by following these hashtags: #meded #hcsm #minorityhealth #disparities

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Here’s the secret to succeeding in business. Ready? First, make a good product that works well and is delivered efficiently. Second, never forget how important your customers are, or you’ll lose them. Repeat.

It works for almost every industry. A lot of people think Coke tastes great. Why else drink it? Exxon refines crude oil into gasoline. It makes your car run. Sell. Repeat.

But when it comes to healthcare and its delivery, the system isn’t working nearly as well as it could, the products offered don’t provide the results you deserve, and customers – patients – don’t always receive the benefits they should. This was a theme that really stuck for me as I listened to some extremely smart and accomplished people speak this week at TEDMED.

Despite this inconsistent, often frustrating system, there’s a lot of hope and progress being made to fix it, with evidence-based medicine, the effective use of data and mutual accountability leading the way at putting patients first.

Here’s a look at what leaders of the CDC and FDA, the executive health editor at Reuters, President Obama’s chief technology officer and a cancer theoretician and mathematician had to say about improving patient health. See what I mean about extremely smart and accomplished people?

Dr. Thomas Frieden (Director, Centers for Disease Control and Prevention)
In the early 90s, tuberculosis ran rampant in New York City, spreading through hospitals, homeless shelters and resisting multi-drug treatment. It was so bad, Dr. Frieden said, that physicians didn’t want to complete their residencies in New York for fear of contracting tuberculosis themselves.

Dr. Frieden had initial success in bringing tuberculosis under control. But at a chance meeting with a physician who had contracted tuberculosis in a concentration camp during World War II, Dr. Frieden was asked an amazingly simple question that proved transformative: “How many patients did you cure?” Dr. Frieden, “terribly ashamed”, didn’t know the answer.

He began a process called cohort reviews. Traveling to every part of the city, his team reviewed patients one by one until they knew exactly how many had been cured. “Data and information isn’t just statistics, it’s what is locally relevant,” Dr. Frieden said. And if the data isn’t being used with the intention of making patients the VIPs, it’s not being used well. “If you’re not measuring with brutal honesty, you won’t succeed.”

There was one other point from Dr. Frieden’s presentation that’s worth noting. Advertising and media outreach works: Last month, the CDC launched a hard-hitting campaign, Tips from Former Smokers, on what tobacco really does to people. The reason? Media campaigns are “an evidence-based strategy to educate the public regarding the harms of tobacco use.” Did the evidence hold up? You bet. Dr. Frieden says calls to quit lines doubled in the first month.

Dr. Ivan Oransky, Executive Editor of Reuters Health
Dr. Oransky used a simple, and timely, story to demonstrate the situation Americans face with their healthcare. Billy Beane, of Moneyball fame, was himself, albeit shortly, a major league baseball player. Scouts all thought he’d succeed but their predictions were wrong. The healthcare system, Dr. Oransky argues, is as bad at predicting what will happen to people as scouts were at predicting that Billy Beane wouldn’t make it as a ball player. For the healthcare system to work, and work well, its delivery and service must improve. A system where patients feel they’ve received bad care unless they’ve been diagnosed or prescribed medicine doesn’t create good service. Dr. Oransky said:
“We have a system where if you build it, they will come. Billy Beane learned that it wasn’t swinging for the fences, it was watching for the guys who like to walk. We need to figure out, is that a good pitch or should we let it go by and not swing at everything?”

Todd Park, U.S. Chief Technology Officer
Dr. Park didn’t have any gizmos or gadgets. He was just a self-described “fanboy” who said something pretty remarkable is happening in Cincinnati, Ohio. It’s not the chili.

By most measures, Cincinnati was average when it came to healthcare delivery. The city decided it wasn’t content with average. So a few years ago, stakeholders representing many constituencies got together regularly to understand health status in their community and the performance of the healthcare delivery system. They started small, with flu coverage, at which they were, again, “resoundingly average.”

To fix it, first these stakeholders developed a set of common performance metrics and an ongoing measurement system to help achieve goals. Second, they realigned how healthcare is paid for. Insurers and providers wanted to pay for value. Doctors were offered extra incentives and other resources to help them coordinate care more proactively and accelerated deployment of electronic health records and educated clinicians on how to use these new tools. Finally, they put patients at the center. They published a website that gave them much better information on flu. Treatment improved. It’s also working for diabetes, where between 2010-2011, the cohort of patients receiving perfect diabetes care improved greatly.

Dr. Jacob Scott, radiation oncologist and cancer theoretician, Moffit Cancer Center
Dr. Scott thinks of himself as a long-range scout searching the world of biology he’s seen and what is limiting our success in healthcare. If that sounds different than many doctors you know, it’s because Dr. Scott has had a unique experience. He studied physics, served in the U.S. Navy on a nuclear submarine and while studying medicine, decided he should also study mathematics at Oxford University.

Much of what limits success in healthcare, Dr. Scott argues, is medical school. When he arrived, medical school was “like a backstage pass to everything cool about being a human being.” However, medical school, which Dr. Scott says rewards medical students based only on GPA and MCAT scores, is not doing enough to encourage creative thinking and unique partnerships that can look at healthcare’s biggest problems, especially in oncology. Instead, medical school needs to remind students that it’s not the information they leave medical school with, but the ability to face problems critically and step out of their comfort zone, that will make the biggest difference in medicine.

Dr. Peggy Hamburg, Commissioner, U.S. FDA, and Larry Brilliant, president and CEO, Skoll Global Threats Fund
Mr. Brilliant interviewed Dr. Hamburg on a range of issues that are front and center in healthcare right now. Here are some excerpts from the conversation:

Balancing the need for innovation with regulation and safety: Dr. Hamburg said that smart regulation matters if you want to translate science and technology into the products people need. Smart regulation improves the quality and utility of a product while ensuring there’s trust and confidence in it from patients and physicians. She added that a lot of people at the FDA don’t understand the process of innovation and running a business. By reaching out and talking to CEOs and entrepreneurs, the FDA has learned a lot.

On speeding the approval of drugs and devices: Drugs and devices are very different, Dr. Hamburg said. On the drug side, the FDA leads the world in terms of first to market on a majority of drugs and in the time of that review process. Devices are more complicated. FDA is faster the majority of the time compared to European colleagues but slower for pre-market approvals.

The impact of globalization on drug safety: As drug development has moved offshore, so have safety trials, and the challenges of globalization are immense, Dr. Hamburg said. Of the drugs taken in the U.S.,
40 percent are manufactured in another country and 80 percent of the ingredients are manufactured elsewhere. That’s just on drug side.

On drug shortages: Dr. Hamburg said this is a problem that’s increased in recent years in a way that worries all of us. The biggest shortage has been with sterile injectable drugs, many of which are generics or older drugs. They are hard to make and the manufacturing equipment is old. Economic forces are also at play. The FDA is working to learn about shortages much, much earlier, she said, and collaborates with manufacturers to make sure the drug remains available. It also means identifying other manufacturers who can scale up to meet a shortage and those who could make the drug but aren’t, or go overseas and work for an equivalent drug that isn’t approved but could.

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Scene from the ACR 2011 Tweetup. Photo by Lothar M. Kirsch (@Rheumatologe)

The first crocuses are poking up, a sign that the spring medical meeting season is upon up. This week, it was Conference on Retroviruses and Opportunistic Infections, and colleagues are preparing for everything from the American College of Cardiology meeting in a few weeks, to the American Society for Clinical Oncology and American Diabetes Association confabs in June. I haven’t seen the agenda for everything yet, but I’m confident that all of them will come up short in one profound way: patients will be underrepresented.

This isn’t new. Medical conferences in have long been tilted toward experts — those with data or experience. And attendees have long been rank-and-file health care providers who want to stay on the cutting edge of their field. In the old, top-down system, having patients at these confabs was superfluous. But those days are over, driven by three trends that are likely to reshape the health care system:

  1. The empowered e-patient is demanding the same information available to professionals. And if that information is available at medical meetings, that’s where the patients should be.
  2. Increasingly, information is transmitted not only from provider to patient, but patient-to-patient. It’s no longer a safe assumption to believe that information only travels in one direction.
  3. The patient experience is increasingly important in the treatment process. The way quality of life impacts benefit-risk calculations is highly personal, making an open discussion with patients crucial to understanding diagnosis and treatment.

These trends aren’t entirely hidden, and yet patients are still hard to find at meetings. Part of this is cost. Part of this is logistics. And part of this is the challenge that comes with overcoming the inertia of the existing presentation-first mentality. But there are enormous  benefits to be reaped for groups that can overcome these obstacles.

Last fall, I attended the American College of Rheumatology meeting, and I participated in an informal “tweetup” during the sessions. A group of individuals: half patients, half providers, found a quiet place in Chicago’s McCormick center and had a robust dialogue about how patients view medical advances and what new forms of communication might create bridges between professionals and information-hungry patients. Much of what I took in during the conference has already left me, but not the experience of that tweetup.

(For more on patients at medical meetings in general, and ACR in particular, please see Kelly Young’s recent publication in the Journal of Participatory Medicine.)

The goal, then, is to recreate that experience, on larger scales and at more venues. Conference organizers can play a part by engineering patient interaction into the program (though official, promoted patient activities). And all of us need to think through ways of reducing the cost burden that prevents patients for attending these kind of events, such as discounted rates and more aggressive sponsorship programs.

The result would be stronger patient communities, improved communication and — in the end — better medicine.

(Note: This is not an issue that’s exclusive to medical conferences. Patient voices need to be heard more often in as many diverse forums as possible. The annual SXSW Interactive conference kicks off tomorrow, complete with a health track. Yet patients are under-represented there, too. Is this a subtle plug for the patient-heavy panel I’m moderating on Sunday at 9:30 a.m., with Alicia Staley, Allison Blass, Kerri Sparling and Michele Polz? You bet. See you there.)

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#MDigitalLife is a WCG program designed to learn from and to showcase physicians who are blazing new trails in the digital world – changing the way that medicine is practiced and better health is realized.  You can find previous posts here.

“The healthcare organizations who are going to do the best are the ones who can help and encourage their doctors to truly be a part of the community – to help make them human to the patients in the area.  Those are the doctors patients will want to go to for the long term.”

Jordan Grumet, MD

After completing his undergraduate degree at the University of Michigan, getting his MD from Northwestern and completing his residency in primary care at Washington University, Jordan Grumet was convinced that he wanted to be a hospitalist.

That didn’t fit properly, so he went into primary care with a large group at Northwestern.  But that wasn’t quite right either.  The sheer size of the group made it hard for him to really practice in a way that felt comfortable for him.  So he joined a sole-practitioner in Highland Park, Illinois in 2007 and has been there ever since – now as a partner.  The end.

Except that it’s not.  It’s true that ALL doctors are people – which means that they’re all unique.  But how many physician poets do you know?  How about physician-poet-fine art dealers?  Jordan is all those things.  In addition to the work on his blog, In My Humble Opinion, Jordan is working on his first poetry book.  In fact, Jordan’s journey into social media (and hence into MDigitalLife) started with a side project.

Several years ago, Jordan ran a web site selling fine art and figured that he’d need to start blogging in order to drive attention and subsequent sales.  It wasn’t until 2005 that he came to the realization that the social media skils he’d developed could also be applied to his real passion – medicine and health.  When you read Jordan’s blog, you’ll immediately notice some differences from most medical blogs.

“The remainder of the night was a blur. I couldn’t sleep because I was busy with other patients. The man’s wife and family came and went. It wasn’t till the next morning that the phone calls started to roll in.

Apparently my patient had three daughters from a previous marriage who were unaware of what happened. I took three calls that morning. I told three young women that they had lost their father. I waited patiently as they broke down. As I listened to their sobbing, I remembered what it felt like to lose my father. Each call lasted less then five minutes and left an indelible mark on my soul. I had never experienced a grief so pure and innocent as those young women’s. I will always feel responsible.

And this is what the chief meant by being “hurt.” If you practice medicine long enough, you will make mistakes. You will accidentally harm people. You will work long hours and deal with the most primitive human emotions. At some point you either learn to sublimate, learn to move on, or get crushed.

– Jordan Grumet, MD – excerpted from For My Son

A big part of Jordan’s blogging is for self-expression and his own development as a writer.  But it serves two other important purposes.

The first is to help his patients to get to know him in a way that they could never do in a short appointment (or even in a series of short appointments).  “Patients have to bare their souls to their doctors,” he says, “but unless doctors can find some way to equalize that relationship, they’ll never truly reach most patients.”  As a primary care doctor, Jordan describes one of his chief roles is to be “the ultimate detective.”  People come in with undifferentiated problems and symptoms, and you often have to work with them for months – or even years – to define their disease paradigm.  50% of any health problem has nothing to do with physiology – it’s about the psychiatric and emotional issues that come with it.  And the more his patients know and trust him (to the point of being willing to tell him when they disagree, or when they’re not adhering to their treatment), the better he is at helping them to get better.

“When my patients see that I care, it forms an incredible bond.  When they know that someone really understands, they just do better.”

Jordan Grumet, MD

The other reason for Jordan to do what he does is that he believes doctors have had their voice silenced by the system over the years – and that they need to regain it.  They’ve been painted as BMW-driving villains by the media and other players in the health system – and there’s nobody to tell their side of the story.  Through his writing, Jordan is laying down an example for other doctors – and in a small way, beginning to redress that balance.

“Doctors are human beings – and they have more in common with you than you think.”

– Jordan Grumet, MD

I, for one, couldn’t agree more … and I hope that doctors, patients, and people who simply appreciate good writing will visit (and subscribe to, and share) In My Humble Opinion.


A sample from Jordan’s physician reading list:

Westby Fisher –!/doctorwes

Bryan Vartabedian –!/doctor_v

Kevin Pho –!/kevinmd

PDara –!/jedipd

Jackie Fox:!/jackiefox12

Ramona Bates –!/rlbates

John Mandrola –!/drjohnm

Linda Pourmassina –!/lindap_md


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