{"id":5774,"date":"2016-04-16T11:47:00","date_gmt":"2016-04-16T11:47:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/want-to-know-which-fed-laws-apply-to\/"},"modified":"2019-02-21T01:15:06","modified_gmt":"2019-02-21T01:15:06","slug":"want-to-know-which-fed-laws-apply-to","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/want-to-know-which-fed-laws-apply-to\/","title":{"rendered":"Want to Know Which Fed Laws Apply to Your mHealth App? HHS Has an App for That!"},"content":{"rendered":"

I found this HHS Interactive Tool on the FTC website here<\/a>. <\/p>\n

\n<\/a><\/div>\n

<\/p>\n

\nDeveloping an mHealth App? Want to Know Which Federal Laws Apply? Use This HHS Interactive Tool<\/a><\/div>\n

\nI used this tool thinking of a few pharma mHealth apps I have seen. To see the results of that exercise, click on “Read more”.<\/p>\n

<\/a>The questions and my answers:<\/p>\n

1. Do you create, receive, maintain, or transmit identifiable health information?<\/p>\n

\nYES – I have seen a few pharma mHealth apps that collect & transmit such information. See, for example: “An Analysis of Genentech’s 4HER Mobile Health App Privacy Policy<\/a>“<\/p>\n

2. Are you a health care provider or health plan?<\/p>\n

\nNO<\/p>\n

3. Do consumers need a prescription to access your app? <\/p>\n

\nYES – I have seen one or two pharma mHealth apps that require a prescription before they can be used.<\/p>\n

4. Are you developing this app on behalf of a HIPAA covered entity (such as a hospital, doctor\u2019s office, health insurer, or health plan\u2019s wellness program)?<\/p>\n

\nNO<\/p>\n

5. Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?<\/p>\n

\nNO – Although I have come across a couple of pharma apps that meet this criterion. See, for example, “Janssen’s Psoriasis iPhone App<\/a>.” Some Rx drug branded pharma apps are labeled “Treatment Guide.” See, for example, “A Rare Rx Drug Branded Mobile App for Patients.<\/a>“<\/p>\n

If you answer YES to this question, the following federal laws may apply: The HIPAA Privacy Rule, The HIPAA Security Rule, The HIPAA Breach Notification Rule\n<\/p>\n

6. Does your app pose \u201cminimal risk\u201d to a user? According to the FDA, \u201cminimal risk\u201d apps are those that are only intended for one or more of the following:<\/p>\n