> Software Developers

Software developers need to comply with a variety of rules and regulations. If you create healthcare-related software, you may be considered a medical device and would be subject to FDA control, via the Mobile Media Guidance. Also, your software must be validated with predictable outcomes. According to HIPAA/HITECH, are you a covered entity or a business associate? The Kulkarni Law Firm’s Principal Attorney can provide help and advice.

Advisory Services Include:

  • Social Media Guidance: What you can and can’t say on social media.
  • Mobile Media Guidance: Whether you are considered a medical device and what regulations apply to you.
  • Adverse Event Reporting: What is allowed to be shared on the internet or social media.
  • Validation Assistance: How validation applies to you and how to validate.
  • HIPAA/HITECH Compliance: How to store confidential data, and are you exposed to liability via the privacy rule or the security rule.
  • Responding to Warning Letters: How to respond.
  • Training Programs: Contact us for details.

We can also offer support through a variety of other services, such as monitoring and risk assessments.

Contact the Firm today to inquire about your needs.

Disclaimer: The material on our website has been prepared and published for informational purposes only. There is no effort or intention to solicit new clients or new engagements from existing clients by way of this website, nor should any of the information published on the website be construed as representing any of our lawyers' availability to practice in jurisdictions where they are not authorized to do so.

None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.