Summary of Digital Accessibility in Healthcare

Last week  HealthTech Build examined digital accessibility in healthcare.  The event was generously hosted by ASICS Digital.

To start the event, Geoff Freed from Perkins Access presented about digital accessibility for healthcare apps and services. Perkins Access, the consulting division of Perkins School for the Blind, provides professional services to organizations around the world who wish to make their digital products and services more accessible.

For those addressing digital accessibility, it’s important to keep in mind not just people with vision impairments, but also people with mobility, cognitive, and hearing disorders.  In fact, accessibility for mobility and cognitive conditions covers a  much larger proportion of the population.  Sometimes disabilities can be temporary such as a broken arm, a new parent with baby in an arm, or cataract surgery. Similarly the population of blindness includes many gradations of visual impairment.  Only a very small percentage are completely blind.  For example, many people have enough vision that they would not use screen readers except to get validation that they are seeing the screen correctly.

An inclusive design process involves people with disabilities from the earliest stage of napkin drawings and wireframes.  

‘You can use an eraser on the drafting table or a sledge hammer on the construction site.’ – Frank Lloyd Wright via Geoff Freed of Perkins Accessibility.

Inclusive Design may incorporate different types of people who can lend perspectives to the design, build, and test phases of a project.  For example, one user could be blind from birth and an expert at using assistive technology such as screen readers.  The system for this person should have content ordered logically for easy machine reading.  Another user might be an older person with macular degeneration who is frustrated by small text and buttons.  The system for this person should have a clear visual layout with large targets for clicking and resizable text.

An important tip is that most visually impaired people are easily overwhelmed by screens with motion.  This problem with motion on the screen also impacts many people with normal vision.  It’s worth considering whether the recent trend of integrating video into web page backgrounds is causing more harm than benefit.

Data entry forms are a common obstacle with people with disabilities.  For example, many offices are using tablets in the waiting room for patients to fill out an intake form.  Even the tablet is an accessible device, it may not be configured for the way each person is accustomed.  The system will be more accessible if the patient can fill out the form from their own device.

Another aspect to accessibility is standards, primarily the Web Content Accessibility Guidelines (WCAG 2.1) which were established in 1999 and last updated in 2018.  These are guidelines that carry no legal weight directly, but they inform law and policy.  Many laws are measured by compliance with these guidelines.

Some key things to keep in mind for mobile design:
* Orientation
* Pointer geastures
* Text space
* Color and contrast – also applies to normal vision in cases of screen glare
* Images – need text to describe the image, especially important for buttons
* Forms – use visible labels since placeholder text disappears when you start typing

Barbara Vanaki spoke about her experience as an iOS developer interested in braille, machine learning, and other aspects of accessibility.

Sixty-one million Americans live with a disability of which eleven percent are visual or audio (more than the state population of MA).  That’s a lot of people to miss when you’re building an app or service.

Surveys indicate that more than 70% of patients are interested in telehealth yet many telehealth websites are not ADA or WCAG compliant.

A good model for many aspects of accessibility can be found in the video game industry.  In MarioKart, characters say their own name  and use distinctive sounds and haptics.  Fortnite allows for the customizability of screen displays for different types of color blindness.

Along with the iPhone, Microsoft has also been a leader in accessibility.  Powerpoint can display voice captions.  XBox created a control for peope with motor impairments that can be customized with hand control or foot pedal and move controls from left to right side.  The packaging is elegant and can be opened more easily by someone with a motor impairment.

Anyone who has spent time in the hospital has experienced the volume of sound from alerts and alarms.  It’s often hard to tell what those sounds indicate.  Some of the larger machines make sounds that are scary.  There are experts who specialize in making medical machines less scary and disruptive.  An interesting experiment in this area is Care Tunes (link to Youtube:

Another use case is wheelchairs with remote controls.  A person might not have the dexterity for a standard control but could use a control that’s customizable.

This HealthTech Build event was hosted by ASICS Digital.

Summary of Telehealth Event

The HealthTech Build event on telehealth was hosted in the beautiful new Well-B innovation space in the Prudential Mall in Back Bay, part of Blue Cross Blue Shield of Massachusetts.  As part of the event, Well-B offered extended viewing hours for their very relevant exhibit on the Connected Home.

In the midst of a circle of soft chairs and pillows (Well-B has really made this comfortable), we gathered a panel of experts who are working on the frontlines of telehealth technology.


Joris Van Dam, Head of Digital Therapeutics, Novartis

David Mou, MD, MBA, Co-founder & Chief Medical Officer, Valera Health

Kelly Kernan, Director, Market Insights, AmericanWell

Mary Rollman, Principal, KPMG (Moderator)

The discussion focused on how telehealth is still in its early days but is approaching an inflection point of adoption by patients and physicians.

The hope is that telehealth can solve some of the fundamental problems in healthcare delivery.  One can imagine that at some point in the near future, telehealth will become a pervasive part of care. It will be delivered as part of a new model of comprehensive team-based care with non-clinical coaches who maintain frequent contact with patients through multiple channels including video, text chat, voice calls, and in-person visits whenever necessary.  There is every reason to think that the costs will be dramatically lower while providing a higher standard of care.

The barriers to adoption include the lack of financial incentives for physicians, conservative mindset of clinical staff and hospital administrators, state patchwork of regulatory restrictions and physician medical licensing, and slow movement toward value-based care and team-based care models with health coaches.

Here are some of our takeaways from the event.

  • Clinical research
    • Telehealth has great potential to bring down the cost of clinical trials and make the research more effective. Less labor would be required for remote patients.  It allows the use of a large representative population instead of a smaller skewed population based on whoever can visit one of the clinical trial sites. 
  • Adoption
    • Demand from customers is driving new specialized areas of service like acute care and behavioral health.
    • There is often patient bias against telehealth based on the perception that it’s a second rate product when compared to a clinic visits.  Valera has found that offering both in-person visits and telehealth increases the perceived value of telehealth as value-added. Even if the patient doesn’t want an in-person visit, they want to have the option.
    • AmericanWell has experience from the early days of telehealth.  On the hospital side, many earlier customers were large healthcare systems who had experimental budgets to invest in specific clinical scenarios like telestroke while today’s customers want enterprise platforms that involve an internal IT department and make the service broadly available across many clinical practices.  On the health plan side, earlier customers were checking a box for employer clients to offer a perk to employees, while today’s companies are more strategically exploring segments like managed medicare and small employer plans.
    • A less positive data point is that one of the largest insurance companies reportedly has  less than 1% adoption of telehealth. This shows it’s still early days, even if changing fast.
    • Valera has seen that behavioral health physician adoption is often especially slow.  Physicians are generally comfortable with the current system and don’t want to make a change to their workflow. A physician may show interest in telehealth and try it for a day but will never make the shift to full-time. Of course, any impact on salary is a major factor in these decisions.
    • Fewer older people want telehealth, but not a dramatically lower number than millenials. The older population might want different telehealth use cases such as writing prescriptions.  Old people are much more loyal to a PCP (8% would leave their pcp) than millenials (40% would leave).
    • Younger physicians are more likely to adopt telehealth as is true of other new technologies.  A parallel is the example of Iora health where founder Rushika Fernandopulle went to the Brigham and asked for physicians who wanted to try something new.  He got a lot of interest from good physicians who were focused on the mission instead of the paycheck. The same trend can also be seen in the C suite of health plans and hospitals. There is currently a change of guard to people in their 40s and 50s who are more receptive compared to the previous generation.
    • Some telehealth platforms are software only while others are full solutions that include staffing of telehealth physicians and other clinical care providers.
  • Telehealth and collaborative care
    • One reason that health coaches make sense is they allow physicians to keep focused on more complex care.  New models for reimbursement are beginning to make this possible, including a CMS experiment that makes payments for physicians who refer patients.  
    • There is interest in task shifting by physicians so that only complicated cases rise to the top physician level.  For many chronic conditions, the provider will view mental health as a distraction from the primary disease measures they are working toward.  The physician is often happy to quickly hand off mental health care to someone else. At the same time, the patient can reach their objectives which often prioritize mental health over physical measurements like functional ability that are perceived by physicians to be a greater priority.
    • Collaborative care is proven by RCTs to provide better care and save money.  The patient connection is the most important thing and care should be optimized for human relationships.
    • The old model for psychiatry is 45 minute sessions because that is what the billing codes reimburse.  But testing has found that more frequent short interactions like texting are more effective, reduces stigma of visiting the office.
  • Rural Care
    • A rural success example comes from Hawaii and was focused on behavioral health.  Telehealth can be good for isolated populations because it reduces stigma when everyone personally knows the local mental health provider.
    • Rural healthcare uptake has been less than predicted, perhaps due to rural patient expectations of traditional in-person doctor visits.  In addition, the rate of rural adoption might be counterbalanced by the urban population’s greater desire for on-demand convenience and high rates of technology adoption.
  • Liability
    • There is a lot of discussion about the line for health coaches to prevent them from providing medical advice. Ultimately it’s important to have rigid protocols for escalation. The risk involved may be analogous to the case of Tesla automatic driving where the company has been punished for fatalities even though their systems have been shown safer than human drivers.  It’s common that new technologies are penalized more.
    • The liability for behavioral telehealth can be strange.  Some doctors will say they would rather not want to know if a patient is suicidal for liability reasons.  Valera’s founder is doing research at Harvard that uses movement data to estimate risks of suicide. Protocols can be more comfortable for physicians.
  • Advice for founders
    • You are never selling to one customer and you need to understand the incentives of everyone.  It’s important to demonstrate enough value to change current behaviors. It’s not helpful if the non-clinical people say your system is amazing while doctors say they won’t use it.  Today most startups are showing up with some clinical research so a financial business case may be important.
    • Don’t assume that people always care about their health, sometimes behaviors are different to what you might think.
    • Engagement can be more important than exciting innovations like AI and machine learning.  An example is Livongo who have become a very successful company with only basic enabling technology that allows people to form a social bond.  Focus more on clinical process than new tech.
  • Medicaid and severe mental illness
    • In the medicaid population, patient compliance is difficult.  For insurance companies, it often makes sense to buy the patient a smartphone and teach them how to connect with Wifi. Communications response time by providers can be important for compliance by this patient population.  If there is latency of over 2 days, the compliance decreases. On the other hand, patients with severe mental illnesses like schizophrenia are one of the most high compliance populations. This may be because they don’t want face to face interactions.
  • Regulatory and reimbursement
    • Regulatory barriers are real.  Just last year, Texas became the last state who’s state board of health made telehealth permissible.  This is partly a legacy of physicians being defensive out of a fear that telehealth might steal patients.  Today the challenge is reimbursement. In 40 states aand DC there are parity laws for reimbursement so that health plans must cover telehealth.  However this rarely includes equal reimbursement. In 30 states, there are laws for Medicaid.
    • Within this landscape, it’s not surprising that physician adoption is low. This is slowly changing as CMS are adding a few codes for remote patient management and patient visit by telehealth.
    • One challenge is that many physicians are often not good billers and may miss opportunities to bill for services such as addiction counseling.
    • One of 8 ED visits is psychiatry but there are rarely enough physicians and the cost of a behavioral health telehealth visit is far cheaper than an ED visit.
    • Telehealth will become a tool for value based care, but value based care is not happening as fast as hoped.
  • Other thoughts
    • In 10-15% of cases, they recommend a personal meeting instead of telehealth.  For example, this is advisable for the first visit of a bipolar person. But if the person can’t get care or doesn’t have insurance, Valera will provide care without payment in the interim.
    • Depression in MS is different than depression in cancer. Some psychiatrists will be better with different types of patients.
    • One interesting trend is the consumerism of healthcare.  Companies are trying to make telehealth as a digital front door so that patients can easily access services and interact.  This is culturally very challenging for hospital systems and providers who do not historically align themselves around the patient as customer.  Healthcare now has to catch up with what’s been standard in other industries.

Speaker biographies:

Joris Van Dam, Head of Digital Therapeutics, Novartis

Joris is a Digital Health intrapreneur with 15 years’ experience in Pharmaceutical Research & Development, focusing on the use of digital technologies to transform therapeutic innovation, patient engagement, and clinical trials operations. Joris currently leads the Digital Therapeutics initiative at Novartis Institutes for BioMedical Research, including its collaboration with Pear Therapeutics. Prior to that, Joris launched a number of digital health initiatives involving EHR integration, pharmacies, and mobile health applications in Africa and India. Joris holds a PhD in Artificial Intelligence from the University of Amsterdam.

Kelly Kernan, Director, Market Insights, AmericanWell

Kelly started her career in healthcare in policy, at the Medicare Payment Advisory Commission. From there, she went to California to help run the largest private pay for performance program in the country, at the Integrated Healthcare Association. Kelly has been at American Well for two and a half years, where she leads the Market Insights team – keeping the company up to date on the telehealth landscape and key trends affecting American Well customers. She has an MBA and an MPH from Dartmouth.

David Mou, MD, MBA, Co-founder & Chief Medical Officer, Valera Health

David is the co-founder and Chief Medical Officer of Valera Health, a venture-backed digital healthcare company that empowers healthcare organizations to manage chronic medical and mental health. David is a psychiatrist at Massachusetts General Hospital (MGH) where he conducts research on prediction of suicidal thoughts and behaviors and a Soros Fellow, a Horatio Alger National Scholar, and a Blavatnik Fellow at Harvard Business School. He graduated from Harvard College with an honors degree in neurobiology, and earned his MD MBA from Harvard Medical School and Harvard Business School. His writings have appeared in the New England Journal of Medicine.

Mary Rollman, Principal, KPMG (Moderator)

With more than twenty years of experience as both a practitioner and consultant Mary has experienced all aspects of today’s global business. Working across industries including: pharma, biotech, medical devices, consumer goods, consumer electronics, federal government, high tech, oil and gas, she brings a unique perspective to her clients. She has run day to day operations, led large transformation programs, designed and led leadership programs to grow talent and managed M&A due diligence efforts and post merger integrations. 

A big thanks goes to Well-B for hosting the event.  Also our appreciation goes to Rightpoint for sponsoring the event’s generous spread of food and drink.

Summary of Clinical Trials Technology Event on November 5th, 2019

We had a great event last week on clinical trials.  A big thanks to our speakers:  Carrie Northcott of Pfizer, Melissa Naylor of Takeda, and Wendy R. Sanhai of Deloitte.  Also thanks to our host RightPoint Boston and our event partner the Healthcare Businesswomen’s Association.

Event with Carrie Northcott, Melissa Naylor, and Wendy Sanhai at RightPoint Boston.

Here are ten takeaways from the discussion:

  • Digital endpoints have many advantage over traditional clinical endpoints in clinical trials. Data can be collected 24/7and can be randomized by time. Measures can be continuous which is more effective at assessing quality of life. Digital endpoints can take away the burden on the patient to make repeated clinic visits which also reduces the trial cost. Digital endpoints can also help make sure that trial participants aren’t downplaying their reported symptoms or practicing for tests in advance of clinic visits.
  • Digital endpoints include data collected from a growing variety of devices. Some of the devices discussed include thermal radiography sensors and accelerometers for itching and scratching, mobile apps for measuring cognitive ability, wearables to measure the motions of Parkinson’s, image recognition of facial expressivity, tracking social phone interactions in schizophrenia, and detection of pill taking.
  • New digital endpoints need to be validated in comparison to traditional clinical measures. One challenge is that the original clinical measures may not be very useful or accurate in comparison to the new digital measures. Another challenge is that the digital data sets are often huge (4 terabytes of data per study is typical). So the initial phase of a trial exists only to validate the new technology with the targeted population and a control group and won’t include drugs or other treatment.
  • Digital measures can be especially valuable for conditions that involve difficult to measure cognitive changes like Alzheimers and Parkinson’s. The collection of large sets of data from multiple sensors and devices that interact with patients give hope for the discovery of more effective ways to measure early stages of the disease.
  • When choosing a device for data collection, it’s important to keep in mind that most people don’t live in Boston or Silicon Valley. People may be uncomfortable using technology, may have no wireless connectivity at home, and can’t be relied upon to keep batteries charged. It’s often the best practice to choose a devices with no screen and no connectivity that can be dropped at the clinic at the end of the trial period to extract the data.
  • There’s an important trend in clinical trials to become more patient centered. This is increasingly leading to sharing a participant’s data with them at the conclusion of a trial. Sharing data too soon isn’t recommended because it can lead people to change their behavior and skew the trial results.
  • Security is a growing area of concern. Many technology companies are new to healthcare and don’t have experience with the rigor of a regulated environment. One example includes a technology company in the midst of a clinical trial that was infiltrated by hackers who threatened the company with ransom. Since the company had no cybersecurity policy, they lacked the means to notify trial participants of the threat to their health.
  • Another rising issue is data privacy and ownership. As the big tech companies of the world become involved in healthcare and come into contact with the FDA, there will need to be changes to the way they have previously handled privacy. One way the FDA is addressing this is through their Center of Excellence for Digital pre-certification program which consists of a background check on companies to demonstrate they have a good track record.
  • Biotech companies working with technology vendors have a different set of challenges. Many vendors will try to keep their algorithms proprietary as a black box which makes validating the data more difficult. In other cases, vendors will want to publish early training data that shows initial signs of success, which is misleading if the data hasn’t yet been validated. Another area of concern are the statistical impacts of software that is modified during the course of a study or trial, for example an algorithm or the underlying software OS.
  • We are at a point in time when the rising costs of clinical trials are at a pace to become unsustainable. Digital endpoints offer an opportunity to bring down the cost of trials while increasing their effectiveness.

Hosted in partnership with the HBA

Summary of the Digital Chronic Care event (2019)

Event hosted by HealthTech Build on October 1st, 2019

  • Michael Sturmer, SVP Health Services Segment, Livongo
  • Maria-Louisa Izamis, Innovation Program Director, Philips
  • Piali De PhD, Founder & CEO, Senscio Systems
  • Patricia Bloom MD, Clinician Investigator, Massachusetts General Hospital
  • Jonah Comstock (Moderator), Director of Content & Editor in Chief, HIMSS Media

A little nudge can dramatically change a person’s health for the better.  Many people with diabetes only check their blood sugar levels once a day. This may miss moments of dangerously low levels at other times.  A simple nudge to adjust the time of their glucose check, as described by Michael Sturmer of Livongo, can improve health outcomes through a technology platform that incorporates a human touch.

A panel of digital chronic care experts discussed the challenges of providing high quality care for people with chronic conditions at a HealthTech Build event moderated by Jonah Comstock of HIMSS.

The obstacles for chronic care can perhaps best be understood through the concepts of episodic care and continuous care, as described by Piali De of Senscio Systems.  In episodic care, people get sick and visit a hospital or clinic, get diagnosed, and are given a plan for treatment. After the visit, there is typically little engagement with clinical staff and further treatment becomes the responsibility of the patient.

By contrast, continuous care involves the patient at home, at work, or in the hospital.  To do continuous care properly, there needs to be a way of monitoring the patient remotely and engaging with them frequently.

In the United States today, the healthcare system is built around the model of episodic care.  Most physicians lack the resources to follow up with their patients which may number in the thousands.  And financial incentives are mostly aligned around a fee-for-service model of visits and procedures which discourages an ongoing relationship with the patient.

Episodic care is particularly a problem for people with multiple chronic conditions who have complex needs that require additional engagement from clinical providers, as explained by Patricia Bloom MD of Mass General.  People with liver disease are often dealing with drug and alcohol addiction and socioeconomic factors. They may arrive at the hospital with a serious condition that is treated before being discharged back into an unsupportive environment.

The consensus of the panel was that an effective solution should incorporate both technology and a human care network.  

The technology components include remote monitoring through connected glucose monitors or blood pressure cuffs, algorithms and artificial intelligence that automatically identify and alert about patient problems, and interfaces for engagement between the patient and clinical care team.  The human element includes a central point of contact that may be a health coach or social worker in combination with a clinical team of nurses and physicians and other specialists.

The good news is that digital chronic care is moving forward quickly.  Newly public companies like Livongo are reaching hundreds of thousands of patients, new companies like Senscio are bringing together the newest technologies for patient care, hospitals like Mass General are adopting digital systems to better care for chronic conditions, and multinational companies like Philips are integrating a diverse set of monitoring products to work across institutions.

Piali De of Senscio described founding a company to serve aging parents with multiple chronic conditions.  The goal of Senscio is to gently guide people toward better care without taking away autonomy. The Senscio platform collects large amounts of data in the home and uses artificial intelligence to identify patient problems and escalate if necessary to a human care network.

Dr Patricia Bloom explained her experience as a physician for patients with chronic liver conditions.  Hospitalized patients would spend weeks to get on the perfect regimen and receive education, but after discharge there would be little or no contact unless the patient reappeared at the hospital.  To address this, her team has implemented the PGHD Connect remote monitoring system from Partners HealthCare to remotely track the health of liver patients. A member of her team regularly observes the patient monitoring results and can make a phone call to the patient if there is a problem.

Michael Sturmer of Livongo spoke about how the Livongo model is centered around the patient to deliver better outcomes while lowering costs.  As someone who previously spent years on the payer side of the industry, he detailed the challenges of breaking into the market from a financial perspective.  Some of Livongo’s earliest customers were large employers who had the funding to add to their employee benefits. During this time, Livongo was able to calculate a return on investment based upon  lower utilization of outpatient services in the short term and improvements to patient health that led to utilization of lower severity services in the long term.

Maria-Louisa Izamis described how Philips has many products for digital chronic care including devices for us in clinical settings and at home.  The large reach and scale of Philips has allowed them to standardize across hospitals and encourage sharing of algorithms between sites with the goal that patients can walk into different institution and receive similar benefits to their care.

While can anticipate that the healthcare system will move slowly, there are positive signs that things are headed in the right direction. Livongo’s success metrics are a model for the industry, Medicare has opened new paths for reimbursement for ongoing services like remote monitoring, and employers and payers are increasingly experimenting with patient-focused models.

And we can expect technology to continue at a rapid pace to deliver smaller and cheaper home monitoring devices, improved sensors, more sophisticated algorithms to pinpoint patient problems and guide clinical decisions, and new voice and video interfaces for communications between patients and providers.

Summer Liquidity Networking Event

Join us to raise a glass for this summer’s recent healthtech IPO successes. 2019 has been a milestone year for the healthtech sector, and we look forward to this trend continuing.

The companies going public this summer include:

Livongo – Technology for personalized tracking and actionable feedback for people with chronic conditions. LVGO (NASDAQ).

Phreesia – Automation of patient intake process. PHR (NYSE).

Healthcare Analytics – Data analytics technology for healthcare providers. HCAT (NASDAQ).

We hope this infusion of funds into the sector will accelerate the path to improved patient outcomes and effective care.

When: Tuesday, August 13th at 6pm

Where: Ned Devine’s in Faneuil Hall (inside on 2nd floor)

This summer party is a joint effort by several Boston collaborators in HealthTech, including…

New digital health research site Exits and Outcomes

The Boston team (formerly RaizLabs) of Rightpoint Healthcare and Medicine

The Boston life sciences team of investment bank Outcome Capital

Apple Research Kit – Boston with Behavioral Health Innovators

Understanding the Digital Revolution in Medical Devices (4/10/19 Event)

By Matt Gross

If a ride-sharing app can detect when a passenger is having a heart attack, should that app be allowed to notify clinical staff?  That scenario was among the challenging digital health topics tackled at a recent HTB Boston event by experts from Boston Scientific, Medtronic, Analytics 4 Life, and Outcome Capital.

While digital technologies are starting to make a significant impact in many sectors of healthcare, market data indicates that we’re still in the earliest days with a steep growth curve ahead (source: Outcome Capital).

That growth will occur across a variety of healthcare sectors.

From the viewpoint of David Feygin of Boston Scientific, digitization will come first to areas with significant data flows or where there are frictions that need to be addressed.  Examples include the digitized capture of medical imaging with AI, telehealth, clinical trials, and population health.

For Geoff Dacosta of Medtronic, the surgical division is his area of focus for digital change.  Many companies are starting to digitize surgery from robotics to machine learning. One of the fundamental challenges is distilling actual surgery into bytes and voxels and compressing actions into a format that’s accessible to machines for the development of surgical algorithms.  Once digitized, surgery data can be supplemented by biologic and genetic data. Another area of surgical practice with great potential to benefit from digital technologies is post-operative recovery. New post-operative algorithms for regimen and prescriptions can be personalized to target treatment to an individual patient’s specific surgery.

Continue reading “Understanding the Digital Revolution in Medical Devices (4/10/19 Event)”

April 2019 – Understanding the Digital Revolution in Medical Devices

HealthTech Build is hosting a unique discussion about changes in the MedTech landscape with leaders from Boston Scientific, Medtronic, and more. Join us for this free event!

When: Wednesday, April 10th, 6:000 – 8:00PM
Where: WPI Seaport, 303 Congress Street, Boston

Eventbrite - Understanding the Digital Revolution in Medical Devices

Join representatives from leading MedTech companies to understand the role technology is playing in the next generation of medical devices. The discussion will cover emerging trends in business and science as medical devices and digital technology converge.

This event is intended for entrepreneurs and leaders from MedTech businesses who want to navigate the business and regulatory complexities of the MedTech space. This event will also be of interest to developers, medical researchers, clinicians, data scientists, and more.

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Recap of 2/5/19 Event: Innovation at the FDA and the MyStudies App

By Matt Gross

Nobody knows better than the FDA that gathering real world evidence is challenging.  A new initiative called FDA MyStudies offloads the burden of technology infrastructure while making participant engagement as easy as checking an Instagram feed or ordering an Uber.

Last week at HealthTech Build in the Boston Seaport an interactive audience learned how this new open source software initiative is now freely available for implementation by any research team.

To understand FDA MyStudies, it’s perhaps easier to walk through a scenario.  Imagine a team of researchers who are investigating the association between levels of physical activity and prediabetes.  They want to study a population of 1000 people at risk and measure their activity over the course of several months.

Once their study plan is approved, the research team decides to send an invitation to a list of patients from their institution who have expressed interest in research.  These patients receive an invitation on their phone by text message containing an enrollment token and a link to download the app which has been branded with the institution’s colors and logo.  

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FEBRUARY 2019 – Innovation at the FDA: Introduction to MyStudies, An Open Source App and Platform for Patient Research

Join us for our kickoff event for 2019!

When: February 5th, 5:30 – 7:30PM
Where: WPI Seaport, 303 Congress Street, Boston
Space is limited and pre-registration is required – Register Now

Join us for networking and a cutting-edge discussion of the FDA’s new open source research app platform called MyStudies. This new digital platform, announced in November 2018, enables researchers and developers to adapt MyStudies technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy, compliance with regulations and assist with safety monitoring. Data can be collected from a variety of sources, such as patient-generated and provided data including in home-use settings, or from data gathered from other sources, such as mobile device and external sensors.

Hear from Harvard Pilgrim Health Care and Boston Technology Corporation, two of the companies contracted by the FDA to create the open-source HIPAA and FISMA compliant platform that will encourage the development and use of mobile health technology for real world evidence collection and patient engagement. The open source code that serves as the foundation of the MyStudies platform, as well as specifications for a secure patient data storage environment, were developed through a collaboration with Harvard Pilgrim Health Care Institute, LabKey and Boston Technology Corporation. Continue reading “FEBRUARY 2019 – Innovation at the FDA: Introduction to MyStudies, An Open Source App and Platform for Patient Research”

NOVEMBER 2018 – Software as a Medical Device

Join us for our kickoff event for the HealthTech Boston group of Mobile Monday Boston.

A new era for digital therapeutics:  Medical treatments that incorporate software running on patient’s personal devices are starting to gain widespread acceptance.  Several new companies are building treatment pipelines of mobile apps that can be prescribed and reimbursed by insurance.  Meanwhile the pharmaceutical industry is producing a steady stream of companion apps that can integrate with devices in the home for drug delivery and data collection.

The FDA and Software as a Medical Device (SaMD):  The medical community and FDA are responding favorably to this trend.  Earlier this year, the FDA rolled out a pre-certification program for software as a medical device to address the needs of software developers who typically operate at a timescale of weeks instead of years.  In their words, an “agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products.”

Join us for an open discussion with: Ashley Mateus (Akili Interactive), Greg Stern (Sanofi), Jeremy Gilbert (Pear Therapeutics), and Carlos Rodarte (Volar Health) about the latest developments in digital therapeutics and Software as a Medical Device (SaMD).

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