Today no one can live without a smart phone, and we interact with the rest of the world through a series of apps that reside on our handheld devices. From the healthcare perspective many large healthcare institutions and private companies have developed a myriad of healthcare related apps that currently reside in Apple’s App Store and Googles Play Store. You can measure your heart rate, get clinical advice, view your records, check on your health insurance coverage, make appointments and virtually interact with many different types of healthcare providers. But even in today’s hyper-electronic society it took COVID-19 to really cause an explosion in telehealth, so what does that tell us? There is a lot more room for expanding electronic interactions with patients and clients through Apps. So, here are the top five legal concerns should you address when you develop a Healthcare App:
The Office of Civil Rights within the U.S. Department of Health and Human Services recently imposed $2,154,000 in civil money penalties against Jackson Health System in Miami, Florida for multiple violations of HIPAA. The majority of the penalties were due to violations of the HIPAA Security and Breach Notification Rules, rather than for the actual breaches of confidentiality. This action by the government underscores the importance of complying with all of HIPAA, and not just the requirements to safeguard Protected Health Information.
In the last few months, settlements related to potential violations of HIPAA and the Security Rule have ranged from $31,000 to $5.5 million. The smallest settlement amount, $31k, for potential HIPAA compliance breach violations related to one missing Business Associate Agreement (“BAA”) between a pediatric group and an ePHI records storage company that had come under HHS’ Office of Civil Right’s (“OCR”) scrutiny. The pediatric group used the ePHI record storage company since 2003, yet could not locate or provide a signed BAA to the OCR prior to 2015. The outcome of the OCR’s compliance review indicates that internal risk analysis and risk management was not thoroughly undertaken.
The largest settlement reached was $5.5 million to be paid by Memorial Healthcare Systems (“MHS”) located in south Florida. MHS operates 6 hospitals, an urgent care center, a nursing home, and numerous ancillary healthcare facilities. Additionally, MHS is affiliated with physician offices through an Organized Health Care Arrangement. MHS experienced a breach that potentially compromised the ePHI of over 115,000 individuals, when impermissible access by its employees and impermissible disclosure to affiliated physicians occurred through the use of the login credentials of an affiliated physician’s former employee. Although MHS reported the breach and had policies and procedures in place related to HIPAA and the Security Rule, it had not implemented procedures for reviewing, modifying, and/or terminating users’ rights of access as required by HIPAA. Further, MHS failed to regularly review records of information system activity, in applications that maintain ePHI, by employees or workforce users or users at affiliated physician practices, even though MHS had identified such risk during risk analysis conducted from 2007 to 2012.
Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase. Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.
How will audited businesses be selected?
This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities. OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit. As a part of these full audits, covered entities will be asked to identify their business associates. OCR will then select 50 business associates to participate.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.