HealthBlawg :: David Harlow's Health Care Law Blog https://healthblawg.com ** We've Moved! Update your Reader Now. * This feed has moved to: http://feeds.healthblawg.com/healthblawg Update your reader now with this changed subscription address to get your latest updates from us. * http://feeds.healthblawg.com/healthblawg Fri, 18 Jan 2019 21:32:56 +0000 en-US hourly 1 David Harlow David Harlow Creative Commons Attribution-Share Alike 3.0 no David Harlow's Health Care Law Blog David Harlow's Health Care Law Blog https://healthblawg.com/2019/01/rfi-change-hipaa.html How would you like to change HIPAA? http://feeds.healthblawg.com/~/592415440/_/healthblawg~How-would-you-like-to-change-HIPAA.html http://feeds.healthblawg.com/~/592415440/_/healthblawg~How-would-you-like-to-change-HIPAA.html#comments Wed, 16 Jan 2019 17:48:17 +0000 https://healthblawg.com/?p=5893

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]]> http://feeds.healthblawg.com/~/592415440/_/healthblawg~How-would-you-like-to-change-HIPAA.html/feed 2 Physicians,Hospitals,Compliance,Healthcare Innovation,Accountable Care Organization,Anti-Kickback Statute,Fraud and Abuse,HIT,Health care policy,Health Law,HHS,Value Based Purchasing,Pay for performance,Privacy,Security,HIPAA HIPAA, everyone's favorite scapegoat for all (OK, most) of the ills of the modern healthcare-industrial complex, is perpetually called out as being in dire need of a rewrite. Well, that moment has arrived (maybe). There's an RFI out right now, published as part of the federales' “Regulatory Sprint to Coordinated Care,” announced by HHS Secretary Alex Azar in mid-2018. (Remember, this is the federal government, so getting almost halfway through the throat-clearing phase of fleshing out an idea in about six months or so really is a sprint.) Hey, coordinated care is a good idea. We can all agree on that. The first RFI to issue was the one seeking input on the regulations implementing the Stark law and the federal anti-kickback statute (See: Stark and AKS RFI and public comments). The HIPAA RFI came next. (Comments are due February 12, 2019.) The final piece of this trifecta is the privacy rule applicable to substance abuse service providers, aka 42 CFR Part 2. Recently, Part 2 got a pretty significant overhaul, but many folks have been hoping that Part 2 and HIPAA could be better harmonized. (Speaking from personal experience, the regulated community tends to look at those of us steeped in this stuff like we have two heads when we explain how Part 2 is different from HIPAA, and how records with respect to the same patient must be handled differently due to this distinction.) Sprinting towards coordinated care sounds like something we should all encourage, but it is important to keep in mind that the current Administration is particularly interested in deregulation, and that is not always the sort of thing that can go well for all parts of the extremely heterogeneous regulated community, or for those whoa re supposed to be protected by these regulations (patients, i.e., all of us) particularly when deregulation is being carried out on a piecemeal basis, at the regulatory level. It is also important to keep in mind that legislation forms the boundaries of the playing field, so to speak — a regulatory sprint to coordinated care can't run down the sidelines and across the parking lot even if that would let us get to an ideal future state sooner and more efficiently. A digression: As the health wonks and policy nerds reading this are already aware, HIPAA is a horse of a different color. The original HIPAA regulations were drafted by HHS in the absence of any particular statutory framework. In the 1996 HIPAA statute (which covered a lot of other ground), Congress gave itself one year to legislate standards for health data privacy and security, and decreed that if it were to fail to meet that deadline, HHS would have to create regulations from whole cloth. And that's what happened: Congress did not act, and HHS went to town on its own. (The regs were finalized in 2003.) Then, in 2009, as part of the Recovery Act, Congress passed the HITECH Act, one title of which is a statute that amended the HIPAA regulations — regulations that were drafted in the absence of a specific statute. The reason I bring up this legal-historical anomaly is to point out that while ordinarily a federal agency issuing an RFI seeking input on potential changes to its regulations is limited by the underlying statute, in this case much of the regulation has no underlying statute, so the agency will ultimately have greater flexibility. This is both a good thing and a bad thing: On the one hand, HHS can be more creative in revising HIPAA regulations in order to advance its policy agenda, and on the other hand … HHS can be more creative in revising HIPAA regulations in order to advance its policy agenda. The RFI lists over 50 specific questions on which the agency is seeking feedback, plus a catch-all “anything else?” question, but it is first and foremost a request for information regarding revisions to the HIPAA regulations that may be needed to promote care coordination. (“Encouraging ... HIPAA, everyone's favorite scapegoat for all (OK, most) of the ills of the modern healthcare-industrial complex, is perpetually called out as being in dire need of a rewrite. Well, that moment has arrived (maybe). There's an RFI out right now, ... David Harlow https://healthblawg.com/2019/01/all-of-us.html Talking about the NIH “All of Us” Program with Dara Richardson-Heron MD, Chief Engagement Officer – Harlow On Healthcare http://feeds.healthblawg.com/~/590938752/_/healthblawg~Talking-about-the-NIH-All-of-Us-Program-with-Dara-RichardsonHeron-MD-Chief-Engagement-Officer-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/590938752/_/healthblawg~Talking-about-the-NIH-All-of-Us-Program-with-Dara-RichardsonHeron-MD-Chief-Engagement-Officer-Harlow-On-Healthcare.html#comments Mon, 07 Jan 2019 14:49:35 +0000 https://healthblawg.com/?p=5872

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]]> http://feeds.healthblawg.com/~/590938752/_/healthblawg~Talking-about-the-NIH-All-of-Us-Program-with-Dara-RichardsonHeron-MD-Chief-Engagement-Officer-Harlow-On-Healthcare.html/feed 1 Interview,Population Health,Audio,Digital Health,Harlow on Healthcare,Participatory Medicine,Healthcare Innovation,Precision Medicine,Machine Learning,EHR,Health care policy,Health Law,Open Data,Chronic care,Open Government,Podcast I recently spoke with Dara Richardson-Heron M.D., chief engagement officer of the All of Us Research Program (@AllofUsResearch) at the National Institutes of Health. Dara is leading efforts to engage a million volunteers or more from diverse communities across the country in building one of the largest biomedical datasets in the world, and is seeking to reach out to populations historically underrepresented in research. Everyone in the U.S. is invited to join the All of Us cohort. Researchers are invited to participate in the project as well. As she describes it, the All of Us research program has “a simple mission and that is to accelerate health research and medical breakthroughs and in order to reach this goal we're asking one million or more people to share their health information to inform future health studies.” The inputs will be EHRs, health surveys, physical measurements, blood and urine samples, DNA samples. “And in the future, approved researchers, including community or citizen scientists, we hope will use this data to conduct many types of studies with the hopes of finding patterns in the data to better prevent, diagnose, and treat disease for individuals and in turn we're going to return and responsibly return information back to participants so that they can learn more about themselves and their families [and] enhance their own health.” ________________________________________________________ Listen live at 8:30 AM, 4:30 PM or 12:30 AM ET, Monday through Friday for the next two weeks at HealthcareNOW Radio. After that, you can listen on demand (See podcast information below.) Join the conversation on Twitter at #HarlowOnHC. ________________________________________________________ As conceptualized, the All of Us study sounds like it’s a combination of the VA’s Million Veterans genomic study and the Framingham study – gathering a variety of data types over time – everything from socioeconomic data, to lifestyle data, to environmental data, to health record data, to genomic data gathered through biobanking and sequencing, to data collected through questionnaires, with a goal of creating a dataset drawn from a diverse population base, over the course of up to ten years, supercharged by the notion of making data and data analysis tools available to community- and citizen-scientists as well as the usual suspects – in order “to have better health and healthcare for everyone … because we know that it's the actual bringing together of all of these major factors that impacts health and wellness and disease.” In addition to the diversity of data types to be collected, Dara emphasized that a key differentiator of the All of Us program is intended to be the diversity of study participants: that “We’re talking demographically, geographically, medically and especially those who are underrepresented in biomedical research.” As we know, “when you don't have data and input from a wide variety of people you can't get the full picture of health in the United States … we really need participation from people that reflect the diversity of America. And prior research studies we have not seen that and we really are expecting our program to be a game changer in that regard.” By “focus[ing] on participants as partners in our programs … we really want participants to be involved in the governance, we want them to invent systems, and provide input into the science, and have a choice in how they get their data back and information back from our program.” Dara also expressed the program’s commitment to creating a national open resource – “open … to the public, and researchers of course, with appropriate safeguards, and open source software and tools so that [we can share] medical breakthroughs.” We also discussed the challenges of interoperability and ... I recently spoke with Dara Richardson-Heron M.D., chief engagement officer of the All of Us Research Program (@AllofUsResearch) at the National Institutes of Health. Dara is leading efforts to engage a million volunteers or more from diverse ... David Harlow https://healthblawg.com/2018/12/oswal-cisco-networks.html Anand Oswal, SVP at Cisco, on Building a Better Network – Harlow On Healthcare http://feeds.healthblawg.com/~/590262346/_/healthblawg~Anand-Oswal-SVP-at-Cisco-on-Building-a-Better-Network-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/590262346/_/healthblawg~Anand-Oswal-SVP-at-Cisco-on-Building-a-Better-Network-Harlow-On-Healthcare.html#comments Mon, 24 Dec 2018 14:11:39 +0000 https://healthblawg.com/?p=5859

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]]> http://feeds.healthblawg.com/~/590262346/_/healthblawg~Anand-Oswal-SVP-at-Cisco-on-Building-a-Better-Network-Harlow-On-Healthcare.html/feed 1 Interview,Audio,Harlow on Healthcare,Healthcare Innovation,Artificial Intelligence,HIT,Health care policy,Health Law,Security,Podcast Sitting with me by my virtual hearth is Anand Oswal, Senior Vice President for Cisco's enterprise networking business. He is responsible for building the complete set of platforms and solutions for the Cisco enterprise networking portfolio across routing, access switching, IoT connectivity, wireless and network cloud services deployed at customers worldwide. We discussed the need for security as the foundation for networking in healthcare and other industries, and the development of security as a function baked into hardware, software and network applications – including the ability to detect characteristic signatures of malware even within a stream of encrypted traffic. We also talked about software-defined wide-area networking (SD-WAN) as a type of environment that can enable improved performance for individual applications, and multi-cloud environments that can reduce latency and bridge connections between systems and organizations as needed. Listen in to our conversation about reducing the burden on users and administrators while lowering cost and improving network security. I spoke with Anand as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare, on HealthcareNOW Radio. Listen to our radio station online, or ask your smart speaker (Amazon Echo or Google Home): “Find Tune In station HealthcareNOW Radio.” You can catch me live weekdays at 8:30 am, 4:30 pm and 12:30 am ET. As each new show goes live, the last one joins the archive, available via SoundCloud or your favorite podcast app (iTunes, Stitcher, iHeartRadio). Your comments are welcome here. Join the conversation on Twitter at #HarlowOnHC. David Harlow The Harlow Group LLC Health Care Law and Consulting Sitting with me by my virtual hearth is Anand Oswal, Senior Vice President for Cisco's enterprise networking business. He is responsible for building the complete set of platforms and solutions for the Cisco enterprise networking portfolio across ... David Harlow https://healthblawg.com/2018/12/neumann-cost-effectiveness.html Tufts’ Peter Neumann and cost-effectiveness analysis – Better health through better measurement – Harlow On Healthcare http://feeds.healthblawg.com/~/584722376/_/healthblawg~Tufts-Peter-Neumann-and-costeffectiveness-analysis-Better-health-through-better-measurement-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/584722376/_/healthblawg~Tufts-Peter-Neumann-and-costeffectiveness-analysis-Better-health-through-better-measurement-Harlow-On-Healthcare.html#comments Mon, 10 Dec 2018 14:05:11 +0000 https://healthblawg.com/?p=5810

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]]> http://feeds.healthblawg.com/~/584722376/_/healthblawg~Tufts-Peter-Neumann-and-costeffectiveness-analysis-Better-health-through-better-measurement-Harlow-On-Healthcare.html/feed 1 Population Health,Audio,Harlow on Healthcare,Prescription Drugs,Health care policy,Health Law,Value Based Purchasing,Podcast My guest for this edition of Harlow on Healthcare is Peter Neumann. Peter is the Director of the Center for the Evaluation of Value and Risk in Health (@TuftsCEVR) at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center (@TuftsMedicalCtr), and is a professor of medicine at the Tufts University School of Medicine. Peter’s quick definition of cost effectiveness analysis is a tool that helps us measure value, looking at costs of treatment and health effects and the cost per unit of health effect; for example, “the cost per life-year gained with a new drug is one way of measuring the value of that drug.” The goal is to make the measurements objective so that the cost-effectiveness of one treatment for one population may be compared with that of another treatment for another population – by using measures such as quality-adjusted life-years (QALYs). However, subjective value judgments often creep into the calculus: Are we willing to spend more on cancer? On children? The subjective value judgments are at the heart of policy discussions, but the objective measurements help ground the discussion. We spoke about the “Second Panel” on cost-effectiveness in medicine and health and a recent paper Peter co-authored on recommended areas for future research in the field. One area that was very interesting to me was the notion that we should be looking at health effects on caregivers of patients as part of the calculus. Peter observed that “the patient is the primary recipient, consumer and audience who receives the value but there are other important audiences as well, [like] caregivers…. [I]f you treat the patient with substance abuse disorder and that patient is managed well obviously the patient benefits but the caregiver benefits a lot. The family of that patient benefits a lot. Society benefits. And so the idea is if we really want to capture value we should be thinking more broadly about the audience not only the patient but the caregivers, the families, society; and in a kind of similar way there may be other sectors beyond healthcare that benefit that we might want to think about and in fact try to quantify.” For example, treatment of a patient with substance abuse disorder may result in a reduction in crime, in an increase in productivity. Given the differences in state-by-state approaches to the opioid epidemic (e.g criminal enforcement vs. treatment and rehabilitation) we have a natural experiment that can yield data to be looked at in a cost-effectiveness analysis. As Peter observed, it is challenging to include the non-health costs and benefits in the analysis. And it is also challenging to measure because a strict quality model would be indifferent to the sequence of events and to the weights that would be assigned to different experiences by individual patients. “People may care about the order in which events happen; they may care a lot about not just how long they're going to live but what is the probability that they'll live until their son or daughter gets married …. The quality doesn't always capture the richness of patient preferences about treatments about side effects about how a drug is administered about whether it's at home or in a clinic and on and on the quality can't possibly capture all of that complexity.” “We try to be as objective and scientific as possible and then provide input into the policymakers’ decisions, the clinical decisions, the government and business decisions…. We're trying to be technically as sound as we can. But we also have, I think, some humility about our ability to do it well. And part of what we're doing is trying to characterize the uncertainty around the decisions but also recognize that the end of the day there are doctors and patients making decisions and patients making decisions about their own health. Those are very, very difficult. ... My guest for this edition of Harlow on Healthcare is Peter Neumann. Peter is the Director of the Center for the Evaluation of Value and Risk in Health (@TuftsCEVR) at the Institute for Clinical Research and Health Policy Studies at Tufts Medical ... David Harlow https://healthblawg.com/2018/11/shor-medisafe-adherence.html Omri Shor of Medisafe presents targeted medication adherence tools – Harlow On Healthcare http://feeds.healthblawg.com/~/584068558/_/healthblawg~Omri-Shor-of-Medisafe-presents-targeted-medication-adherence-tools-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/584068558/_/healthblawg~Omri-Shor-of-Medisafe-presents-targeted-medication-adherence-tools-Harlow-On-Healthcare.html#respond Mon, 26 Nov 2018 15:17:44 +0000 https://healthblawg.com/?p=5819

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]]> http://feeds.healthblawg.com/~/584068558/_/healthblawg~Omri-Shor-of-Medisafe-presents-targeted-medication-adherence-tools-Harlow-On-Healthcare.html/feed 0 PHR,Interview,Audio,Patient safety,Digital Health,Harlow on Healthcare,Healthcare Innovation,HIT,Health care policy,Health Law,mHealth,Chronic care,Mobile health,Value Based Purchasing,Pay for performance,Podcast Joining me by my virtual hearth this week is Omri Shor (@OmriShor), CEO and co-founder of Medisafe (@MedisafeApp). Omri was inspired to create Medisafe after his father accidentally double-dosed on insulin. He describes Medisafe as a medication management platform providing personalized support. He and his team have grown the user base of Medisafe’s medication adherence application to over 4 million users worldwide. I challenged Omri, suggesting that the fundamental problem around medication adherence is not about getting better nudges out to patients but about affordability of medications and about patients not wanting to self-identify as chronically ill. Omri’s response addressed the issue pretty comprehensively, first noting that 25-30% of medication adherence issues are due to forgetfulness, so the app’s reminders can be tremendously helpful. However, Medisafe is also building behavioral science into its service, identifying the reasons for nonadherence for each patient and implementing a plan, and delivering content, that addresses each patient’s issues and motivation effectively, based on a personalized profile. We don’t “talk about illness or sickness. We’ll talk … in a much more positive way.” And in a way that is tuned to the patient’s therapeutic, demographic, socioeconomic and other characteristics. For example, reminding a diabetic patient aged 50 or above that their health matters to their family yields about a 20% increase in patient engagement (which translates to medication adherence), while the same messaging delivered to a millennial yields only a 5% increase. “So the app essentially analyzes who you are and based on those determinants will start changing both the content as well as the messaging for each and every individual. And that's really the sophistication that we've built over the years inside the platform. This is the truly secret sauce — the ability to really change and talk to different people in different voice.” Next, we discussed value-based payment models that Medisafe is employing with its customers. Starting with the understanding that “700,000 people a year are about suffering emergencies due to medication management issues, … we [Medisafe] believe that we can help those folks improve their conditions by adhering to their medications.” Adherence issues also cost pharma companies, since fewer doses are sold if doses are not taken – the lost revenue was in excess of $280 billion a year for one recent year. Medisafe has done their homework and Omri says that if we “can indeed create value for the industry why wouldn't [we] be willing to put some skin in the game?” Medisafe offers two models of partnerships. The first is a flat licensing fee (licensing the Medisafe platform to pharma companies to help improve patient adherence). The second is a value-based model, tied to patient engagement, and the company has the data and the confidence to contract with pharma companies on that basis. Omri notes that value-based contracting is the future of healthcare contracting across the board “because we can’t afford it any other way [and] a few years from now anyone who's not going to be willing to be measured on the value that they bring will not survive. Simple stuff. So we want to be ahead of the game. We do have data to show that we prove value. We are happy to share that value with our clients.” And here is the highlight of our conversation: “You know, as much as we can say that about a contract, it's actually pretty fun.” (Be still, my legal heart!) Since not everybody has as much fun with contracts, Omri notes that Medisafe’s integration with Apple Health allows participating hospitals and health systems to offer their patients the ability to add their medications to their electronic health record data without the need ... Joining me by my virtual hearth this week is Omri Shor (@OmriShor), CEO and co-founder of Medisafe (@MedisafeApp). Omri was inspired to create Medisafe after his father accidentally double-dosed on insulin. He describes Medisafe as a medication ... David Harlow https://healthblawg.com/2018/11/roi-on-ai.html Is there an ROI on AI? http://feeds.healthblawg.com/~/580407072/_/healthblawg~Is-there-an-ROI-on-AI.html http://feeds.healthblawg.com/~/580407072/_/healthblawg~Is-there-an-ROI-on-AI.html#respond Thu, 15 Nov 2018 14:50:40 +0000 https://healthblawg.com/?p=5787

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]]> http://feeds.healthblawg.com/~/580407072/_/healthblawg~Is-there-an-ROI-on-AI.html/feed 0 Big Data,FDA,Medical Devices,Healthcare Innovation,Artificial Intelligence,Machine Learning,HIT,Internet of Things,Health care policy,Health Law,Health Insurance,Managed Care A survey of C-level healthcare execs conducted by OptumIQ finds that the overwhelming majority of those surveyed believe that there will be a positive ROI on artificial intelligence investments in healthcare. Even allowing for the fact that OptumIQ sells AI solutions to those same healthcare organizations, the survey is worth mining for insight into the expectations that healthcare leaders have when it comes to AI. - Employers and health plans expect their AI investments to begin yielding a positive ROI within three years, and hospital execs expect it to take four or five years. - Employers are furthest along in deploying AI solutions in healthcare, though three-quarters of all those surveyed say they are either planning or implementing an AI strategy. - The key benefits respondents expect to see form AI are more accurate diagnosis and increased efficiency. Of those health organizations that are already investing in and implementing AI: - 43 percent are automating business processes, such as administrative operations or customer service - 36 percent are using AI to detect patterns in health care fraud, waste and abuse - 31 percent are using AI to monitor users with Internet of Things (IoT) devices, such as a wearable technology It is worth noting that much of the existing use of AI is in non-clinical areas of healthcare administration. The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted. (Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device; folks need to be aware of those lines, and of the shifting regulatory landscape.) Optum is looking at trying to predict atrial fibrillation using AI in order to permit clinicians to intervene earlier with preventive measures, thereby reducing the burden of disease (including the cost of treatment). Research indicates that 13% of atrial fibrillation is undiagnosed, so identifying patients in need of preventive services could affect a significant patient population. Since half of the 700,000 undiagnosed patients are at moderate to high risk of stroke, prevention could make a difference. Another interesting survey released this week by PwC on Digital IQ, found that their respondents broke down into modernizers, efficiency seekers, industry explorers and redefiners. The first three groups seek to use digital tools to tweak their businesses, but the fourth group, the redefiners, comprising about a quarter of the respondents, are using these tools to transform their businesses at a more fundamental level, not by simply adopting digital tools here and there. Similarly, if AI tools are going to transform healthcare organizations, they will need to be applied stem-to-stern, and not just on a piecemeal basis. AI tools in healthcare (however we may define them) are still in their early stages of development, and they will need to be applied successfully to a broader range of populations and diseases, as well as business processes, in order to prove their value and truly deliver a compelling ROI. But the early returns are promising. David Harlow The Harlow Group LLC Health Care Law and Consulting A survey of C-level healthcare execs conducted by OptumIQ finds that the overwhelming majority of those surveyed believe that there will be a positive ROI on artificial intelligence investments in healthcare. Even allowing for the fact that OptumIQ ... David Harlow https://healthblawg.com/2018/11/doctor-as-designer.html Joyce Lee, Doctor As Designer talks design thinking — Harlow On Healthcare http://feeds.healthblawg.com/~/579791106/_/healthblawg~Joyce-Lee-Doctor-As-Designer-talks-design-thinking-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/579791106/_/healthblawg~Joyce-Lee-Doctor-As-Designer-talks-design-thinking-Harlow-On-Healthcare.html#comments Mon, 12 Nov 2018 15:10:26 +0000 https://healthblawg.com/?p=5781

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]]> http://feeds.healthblawg.com/~/579791106/_/healthblawg~Joyce-Lee-Doctor-As-Designer-talks-design-thinking-Harlow-On-Healthcare.html/feed 1 Interview,Population Health,Audio,Digital Health,Harlow on Healthcare,Participatory Medicine,Healthcare Innovation,HIT,EHR,Health care policy,Health Law,Podcast Joyce Lee MD MPH brings design thinking to academic medicine, and is making a difference in the lives of patients and clinicians by bringing them together in a learning health system. Joyce is a pediatric endocrinologist on the faculty at the University of Michigan. As a clinical and health services researcher, she is very interested in the notion that human-centered design and design thinking — combined with emerging technologies such as mobile technology, data visualization, and social media — can transform the research enterprise and the delivery of clinical care. Much of her work is focused on the confluence of all of these streams in the creation of learning health systems. You can find her on line at doctorasdesigner.com and on Twitter: @joyclee. When we spoke, Joyce brought together streams of participatory medicine, design thinking and the notion of a learning health system, emphasizing that the system – and many elements of the system – must be designed, or redesigned, with a focus on the system of users of any tool or process. This means bringing patients, caregivers, clinicians, and others to the table and engaging them in design. Joyce defines design thinking as “a form of problem solving that is participatory in nature, engaging people who are going to be using the product.” She notes that the the design process works best when it is iterative and participatory. It has to be participatory because otherwise it is difficult to know whether a designer working in isolation is even asking the right question, or solving the right problem. Empathy, listening, taking time to engage are important parts of the process. At the University of Michigan, Joyce is involved in a collaborative called Health Design By Us, involving technologists, designers, clinicians and patients. As an example of what this process can yield, Joyce described how, by listening to a teenage patient with Type 1 diabetes describe the stress she experienced texting back and forth with her parents all day while at school about her blood glucose levels, the team (including the patient) determined that a good solution would be to have a set of “emoji” symbols that could communicate simply here current state, stripping away much of the stress created by fraught communications with her parents. The team created Diabetes Emoji, which worked well for the patient and are now available in the “sticker store” for iMessage. As this example demonstrates, the issue is not simply a user experience issue; it’s a deeper issue involving the emotional side of dealing with chronic disease, the burden it places on relationships with families. “The lived experience is important – not just the clinician visit.” From Joyce’s perspective, clinicians, diabetes educators, researchers – everyone in the healthcare system – should be thinking about design and should be trained in design thinking. She is currently working on redesigning the clinician experience in Epic in connection with a certain set of patient encounters in diabetes management, using principles of user-centered design in order to make the clinician workflow easier on the clinicians. After the University of Michigan transitioned to the Epic electronic health record system, it became clear to Joyce that the EHR is not optimally designed. She became an “Epic physician builder” in order to be able to better work on optimizing tools and building her own tools for the clinic, including, for example, questionnaires for patients to answer in clinic using tablets, with “structured fields we use as clinicians to do our work and to measure outcomes,” and clinician tools for various types of encounters. Joyce notes: “We’ve come a long way. Before we had EHRs we couldn’t even tell you how many patients we had” without counting the paper charts ... Joyce Lee MD MPH brings design thinking to academic medicine, and is making a difference in the lives of patients and clinicians by bringing them together in a learning health system. Joyce is a pediatric endocrinologist on the faculty at the ... David Harlow https://healthblawg.com/2018/11/cybersecurity-awareness-takeaways.html National Cybersecurity Awareness Month Takeaways http://feeds.healthblawg.com/~/577928762/_/healthblawg~National-Cybersecurity-Awareness-Month-Takeaways.html http://feeds.healthblawg.com/~/577928762/_/healthblawg~National-Cybersecurity-Awareness-Month-Takeaways.html#comments Thu, 01 Nov 2018 23:12:44 +0000 https://healthblawg.com/?p=5770

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]]> http://feeds.healthblawg.com/~/577928762/_/healthblawg~National-Cybersecurity-Awareness-Month-Takeaways.html/feed 1 Health care policy,Health Law,OCR,Privacy,Security,HIPAA At the close of National Cybersecurity Awareness Month, a number of cybersecurity tips were published by OCR (the office within HHS that enforces HIPAA). These are timely and important reminders, relevant to everyone in the regulated community of covered entities and business associates, particularly in light of OCR's recent settlement agreement with Anthem in connection with its major breach of a couple years ago (see more on my thoughts about the Anthem breach here), as well as OCR's release of a new and improved security risk assessment tool. Without further ado, here they are: - Encryption: Encryption is the conversion of electronic data into an unreadable or coded form that is unreadable without a decryption key. The proper use of encryption can prevent unauthorized users from viewing encrypted data in a usable form and may substantially reduce the risk of compromising ePHI. HIPAA covered entities and business associates are required to assess whether encryption is a reasonable and appropriate safeguard as a means of protecting ePHI at rest (i.e., ePHI that is stored such as on a computer’s hard drive or on electronic media) and ePHI that is electronically transmitted. See 45 CFR §§164.312(a)(2)(iv), 164.312(e)(2)(ii). - Social Engineering: Phishing remains one of the most common and effective social engineering tactics for stealing user credentials and other sensitive information. Malicious actors send deceptive emails to users, enticing them to disclose login credentials or click links that may install malware (malicious software). The effectiveness of phishing attacks can be greatly reduced with proper training to keep information system users aware of the threats of phishing attacks and helps users identify suspicious emails. The Security Rule requires covered entities and business associates to implement security awareness and training programs for all workforce members including management. See 45 CFR § 164.308(a)(5)(i). - Audit Logs: Network and system activity can be recorded and monitored with logs, which are a record of events and information pertaining to whatever device, system, or software they are monitoring. Audit logs are an important security tool that allows organizations to detect suspicious activities as they are occurring and can be used to reconstruct events that happened in the past. In order to be effective, the information contained in logs should be reviewed on a regular basis. The HIPAA Security Rule requires the implementation of audit controls, i.e., safeguards to record and examine activity on information systems that contain or use ePHI (see 45 CFR § 164.312(b)) and to regularly review records of information system activity, such as audit logs. See 45 CFR § 164.308(a)(1)(ii)(D). - Secure Configurations: Proper configuration of network devices and software will reduce the attack surface for bad actors and greatly improve an organization’s cybersecurity defenses. The aforementioned tools – encryption, anti-malware, and audit logs – require appropriate settings in order to function as intended. If encryption safeguards are not implemented correctly and do not use the latest versions, the encryption solution may be compromised or bypassed. Anti-malware software settings determine what files or devices are scanned and how often. Maintenance and updating of malware definitions will ensure that the software is providing maximum protection. Proper log configuration is also essential to effective network defense. If logs do not collect and retain the correct data, suspicious activity may go unnoticed. Furthermore, logs should be protected against unauthorized manipulation or deletion, which is a common tactic malicious actors use to cover their tracks. These are just a few examples of network components that require proper configuration to provide effective cybersecurity defense. The configuration of firewalls, workstations, routers, ... At the close of National Cybersecurity Awareness Month, a number of cybersecurity tips were published by OCR (the office within HHS that enforces HIPAA). These are timely and important reminders, relevant to everyone in the regulated community of ... David Harlow https://healthblawg.com/2018/10/ryan-intel-iot.html Dave Ryan, Intel GM for IoT in Healthcare and the Future of Remote Care – Harlow On Healthcare http://feeds.healthblawg.com/~/577487366/_/healthblawg~Dave-Ryan-Intel-GM-for-IoT-in-Healthcare-and-the-Future-of-Remote-Care-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/577487366/_/healthblawg~Dave-Ryan-Intel-GM-for-IoT-in-Healthcare-and-the-Future-of-Remote-Care-Harlow-On-Healthcare.html#comments Mon, 29 Oct 2018 15:36:20 +0000 https://healthblawg.com/?p=5761

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]]> http://feeds.healthblawg.com/~/577487366/_/healthblawg~Dave-Ryan-Intel-GM-for-IoT-in-Healthcare-and-the-Future-of-Remote-Care-Harlow-On-Healthcare.html/feed 2 Hospitals,Interview,Telehealth,Audio,Medical Devices,Digital Health,Harlow on Healthcare,Healthcare Innovation,Artificial Intelligence,Machine Learning,HIT,Internet of Things,Health Law,mHealth,Chronic care,Health 2.0,Mobile health,Podcast My guest for this edition is Dave Ryan, Intel GM for Health and Life Sciences at its Internet of Things Group. We spoke at the Connected Health conference in Boston, an annual get-together of innovators in digital health and healthcare transformation which has long been on my list of regular stops on the conference circuit. Kicking things off, I asked Dave to define the Internet of Things, or IoT (noting that I had recently nearly been laughed out of the kitchen at home by some Luddite family members when I brought up IoT at dinner). Dave said, “All of the things in our lives are connected and if they aren’t they will be – your refrigerator is a thing, your refrigerator, connected to your shopping list, is a thing that’s part of the internet of things.” It’s about taking things that have been around before, “making them smart and through connecting them to the internet making the product perform better for the person who’s using it.” IoT is not necessarily just about remote sensors, and in fact the IoT story is two different stories – one inside the health care facility, and one outside. Over the past ten years, every device in the hospital has gotten connected – all information on the device digitized, and put in the hands of clinicians and caregivers. At home – as care shifts to be able to be delivered where people are – “sensors are key” per Dave – healthcare in the home is about helping the individual managing someone’s case get better information about how that person is doing between office visits. The range of issues detected by sensors range from detailed clinical readings to the very simple: “are you in your apartment?” Dave noted that in some countries someone would go over to check on someone who had left their apartment when they normally don’t. Since a key broad goal is keeping people at home rather than in healthcare facilities, Dave notes that it is important to recognize the potential for IoT devices to help promote social connectedness, connectedness to the family. It is critical in terms of health and wellness. “IoT technologies that can be used in the home can bring more connectedness to the family, not just caregivers,” and that’s really a key part of the health strategy – it’s not just about taking vital signs. We explored further the question of whether IoT in healthcare simply provides a new platform for old services and ideas or whether it enables something entirely new. Dave advanced the idea that “it’s a whole new chapter, a whole new model of how to care for folks,” stepping away from a nineteenth-century model “still deployed pervasively today” where an individual sees a PCP every three months or every six months, has a six or twelve or seventeen minute appointment and then disappears. IoT allows information and communications “connectivity between the patient and the care system” when they want it, every day, all the time. Dave highlighted some research sponsored by the Michael J. Fox Research Foundation on connected measurement through IoT devices for people with Parkinson’s. This let patients and clinicians see the changes in the effects of medication over the course of a day or a week, not just based on self-reported history during a six-minute office visit. IoT doesn’t replace office visits, but “shines a light on the dark corner of the health care system” (i.e. everything that happens between visits). Obviously, we don’t want just a flood of data, we want the data turned into insights and actionalble alerts. Dave notes that there are lots of innovations in advanced analytics and artificial intelligence that can mine these remote sensor readings and “convert data into nuggets of insight and critical triggers of action,” so ... My guest for this edition is Dave Ryan, Intel GM for Health and Life Sciences at its Internet of Things Group. We spoke at the Connected Health conference in Boston, an annual get-together of innovators in digital health and healthcare ... David Harlow https://healthblawg.com/2018/10/strategic-partnerships-kansal.html Ruchin Kansal and Strategic Partnerships: To Go Far, Go Together – Harlow On Healthcare http://feeds.healthblawg.com/~/575274148/_/healthblawg~Ruchin-Kansal-and-Strategic-Partnerships-To-Go-Far-Go-Together-Harlow-On-Healthcare.html http://feeds.healthblawg.com/~/575274148/_/healthblawg~Ruchin-Kansal-and-Strategic-Partnerships-To-Go-Far-Go-Together-Harlow-On-Healthcare.html#comments Mon, 15 Oct 2018 14:10:13 +0000 https://healthblawg.com/?p=5746

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]]> http://feeds.healthblawg.com/~/575274148/_/healthblawg~Ruchin-Kansal-and-Strategic-Partnerships-To-Go-Far-Go-Together-Harlow-On-Healthcare.html/feed 1 Interview,Audio,Harlow on Healthcare,Healthcare Innovation,Health care policy,Health Law,Health 2.0,Podcast This edition’s topic is strategic partnerships, and I had the chance to speak about them with Ruchin Kansal (@kansalruchin), the Digital Business Strategy leader for Healthcare, Insurance and Life Sciences at Virtusa. He has also worked in healthcare strategy consulting at Big Four consulting firms and as executive in charge of business innovation at Boehringer Ingelheim. He has written about innovation in healthcare and life sciences, and we have passed each other in the physical or virtual hallways of Stanford University’s Medicine X – where he’s served on the board and I’ve been a speaker. There’s a meme that says “If you want to go quickly, go alone. If you want to go far, go together.” To me, that sums up a key tension in the healthcare landscape today, between the drive for rapid innovation and the value of strategic partnerships. Before getting into that duality, though, I asked Ruchin to talk about strategic partnerships. It’s a crucial time in healthcare, and the fragmentation that is a hallmark of the US healthcare system has brought many participants to a point of frustration, and has created an opportunity for new entrants like the tech giants (Amazon, Apple, Google etc.) who are offering an alternative. Better care, lower costs – it starts to sound like the future of healthcare is going to be the future of retail: healthcare incumbents now need to compete with new healthcare market entrants, and strategic partnerships become more important to create robust alternatives for the future of healthcare. While in my opinion the crisis has been brewing for years, Ruchin’s sense it that we have only recently reached a breaking point, for the following reason: For the broad middle in the US economy — 60% of the population, with annual incomes between $40,000 and $100,000 – income is flat and healthcare costs are increasing; we need to address that because the burden of cost is now high enough that people will demand change, a consumer-driven revolution. In the past, Ruchin was involved in some pharma-linked strategic partnerships, and he had a few takeaways from that experience. Since the pharma company was a couple of steps removed from the patient, he saw that the biggest challenge was gaining an understanding of how care is paid for and experienced by patients. That required leveraging partnerships with payors and others in a patient-centric mode and led to these learnings: - There has to be a clear strategy that you can use to rally the troops, to bring resources of the organization to bear – “not just about stock price or something like that.” - There has to be leadership commitment, openness to failures along the way, commitment for a sustained period of time, or else the partnership can’t succeed. - You have to be careful to set up a workable governance structure; partnerships that were successful had equal investments of resources on both sides. - You can’t know everything when you go in – you need to be open to learn. In Ruchin’s view, Amazon/ Berkshire Hathaway/ JP Morgan Chase and others must be guided by these principles. He has a guiding principle that is eminently practical. Ruchin calls it “The 80-80 rule.” In his view, the key to success in driving innovation, whether through strategic partnerships or otherwise, is being 80% confident that you will only be 80% right the first time. As he notes, given that the cost of failure is so high, there is a desire to be 100% sure before starting a project, signing a contract, dedicate new resources — but you need to take risk, take chances; it’s OK to be 80% confident, OK if you’re only 80% right. After all, if you’re 100% confident, you’re probably wrong. To move forward, it is important to take calculated risks. When I asked Ruchin what he hopes or expects would ... This edition’s topic is strategic partnerships, and I had the chance to speak about them with Ruchin Kansal (@kansalruchin), the Digital Business Strategy leader for Healthcare, Insurance and Life Sciences at Virtusa. David Harlow