Representing more than 5,000 app companies and information technology firms, ACT | The App Association is widely recognized as the foremost authority on the intersection of government and the app economy. In addition to drafting best practices, guidelines, and FAQs to help inform app companies about new legal obligations, ACT | The App Association hosts conferences, bootcamps and workshops to provide developers the resources they need to ensure compliance.
As the only organization focused on the needs of small business entrepreneurs from around the world, ACT | The App Association advocates for an environment that inspires and rewards innovation while providing resources to help its members leverage their intellectual assets to raise capital, create jobs, and continue innovating.
Here, Morgan Reed, executive director of the organization, discusses its goals, the app economy, how ACT | The App Association works across mobile health, innovations in the space and what’s likely to come in the year ahead.
What are the biggest barriers to entry for new health IT companies?
We have a “cascading” problem in the mobile health space right now. Regulatory guidance hasn’t kept pace with the rate of innovation, which has led to care providers being worried they will be exposed to liability, or will be providing services that aren’t covered by health plans.
It’s this fear and uncertainty that keeps hospital systems, independent practices, and individuals from adopting new technology, leaving care providers and patients to suffer as we wait for all the pieces to catch up.
What is ACT | The App Association doing to address issues facing mobile health companies?
ACT | The App Association is spearheading an effort to bring updates to outdated health privacy laws with a group we recently launched called the Connected Health Initiative. This coalition of leading mobile health companies and key stakeholders urge Congress, the Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) to adopt policies that encourage mobile health innovation.
How is ACT | The App Association working with Congress and the Department of Health and Human Services to bring clarity to the outdated regulatory environment facing mobile health companies?
Most recently, ACT | The App Association and a number of our member companies, all of which are part of the newly formed Connected Health Initiative, called on Congress to bring much needed updates to the Health Insurance Portability and Accountability Act (HIPAA). We outlined changes needed from the Department of Health and Human Services (HHS) to ensure HIPAA fits better in today’s mobile world.
Make existing regulation more accessible for tech companies. Information on HIPAA is still mired in a Washington, D.C. mindset that revolves around reading the Federal Register, or hiring expert consultants to ‘explain’ what should be clear in the regulation itself. Not surprisingly, app makers do not find the Federal Register to be an effective resource when developing health apps.
Additionally, there are limited user-friendly resources available for app developers, who are mostly solo inventors or small groups of designers – not large companies with the resources to easily hire counsel or consultants who can help through the regulatory process.
Proposed solution: HHS must provide HIPAA information in a manner that is accessible and useful to the community who needs it. The agency should draft new FAQs that directly address mobile developer concerns.
Improve and update guidance from OCR on acceptable implementations. The current technical safeguards documentation available on the hhs.gov website is significantly out of date. Without new documentation that speaks to more modern uses, it will be difficult for developers to understand how to implement HIPAA in an effective way for patients.
Proposed solution: HHS and OCR must update the ‘Security Rule Guidance Material’ and provide better guidance regarding mobile implementations and standards – or examples of standard implementations that would not trigger an enforcement action – instead of leaving app makers to learn about these through an audit.
Improve outreach to new entrants in the healthcare space. Some of the most innovative new products in the mobile health space are coming from companies outside the traditional healthcare marketplace. Yet HHS appears attached to ‘traditional’ healthcare communities.
Proposed solution: In order to ensure the expansion of innovative new technologies, it is essential that HHS, OCR and others expand their outreach to the communities that are driving innovation.
How would you describe the reaction from Congress and HHS to your work in this area?
Congressmen Tom Marino (R-PA) and Peter DeFazio (D-OR) were swift to act, sending a letter within days to HHS Secretary Sylvia Burwell that outlined several steps the agency should take to provide clarity surrounding confusion on HIPAA. The app industry has long looked to Congressmen Marino and DeFazio for their leadership on tech issues, and we are pleased to see their strong commitment to the success of mobile health innovation.
Following the Congressional action, Secretary Burwell pledged to bring clarity to HIPAA for the mobile world. In a letter to Congress, Secretary Burwell promised to work with ACT | The App Association and mobile health companies to make the regulatory environment better for innovators in the space. The commitment from both Congress and HHS underscores that changes to HIPAA guidance documents can be made without legislation.
We look forward to working with Congress and HHS to create a better regulatory environment that encourages innovation in mobile health.
Can you discuss some of the innovative health IT companies with which you work?
San Antonio-based AirStrip makes technology that allows care providers to access health records and waveform data from a remote location prior to seeing a patient. Their applications expedite care decisions and give clinicians a comprehensive understanding of patient health before entering a hospital room.
Aptible, from New York City, provides a service that ensures health apps properly protect patient data and comply with federal privacy requirements. When a company runs their applications and databases, Aptible isolates and reduces security risks ensuring the safety of a user’s health information.
Salt Lake City company Orca Health makes multi-sensory learning tools for care providers to help better engage patients with information about their health. Their series of iPad and iPhone apps provide simple illustrations of treatment risks and benefits, improving the healthcare experience for all parties involved.
CareSync, from Wesley Chapel, Florida, builds user-friendly applications that provide a single repository for all of an individual’s health related information and needs. Their system connects people with their personal health data, redefining the patient’s role to create better outcomes.
In 2014, what were some of the biggest innovations released in the mobile health sphere?
The wearables explosion and widespread adoption was a major shift in how healthcare providers see patient information. And inside medical practices, 2014 was the year of grasping the possibility of real-time patient information on a mobile screen.
What type of mobile health innovations do you expect to see in 2015? Where is health IT headed?
I think the biggest innovations and struggles will come from the patient side of healthcare. Engaged patients will more readily send information to doctors and expect an answer, and disengaged patients will be those we try to reach through mobile compliance and adherence apps.