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July 16, 2014

Consumer Generated Data: Your "Data Exhaust"

YourDataItsOutThere_InfographicYou might be surprised to learn how wide your digital footprint is these days.

It is worth getting up to speed on this issue by reading Jane Sarasohn-Kahn's latest report for the California Healthcare Foundation, entitled Here's Looking at You: How Personal Information Is Being Tracked and Used. I enjoyed speaking with Jane about these issues as she was researching and writing the report.

Some highlights:

1.    Most people are unaware that they are leaving their personal data behind and that some of this information is not protected by HIPAA. Data brokers are able to build dossiers on individuals to sell to marketers, while consumers lack recourse to obtain or correct their information.

2.    Clinical researchers, health plans, and others use the information to enhance individuals' health as well as to benefit public health. Larger and speedier clinical trials are made possible by the quantity of data available.

3.    Different types of information — such as historical claims data and consumer-generated data — can be combined and used for statistical modeling for health or financial risk-profiling. Such information is purchased by hedge funds, hospitals, large provider networks, payers, pharmaceutical companies, and others.

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July 15, 2014

Health Care Online Marketing, Social Media and HIPAA - Google Hangout on Air

I recently spoke with Jon Schumacher and Michael Bloom on Health Jams -- a Google HOA series on marketing for health care entrepreneurs. This installment is a primer on health care social media, online marketing and use of online tools (including telehealth) by folks in the healthcare space and just over the line in other domains as well.

Please feel free to connect here or elsewhere on line to continue the conversation.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 09, 2014

Health Care Social Media Review #57 - The Ketchup Edition

CRI_229952Welcome to Health Care Social Media Review #57.

Warhol's Heinz 57 works insisted upon being included as part of the visual theme for the current edition. And of course a more up-to-date artistic appropriation of the meaning of ketchup may be found in the work of Garrison Keillor, on A Prairie Home Companion -- one of the show's "sponsors" is the Ketchup Advisory Board, which touts the benefits of ketchup's "natural mellowing agents." Both Warhol and Keillor latched on to ketchup to make very different points -- Warhol, to highlight the commodification of our existence by rendering the mundane with the care ordinarily reserved for the transcendent; Keillor, to give us an odd but warm feeling inside.

What do these opposing treatments of ketchup have to teach us about health care social media? Gather round as we explore recent #hcsm posts from the blogosphere and see if you can't answer that yourself by the time you finish reading this post.

Continue reading "Health Care Social Media Review #57 - The Ketchup Edition " »

June 17, 2014

#FDAsm - FDA Releases Draft Social Media Guidance Five Years After Public Hearing

FDAFive years after its most recent public hearing on the subject of social media marketing of drugs and medical devices, the FDA released a draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.

Update 7/24/2014, 11/25/2014: See my further discussion of these guidance documents in a Google+ FDA Guidance Hangout on Air and in an article on US FDA Social Media Guidance published in the UK PMlive directory of digital agencies.

Publication was prompted by a statutory deadline in the FDASIA, and there is a 90-day comment period now open. It's a little disappointing that it literally took an act of Congress to get the agency to focus and act on this issue, and that despite the focus all we're getting here is nonbinding sub-regulatory guidance.

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FDA continues to detail types of mHealth apps it will not regulate

FDASince issuing its mobile medical applications guidance, the FDA has offered a number of clarifying statements, intended to give the regulated community a clearer idea of whether and when to expect any particular mHealth application to be considered a device.

Last week, the FDA added a category of applications with respect to which it intends to "exercise enforcement discretion" (i.e., not regulate):

  • Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].

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June 06, 2014

Telehealth: Roy Schoenberg, CEO of American Well, Speaks with David Harlow

5669123427_4ab5769ecf_oI had the opportunity to speak with Roy Schoenberg about the model policy recently adopted by the Federation of State Medical Boards (FSMB): Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine. The model policy is offered as a means for state medical boards to get up to speed quickly and to access standards of care that are both protective of patients' interests and, frankly, are baselines against which physician behavior may be judged by an individual board. Roy distinguishes between telemedicine (doc-to-doc communication) and telehealth (patient-to-doc communication). The latter, particularly using a secure live video platform is a disruptive innovation in a way that the former is not: it allows patients to access medical advice at their convenience, without the need for an office visit or a trip to a specialist.

Continue reading "Telehealth: Roy Schoenberg, CEO of American Well, Speaks with David Harlow" »

May 23, 2014

The Affordable Care Act: How Provider Organizations Can Succeed Under Health Reform

The Affordable Care Act has triggered many changes in the health care delivery system. Learn about the health reform-inspired approaches to redesigning care that work (or don't work) for management of chronic conditions, including diabetes -- from ACOs to bundled payments to patient centered medical homes.

I recently had the opportunity to present to the domestic affiliates of Joslin Diabetes Center on this topic.

Continue reading "The Affordable Care Act: How Provider Organizations Can Succeed Under Health Reform" »

May 15, 2014

HIPAA for Web and Mobile Developers and Designers (and for everyone, The Data Map)

DatamapI spoke at the HxRefactored conference in Brooklyn this week. The title of my talk was Dancing with HIPAA and it was intended as an introduction to health care data privacy and security regulations, practical concerns and -- most important -- practical solutions to privacy and security issues whether subject to HIPAA or not. Many issues for this audience will be triggered by data not gleaned from a health record maintained by a health care provider or payor. Instead, such data may be released by an individual (and therefore no longer covered by HIPAA) and mashed up with data feeds from personal trackers and manually inputted data, put through a health behavior modification recommendation engine, and -- voila! -- behavior change recommendations are delivered to an individual. In this context, the health data is being held in a special-purpose PHR, not an EHR, so HIPAA rules don't apply and therefore OCR enforcement should not be of concern -- though the FTC breach notification rules apply and, as we know, the FTC asserts broad parallel jurisdiction to enforce HIPAA as well.

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May 13, 2014

Health Tech Innovation Meetup in NYC

#H2NYC Meetup - May 12, 2014. Thirteen demos and a whole lot of conversation with the health tech innovation community in NYC Monday evening. I enjoyed dropping in on the H2NYC meetup preceding the HxRefactored conference. Tweets from the event after the jump.

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May 08, 2014

Medical Groups Need to Focus on HIPAA Compliance

HIPAA-download-button-2Why is it time for a HIPAA reality check? Because (1) Data breaches are a constant threat; (2) OCR audits reveal many health care providers are not in compliance; (3) Workforce members pose a significant risk for HIPAA liability; (4) Patients are aware of their right to file a complaint; (5) OCR is increasing its focus on HIPAA enforcement; and (6) HIPAA compliance is not an option, it’s the law. Read this white paper to learn the facts and understand if you are doing enough to mitigate the risk of a breach or HIPAA violation.

I've written before about the urgency involved in ensuring physician practice HIPAA compliance. The stakes are high, and the time to address the issue is now. Read more about the landscape in this free physician practice HIPAA compliance white paper and -- if you haven't done so already -- start planning for your own group's HIPAA compliance efforts. We have some HIPAA compliance tools that you can use on a DIY basis, or we can help you with a cost-effective customized solution.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting